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Review
. 2023 Aug 24;8(8):CD009672.
doi: 10.1002/14651858.CD009672.pub3.

Hormone therapy for sexual function in perimenopausal and postmenopausal women

Lucia A Lara  1 , Denisse Cartagena-Ramos  2 , Jaqueline Bp Figueiredo  1   3 , Ana Carolina Js Rosa-E-Silva  1 , Rui A Ferriani  1 , Wellington P Martins  4 , Miguel Fuentealba-Torres  5
Affiliations
Review

Hormone therapy for sexual function in perimenopausal and postmenopausal women

Lucia A Lara et al. Cochrane Database Syst Rev. .

Abstract

Background: The perimenopausal and postmenopausal periods are associated with many symptoms, including sexual complaints. This review is an update of a review first published in 2013.

Objectives: We aimed to assess the effect of hormone therapy on sexual function in perimenopausal and postmenopausal women.

Search methods: On 19 December 2022 we searched the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, LILACS, ISI Web of Science, two trials registries, and OpenGrey, together with reference checking and contact with experts in the field for any additional studies.

Selection criteria: We included randomized controlled trials that compared hormone therapy to either placebo or no intervention (control) using any validated assessment tool to evaluate sexual function. We considered hormone therapy: estrogen alone; estrogen in combination with progestogens; synthetic steroids, for example, tibolone; selective estrogen receptor modulators (SERMs), for example, raloxifene, bazedoxifene; and SERMs in combination with estrogen.

Data collection and analysis: We used standard methodological procedures recommended by Cochrane. We analyzed data using mean differences (MDs) and standardized mean differences (SMDs). The primary outcome was the sexual function score. Secondary outcomes were the domains of sexual response: desire; arousal; lubrication; orgasm; satisfaction; and pain. We assessed the certainty of the evidence using the GRADE approach.

Main results: We included 36 studies (23,299 women; 12,225 intervention group; 11,074 control group), of which 35 evaluated postmenopausal women; only one study evaluated perimenopausal women. The 'symptomatic or early postmenopausal women' subgroup included 10 studies, which included women experiencing menopausal symptoms (symptoms such as hot flushes, night sweats, sleep disturbance, vaginal atrophy, and dyspareunia) or early postmenopausal women (within five years after menopause). The 'unselected postmenopausal women' subgroup included 26 studies, which included women regardless of menopausal symptoms and women whose last menstrual period was more than five years earlier. No study included only women with sexual dysfunction and only seven studies evaluated sexual function as a primary outcome. We deemed 20 studies at high risk of bias, two studies at low risk, and the other 14 studies at unclear risk of bias. Nineteen studies received commercial funding. Estrogen alone versus control probably slightly improves the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.50, 95% confidence interval (CI) (0.04 to 0.96; I² = 88%; 3 studies, 699 women; moderate-quality evidence), and probably makes little or no difference to the sexual function composite score in unselected postmenopausal women (SMD 0.64, 95% CI -0.12 to 1.41; I² = 94%; 6 studies, 608 women; moderate-quality evidence). The pooled result suggests that estrogen alone versus placebo or no intervention probably slightly improves sexual function composite score (SMD 0.60, 95% CI 0.16 to 1.04; I² = 92%; 9 studies, 1307 women, moderate-quality evidence). We are uncertain of the effect of estrogen combined with progestogens versus placebo or no intervention on the sexual function composite score in unselected postmenopausal women (MD 0.08 95% CI -1.52 to 1.68; 1 study, 104 women; very low-quality evidence). We are uncertain of the effect of synthetic steroids versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 1.32, 95% CI 1.18 to 1.47; 1 study, 883 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 0.46, 95% CI 0.07 to 0.85; 1 study, 105 women; very low-quality evidence). We are uncertain of the effect of SERMs versus control on the sexual function composite score in symptomatic or early postmenopausal women (MD -1.00, 95% CI -2.00 to -0.00; 1 study, 215 women; very low-quality evidence) and of their effect in unselected postmenopausal women (MD 2.24, 95% 1.37 to 3.11 2 studies, 1525 women, I² = 1%, low-quality evidence). We are uncertain of the effect of SERMs combined with estrogen versus control on the sexual function composite score in symptomatic or early postmenopausal women (SMD 0.22, 95% CI 0.00 to 0.43; 1 study, 542 women; very low-quality evidence) and of their effect in unselected postmenopausal women (SMD 2.79, 95% CI 2.41 to 3.18; 1 study, 272 women; very low-quality evidence). The observed heterogeneity in many analyses may be caused by variations in the interventions and doses used, and by different tools used for assessment.

Authors' conclusions: Hormone therapy treatment with estrogen alone probably slightly improves the sexual function composite score in women with menopausal symptoms or in early postmenopause (within five years of amenorrhoea), and in unselected postmenopausal women, especially in the lubrication, pain, and satisfaction domains. We are uncertain whether estrogen combined with progestogens improves the sexual function composite score in unselected postmenopausal women. Evidence regarding other hormone therapies (synthetic steroids and SERMs) is of very low quality and we are uncertain of their effect on sexual function. The current evidence does not suggest the beneficial effects of synthetic steroids (for example tibolone) or SERMs alone or combined with estrogen on sexual function. More studies that evaluate the effect of estrogen combined with progestogens, synthetic steroids, SERMs, and SERMs combined with estrogen would improve the quality of the evidence for the effect of these treatments on sexual function in perimenopausal and postmenopausal women.

Trial registration: ClinicalTrials.gov NCT00408863 NCT00238732 NCT00000611 NCT01585558 NCT02253173 NCT02638337 NCT03018106 NCT02460302 NCT03363997 NCT03116022.

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Conflict of interest statement

Miguel Fuenteallba‐Tores declares no relationships or activities that could have influenced the submitted work.

Lucia A Lara declares no relationships or activities that could have influenced the submitted work.

Denisse Cartagena‐Ramos declares no relationships or activities that could have influenced the submitted work.

Jaqueline BP Figueiredo declares no relationships or activities that could have influenced the submitted work.

Ana Carolina JS Rosa‐e‐Silva declares no relationships or activities that could have influenced the submitted work.

Rui A Ferriani declares no relationships or activities that could have influenced the submitted work.

Wellington P Martins declares no relationships or activities that could have influenced the submitted work.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
4
4
Forest plot of comparison: 1 Estrogens alone versus placebo/no treatment, outcome: 1.1 Sexual function composite score.
5
5
Forest plot of comparison: 2 Estrogens + progestogens versus placebo/no treatment, outcome: 2.1 Sexual function composite score.
6
6
Forest plot of comparison: 3 Synthetic steroids versus placebo/no treatment, outcome: 3.1 Sexual function composite score.
7
7
Forest plot of comparison: 4 Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, outcome: 4.1 Sexual function composite score.
8
8
Forest plot of comparison: 5 Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, outcome: 5.1 Sexual function composite score.
1.1
1.1. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 1: Sexual function composite score
1.2
1.2. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 2: Desire
1.3
1.3. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 3: Arousal
1.4
1.4. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 4: Lubrication
1.5
1.5. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 5: Orgasm
1.6
1.6. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 6: Satisfaction
1.7
1.7. Analysis
Comparison 1: Estrogen alone versus placebo/no treatment, Outcome 7: Pain
2.1
2.1. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 1: Sexual function composite score
2.2
2.2. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 2: Desire at 16‐month follow‐up
2.3
2.3. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 3: Desire at 22‐ and 24‐month follow‐up
2.4
2.4. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 4: Arousal
2.5
2.5. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 5: Lubrication
2.6
2.6. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 6: Orgasm
2.7
2.7. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 7: Satisfaction
2.8
2.8. Analysis
Comparison 2: Estrogen + progestogens versus placebo/no treatment, Outcome 8: Pain
3.1
3.1. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 1: Sexual function composite score
3.2
3.2. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 2: Desire at 12‐month follow‐up
3.3
3.3. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 3: Desire at 24‐month follow‐up
3.4
3.4. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 4: Arousal at 12‐month follow‐up
3.5
3.5. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 5: Arousal at 24‐month follow‐up
3.6
3.6. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 6: Lubrication at 12‐month follow‐up
3.7
3.7. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 7: Lubrication at 24‐month follow‐up
3.8
3.8. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 8: Orgasm at 12‐month follow‐up
3.9
3.9. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 9: Orgasm at 24‐month follow‐up
3.10
3.10. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 10: Satisfaction
3.11
3.11. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 11: Pain at 12‐month follow‐up
3.12
3.12. Analysis
Comparison 3: Synthetic steroids versus placebo/no treatment, Outcome 12: Pain at 24‐month follow‐up
4.1
4.1. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 1: Sexual function composite score
4.2
4.2. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 2: Desire
4.3
4.3. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 3: Arousal
4.4
4.4. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 4: Lubrication
4.5
4.5. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 5: Orgasm
4.6
4.6. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 6: Satisfaction
4.7
4.7. Analysis
Comparison 4: Selective estrogen receptor modulators (SERMs) versus placebo/no treatment, Outcome 7: Pain
5.1
5.1. Analysis
Comparison 5: Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, Outcome 1: Sexual function composite score
5.3
5.3. Analysis
Comparison 5: Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, Outcome 3: Arousal
5.4
5.4. Analysis
Comparison 5: Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, Outcome 4: Lubrication
5.5
5.5. Analysis
Comparison 5: Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, Outcome 5: Orgasm
5.6
5.6. Analysis
Comparison 5: Selective estrogen receptor modulators (SERMs) + estrogens versus placebo/no treatment, Outcome 6: Satisfaction
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

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Maki 2007 {published data only}
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Mitchell 2018 {published data only}
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Modugno 2003 {published data only}
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Yang 2004 {published data only}
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References to studies excluded from this review

2010‐024603‐26 {unpublished data only}
    1. 2010-024603-26. A phase II study of low-dose vaginal estrogens in pre and postmenopausal breast cancer patients with urogenital atrophy. https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_nu... (first entered 1 March 2012). [EUCTR: 2010-024603-26-IT]
2014‐000179‐18 {unpublished data only}
    1. 2014-000179-18. Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) [Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) - feasibility study]. https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000179-18/GB (first entered 10 March 2015). [EUCTR: 2014-000179-18-GB]
Abedi 2018 {published data only}
    1. Abedi P, Najafian M, Yaralizadeh M, Namjoyan F. Effect of fennel vaginal cream on sexual function in postmenopausal women: a double blind randomized controlled trial. Journal of Medicine and Life 2018;11(1):24-8. [PMID: ] - PMC - PubMed
Abedi 2020 {published data only}
    1. Abedi P, Zohrabi I, Ansari S, Maraghi E, Maram NS, Houshmand G. The impact of oxytocin vaginal gel on sexual function in postmenopausal women: a randomized controlled trial. Journal of Sex & Marital Therapy 2020;46(4):337-84. [PMID: ] - PubMed
Abraham 2014 {published data only}
    1. Abraham L, Messig M, Pinkerton JV, Mirkin S, Ryan K. Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. Menopause (New York, N.Y.) 2014;78(3):212-18. [PMID: ] - PubMed
Adler 2005 {published data only}
    1. Adler G, Young D, Galant R, Quinn L, Witchger MS, Maki KC. A multicenter, open-label study to evaluate satisfaction and menopausal quality of life in women using transdermal estradiol/norethindrone acetate therapy for the management of menopausal signs and symptoms. Gynecologic and Obstetric Investigation 2005;59(4):212-9. [PMID: ] - PubMed
Almeida 2006 {published data only}
    1. Almeida OP, Lautenschlager NT, Vasikaran S, Leedman P, Gelavis A, Flicker L. A 20-week randomized controlled trial of estradiol replacement therapy for women aged 70 years and older: effect on mood, cognition and quality of life. Neurobiology of Aging 2006;27(1):141-9. [PMID: ] - PubMed
Aptecar 2021 {published data only}
    1. Aptecar L, Fiteni F, Jarlier M, Delaine S, Guillerme V, Jacot W, et al. Prospective evaluation of sexual health in breast cancer women during the first year of adjuvant hormonal treatment using a cancer patient's dedicated questionnaire: a glaring gap of communication between health professionals and patients. Breast Cancer Research and Treatment 2021;18(3):705-13. [DOI: 10.1007/s10549-020-06062-x] [PMID: ] - DOI - PubMed
Archer 2011 {published data only}
    1. Archer DF, Pickar JH, MacAllister DC, Warren M. Transdermal estradiol gel for the treatment of symptomatic postmenopausal women. Menopause 2011;18(12):1324-55. [PMID: ] - PubMed
Arêas 2019 {published data only}
    1. Arêas F, Valadares AL, Conde DM, Costa-Paiva L. The effect of vaginal erbium laser treatment on sexual function and vaginal health in women with a history of breast cancer and symptoms of the genitourinary syndrome of menopause: a prospective study. Menopause 2019;26(9):1052-8. - PubMed
Argyroudis 1997 {published data only}
    1. Argyroudis EM, Iatrakis G, Kourkoubas A, Georgoulias N, Kourounis G, Tsionis C, et al. Tibolone in the treatment of psychosomatic symptoms in menopause. Clinical and Experimental Obstetrics & Gynecology 1997;24(3):167-8. [PMID: ] - PubMed
Bachmann 2008 {published data only}
    1. Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstetrics and Gynecology 2008;111(1):67-76. [PMID: ] - PubMed
Bachmann 2009 {published data only}
    1. Bachmann GA, Schaefers M, Uddin A, Utian WH. Microdose transdermal estrogen therapy for relief of vulvovaginal symptoms in postmenopausal women. Menopause 2009;16(5):877-82. [PMID: ] - PubMed
Bachmann 2010 {published data only}
    1. Bachmann GA, Komi JO, Ospemifene Study Group. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause 2010;17(3):480-6. [PMID: ] - PubMed
Bachmann 2011 {published data only}
    1. Bachmann G, Crosby U, Feldman RA, Ronkin S, Constantine GD. Effects of bazedoxifene in nonflushing postmenopausal women: a randomized phase 2 trial. Menopause 2011;18(5):508-14. [PMID: ] - PubMed
Barnabei 2002 {published data only}
    1. Barnabei VM, Grady D, Stovall DW, Cauley JA, Lin F, Stuenkel CA, et al. Menopausal symptoms in older women and the effects of treatment with hormone therapy. Obstetrics and Gynecology 2002;100(6):1209-18. [PMID: ] - PubMed
Bennink 2016 {published data only}
    1. Bennink HC, Verhoven C, Zimmerman Y, Visser M, Foidart J-M, Gemzell-Danielsson K. Clinical effects of the fetal estrogen estetrol in a multiple-rising-dose study in postmenopausal women. Maturitas 2016;91:93-100. [PMID: ] - PubMed
Bianchi‐Ferraro 2022 {published data only}
    1. Bianchi-Ferraro AM, Dia Oliveira C, Speck N, Campos M, Nogueira MC, Marair Gracio Ferreira S, et al. Analysis of clinical response, sexuality and vaginal health in women with genitourinary syndrome of menopause treated with topical estrogen, microablative fractional CO 2 laser and microablative fractional radiofrequency: randomized controlled trial. International Urogynecology Journal 2022;33 Suppl 2:173–519. [DOI: 10.1007/s00192-022-05295-2] - DOI
Binder 2001 {published data only}
    1. Binder EF, Schechtman KB, Birge SJ, Williams DB, Kohrt WM. Effects of hormone replacement therapy on cognitive performance in elderly women. Maturitas 2001;38(2):137-46. [PMID: ] - PubMed
Blumel 2008 {published data only}
    1. Blümel JE, Del Pino M, Aprikian D, Vallejo S, Sarrá S, Castelo-Branco C. Effect of androgens combined with hormone therapy on quality of life in post-menopausal women with sexual dysfunction. Gynecological Endocrinology 2008;24(12):691-5. [PUBMED: 19172538] - PubMed
Bosak 2022 {published data only}
    1. Bosak Z, Iravani M, Moghimipour E, Haghighizadeh MH, Jelodarian P. Effect of chamomile vaginal gel on the sexual function in postmenopausal women: a double-blind randomized controlled trial. Journal of Sexual Medicine 2022;19(6):983-94. [DOI: ] [PMID: ] - PubMed
Bride 2014 {published data only}
    1. Bride M, Shuster L, Rhodes D, Grossardt B, Warndahl R, Debra B. Low dose vaginal estrogens for the treatment of vulvovaginal atrophy: a randomized, placebo-controlled trial evaluating effect of estriol, estradiol or placebo on vulvovaginal atrophy symptoms. Journal of Sexual Medicine 2014;11:220-1.
Bruno 2012 {published data only}
    1. Bruno RV. Treatment of urogenital atrophy with the local administration of oestrogens: a randomized, controlled study in climateric and postmenopausal women [Tratamento da atrofia urogenital com a administração local de estrogênios: um estudo randomizado, controlado em mulheres no climatério e na pós-menopausa]. Revista Brasileira de Medicina 2012;69(8-9):230-5.
Cano 2012 {published data only}
    1. Cano A, Estévez J, Usandizaga R, Gallo JL, Guinot M, Delgado JL, et al. The therapeutic effect of a new ultra low concentration estriol gel formulation (0.005% estriol vaginal gel) on symptoms and signs of postmenopausal vaginal atrophy: results from a pivotal phase III study. Menopause 2012;19(10):1130-9. [PMID: ] - PubMed
Cardozo 2001 {published data only}
    1. Cardozo LD, Wise BG, Benness CJ. Vaginal oestradiol for the treatment of lower urinary tract symptoms in postmenopausal women--a double-blind placebo-controlled study. Journal of Obstetrics and Gynaecology 2001;21(4):383-5. [PMID: ] - PubMed
Casper 1999 {published data only}
    1. Casper F, Petri E. Local treatment of urogenital atrophy with an estradiol-releasing vaginal ring: a comparative and a placebo-controlled multicenter study. Vaginal Ring Study Group. International Urogynecology Journal and Pelvic Floor Dysfunction 1999;10(3):171-6. [PMID: ] - PubMed
Castelo‐Branco 2000 {published data only}
    1. Castelo-Branco C, Vicente JJ, Figueras F, Sanjuan A, Martinez de Osaba MJ, Casals E, et al. Comparative effects of estrogens plus androgens and tibolone on bone, lipid pattern and sexuality in postmenopausal women. Maturitas 2000;34(2):161-8. [PMID: ] - PubMed
Cayan 2008 {published data only}
    1. Cayan F, Dilek U, Pata O, Dilek S. Comparison of the effects of hormone therapy regimens, oral and vaginal estradiol, estradiol + drosperinone and tibolone on sexual function in healthy postmenopausal women. Journal of Sexual Medicine 2008;5(1):132-8. [PMID: ] - PubMed
Ceausu 2011 {published data only}
    1. Ceausu I, Posea C, Hudit D. Tibolone treatment - different doses and regimens. Climacteric 2011;14:117.
Concepcion 2011 {published data only}
    1. Concepcion N, Cano A, Estevez J, Usandizaga R, Gallo JL, Guinot M, et al. 0.005% estriol vaginal gel, a new formulation delivering an ultra-low dose of estriol per application (50 mg), is a novel treatment for postmenopausal vaginal atrophy. Climacteric 2011;14:86.
    1. Nieto C, Ferrer J, Castellanos E, Casanova A, De La Calle M, Delgado JL, et al. Efficacy of an ultra low dose estriol vaginal gel in treating postmenopausal women with vaginal dryness as their most bothersome symptom. Climacteric 2011;14:156.
Cruz 2018 {published data only}
    1. Cruz VL, Steiner ML, Pompei LM, Strufaldi R, Fonseca FLA, Santiago LH, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause 2018;25(1):21-8. [PMID: ] - PubMed
Dalil 2020 {published data only}
    1. Dalil H, KaboudMehri R, Mojab F, Sahranavard S, Nasiri M, Ozgoli G. Effect of Vitex agnus-castus plant on sexual function in women of reproductive age. Iranian Journal of Obstetrics, Gynecology and Infertility 2020;23(4):62-74.
Daneshmand 2015 {published data only}
    1. Daneshmand F, Hosseinzadeh P, Ghahiri A, Ghasemi M. A comparative study of vaginal estrogen cream and sustained released estradiol vaginal tablet (Vagifem) in the treatment of atrophic vaginitis among postmenopausal women. Journal of Research in Medical Sciences 2015;20(12):1160-5. [PMID: ] - PMC - PubMed
Dennerstein 1980 {published data only}
    1. Dennerstein L, Burrows GD, Hyman GJ, Sharpe K. Some clinical effects of oestrogen-progestogen therapy in surgically castrated women. Maturitas 1980;2(1):19-28. [PMID: ] - PubMed
Dessole 2004 {published data only}
    1. Dessole S, Rubattu G, Ambrosini G, Gallo O, Capobianco G, Cherchi PL, et al. Efficacy of low-dose intravaginal estriol on urogenital aging in postmenopausal women. Menopause 2004;11(1):49-56. [PMID: ] - PubMed
Diem 2006 {published data only}
    1. Diem S, Grady D, Quan J, Vittinghoff E, Wallace R, Hanes V, et al. Effects of ultralow-dose transdermal estradiol on postmenopausal symptoms in women aged 60 to 80 years. Menopause 2006;13(1):130-8. [PMID: ] - PubMed
Ditkoff 1991 {published data only}
    1. Ditkoff EC, Crary WG, Cristo M, Lobo RA. Estrogen improves psychological function in asymptomatic postmenopausal women. Obstetrics and Gynecology 1991;78(6):991-5. [PMID: ] - PubMed
DRKS00006888 {published data only}
    1. DRKS00006888. Post market clinical follow-up study of the use of the vaginal cream Remifemin® FeuchtCreme (RFC) [Post market clinical follow-up study of the use of the vaginal cream Remifemin® FeuchtCreme (RFC)]. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRI... (registered 20 October 2014). [DRKS-ID DER STUDIE: DRKS00006888]
Duka 2000 {published data only}
    1. Duka T, Tasker R, McGowan JF. The effects of 3-week estrogen hormone replacement on cognition in elderly healthy females. Psychopharmacology 2000;149(2):129-39. [PMID: ] - PubMed
Eftekhar 2009 {published data only}
    1. Eftekhar T, Akhoondzadeh S, Ghanbari Z, Iranshahr R, Haghollahi F. Effect of vaginal estrogen on post menopausal mood & sleep disturbance/ and sexual satisfaction [Investigating the effect of vaginal estrogen on mood and sleep disorders and sexual satisfaction in postmenopausal women]. Tehran University Medical Journal 2009;67(2):118-24.
Eftekhar 2020 {published data only}
    1. Eftekhar T, Forooghifar T, Khalili T, Shariat M, Haghollahi F. The effect of the CO 2 fractional laser or Premarin vaginal cream on improving sexual function in menopausal women: a randomized controlled trial. Journal of Lasers in Medical Sciences 2020;11(3):292-8. - PMC - PubMed
Eriksen 1992 {published data only}
    1. Eriksen PS, Rasmussen H. Low-dose 17 beta-estradiol vaginal tablets in the treatment of atrophic vaginitis: a double-blind placebo controlled study. European Journal of Obstetrics, Gynecology, and Reproductive Biology 1992;44(2):137-44. [PMID: ] - PubMed
Eriksen 1999 {published data only}
    1. Eriksen B. A randomized, open, parallel-group study on the preventive effect of an estradiol-releasing vaginal ring (Estring) on recurrent urinary tract infections in postmenopausal women. American Journal of Obstetrics and Gynecology 1999;180(5):1072-9. [PMID: ] - PubMed
Fabian 2019 {published data only}
    1. Fabian C, Nye L, Powers K, Nydegger J, Kreutzjans A, Phillips T, et al. Effect of bazedoxifene and conjugated estrogen (Duavee) on breast cancer risk biomarkers in high-risk women: a pilot study. Cancer Prevention Research (Philadelphia, Pa.) 2019;12(10):711-20. [PMID: ] - PMC - PubMed
Fernandes 2014 {published data only}
    1. Fernandes T, Costa-Paiva LH, Pedro AO, Baccaro LF, Pinto-Neto AM. Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on vaginal atrophy: a randomized controlled trial. Menopause 2016;23(7):792-8. [PMID: ] - PubMed
Freedman 2009 {published data only}
    1. Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause 2009;16(4):735-41. [PMID: ] - PubMed
Galesanu 2010 {published data only}
    1. Galesanu C, Lisnic N, Moisii L, Galesanu RG, Onofriescu M. Effect of hormone replacement therapy on sexual dysfunction in postmenopausal women. Gineco.ro Romania Pulsmedia Network 2010;6(3):186-91.
Galhardo 2006 {published data only}
    1. Galhardo CL, Soares JM Jr, Simões RS, Haidar MA, Rodrigues de Lima G, Baracat EC. Estrogen effects on the vaginal pH, flora and cytology in late postmenopause after a long period without hormone therapy. Clinical and Experimental Obstetrics & Gynecology 2006;33(2):85-9. [PMID: ] - PubMed
Garcia de Arriba 2022 {published data only}
    1. Garcia de Arriba S, Gruntkemeier L, Hauser M, May TW, Masur C, Stute P. Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: prospective, randomised study. Menopause 2021;28(7):748-55. [DOI: 10.1097/GME.0000000000001766] [PMID: ] - DOI - PMC - PubMed
Gaspard 2021 {published data only}
    1. Gaspard U, Taziaux M, Jost M, Lobo R, Foidart JM. Effects of estetrol on vaginal cytology, genitourinary syndrome of menopause and health-related quality of life: results from the E4Relief Phase 2b Study. In: Maturitas. Conference: 13th Virtual Congress of the European Menopause, EMAS 2021. Vol. 152. 2021:71. [DOI: 10.1016/j.maturitas.2021.08.019] - DOI
Gonenne 2006 {published data only}
    1. Gonenne J, Esfandyari T, Camilleri M, Burton DD, Stephens DA, Baxter KL, et al. Effect of female sex hormone supplementation and withdrawal on gastrointestinal and colonic transit in postmenopausal women. Neurogastroenterology and Motility 2006;18(10):911-8. [PMID: ] - PubMed
Gorenstein 2011 {published data only}
    1. Gorenstein C, Rennó J Jr, Vieira Filho AH, Gianfaldoni A, Gonçalves MA, Halbe HW, et al. Estrogen replacement therapy and cognitive functions in healthy postmenopausal women: a randomized trial. Archives of Women's Mental Health 2011;14(5):367-73. [PMID: ] - PubMed
Griesser 2012 {published data only}
    1. Griesser H, Skonietzki S, Fischer T, Fielder K, Suesskind M. Low dose estriol pessaries for the treatment of vaginal atrophy: a double-blind placebo-controlled trial investigating the efficacy of pessaries containing 0.2 mg and 0.03 mg estriol. Maturitas 2012;71(4):360-8. [PMID: ] - PubMed
Guan 2010 {published data only}
    1. Guan YT, Cai LL, Ding HX, Chen GD, Hu Y. Clinical study on combination of multiple regimens in treatment of osteoporosis in perimenopause and postmenopausal women. Zhonghua Fu Chan Ke Za Zhi 2010;45(8):571-4. [PMID: ] - PubMed
Hachul 2008 {published data only}
    1. Hachul H, Bittencourt LR, Andersen ML, Haidar MA, Baracat EC, Tufik S. Effects of hormone therapy with estrogen and/or progesterone on sleep pattern in postmenopausal women. International Journal of Gynaecology and Obstetrics 2008;103(3):207-12. [PMID: ] - PubMed
Harman 2014 {published data only}
    1. Harman S, Black D, Naftolin F, Brinton E, Budoff M, Cedars M, et al. Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: a randomized trial. Annals of Internal Medicine 2014;161:249-60. - PubMed
Hedrick 2009 {published data only}
    1. Hedrick RE, Ackerman RT, Koltun WD, Halvorsen MB, Lambrecht LJ. Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women. Menopause 2009;16(1):132-40. [PMID: ] - PubMed
Hendrix 2005 {published data only}
    1. Hendrix SL, Cochrane BB, Nygaard IE, Handa VL, Barnabei VM, Iglesia C, et al. Effects of estrogen with and without progestin on urinary incontinence. JAMA 2005;293(8):935-48. [PMID: ] - PubMed
Hodis 2001 {published data only}
    1. Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, et al. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine 2001;135(11):939-53. [PMID: ] - PubMed
Hofling 2005 {published data only}
    1. Hofling M, Carlstrom K, Svane G, Azavedo E, Kloosterboer H, Von Schoultz B. Different effects of tibolone and continuous combined estrogen plus progestogen hormone therapy on sex hormone binding globulin and free testosterone levels--an association with mammographic density. Gynecological Endocrinology 2005;20(2):110-5. [PMID: ] - PubMed
IRCT138809032766N1 {published data only}
    1. IRCT138809032766N1. Comparative effects of 2 types of hormone replacement therapy on climacteric symptoms [Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women]. https://www.irct.ir/trial/2605 (registered 26 April 2010). [IRCT: 138809032766N1] - PubMed
IRCT2017050433817N1 {published data only}
    1. IRCT2017050433817N1. Laser vs vaginal conjugated estrogen in postmenopausal women [Evaluation of efficacy and safety of fractional CO2 vs vaginal conjugated estrogen in postmenopausal women diagnosed as having vulvovaginal atrophy]. https://www.irct.ir/trial/25991 (registered 8 June 2017). [IRCT: 2017050433817N1]
Islam 2021 {published data only}
    1. Islam RM, Davis SR, Bell RJ, Tejada-Berges T, Wrede CD, Domchek SM, et al. A prospective controlled study of sexual function and sexually related personal distress up to 12 months after premenopausal risk-reducing bilateral salpingo-oophorectom. Menopause 2021;28(7):748-55. [DOI: 10.1097/GME.0000000000001766] [PMID: ] - DOI - PubMed
ISRCTN46661996 {published data only}
    1. ISRCTN46661996. Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery [Local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) feasibility study]. https://doi.org/10.1186/ISRCTN46661996 (registered 28 May 2015). [ISRCTN: 46661996]
Jensen 1983 {published data only}
    1. Jensen J, Christiansen C. Dose-response and withdrawal effects on climacteric symptoms after hormonal replacement therapy. A placebo-controlled therapeutic trial. Maturitas 1983;5(2):125-33. [PMID: ] - PubMed
Ju 2021 {published data only}
    1. Ju R, Ruan X, Xu X, Yang Y, Cheng J, Zhang L, et al. Sexual dysfunction in Chinese women at different reproductive stages and the positive effect of hormone replacement therapy in the early postmenopause. European Journal of Contraception & Reproductive Health Care 2021;26(3):246-54. [DOI: 10.1080/13625187.2020.1867843https://dx.doi.org/10.1080/13625187.2020.1867843] - DOI - PubMed
Kagan 2014 {published data only}
    1. Kagan R, Portman D, Archer D, Graham S, Constantine G. Responder analysis of ospemifene treatment for vulvar and vaginal atrophy in postmenopausal women in phase 3 randomized, placebo-controlled trials. Menopause (New York, N.Y.) 2014;21:1332.
Kenny 2005 {published data only}
    1. Kenny AM, Kleppinger A, Wang Y, Prestwood KM. Effects of ultra-low-dose estrogen therapy on muscle and physical function in older women. Journal of the American Geriatrics Society 2005;53(11):1973-7. [PMID: ] - PubMed
Kessel 2003 {published data only}
    1. Kessel B, Nachtigall L, Plouffe L, Siddhanti S, Rosen A, Parsons A. Effect of raloxifene on sexual function in postmenopausal women. Climacteric 2003;6(3):248-56. [PMID: ] - PubMed
Kimura 1995 {published data only}
    1. Kimura D. Estrogen replacement therapy may protect against intellectual decline in postmenopausal women. Hormones and Behavior 1995;29(3):312-21. [PMID: ] - PubMed
Kingsberg 2017 {published data only}
    1. Kingsberg S, Kroll R, Goldstein I, Constantine G, Bernick B, Graham S, et al. Product acceptability and women's satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004H. Journal of Sexual Medicine 2017;14(6 Suppl 5):e355. - PMC - PubMed
Kocoska‐Maras 2011 {published data only}
    1. Kocoska-Maras L, Zethraeus N, Rådestad AF, Ellingsen T, Schoultz B, Johannesson M, et al. A randomized trial of the effect of testosterone and estrogen on verbal fluency, verbal memory, and spatial ability in healthy postmenopausal women. Fertility and Sterility 2011;95(1):152-7. [PMID: ] - PubMed
Kornafel 1992 {published data only}
    1. Kornafel KL, March CM. Estradiol gel in the treatment of menopausal symptoms: a placebo-controlled double-blind case study of efficacy and safety. Southern Medical Journal 1992;85(3):270-3. [PMID: ] - PubMed
Kroll 2018 {published data only}
    1. Kroll R. A randomized, multicenter, double-blind study to evaluate the safety and efficacy of estradiol vaginal cream 0.003% in postmenopausal women with dyspareunia as the most bothersome symptom. Menopause 2018;25(2):133-8. [PMID: ] - PMC - PubMed
Krychman 2016 {published data only}
    1. Krychman M, Symons J, Portman D. Correlation of physiologic markers of vulvovaginal atrophy and symptom severity in postmenopausal women with genitourinary syndrome of menopause. Journal of Sexual Medicine 2016;13:S248.
Kumru 2008 {published data only}
    1. Kumru S, Yildiz FM, Godekmerdan A, Kutlu S, Yilmaz B, Gurates B. Effects of raloxifene and hormone replacement therapy on serum Th2 and Th3 type cytokine concentrations in healthy postmenopausal women: a randomised controlled trial. Archives of Gynecology and Obstetrics 2008;277(6):489-93. [PMID: ] - PubMed
L'Hermite 2022 {published data only}
    1. Ermitaño M. BIJUVA®, the only bioidentical HRT, combining estradiol and progesterone in a single pill: finally available in Belgium, after the USA (approval in 2018 by the Food and Drug Administration) ! [BIJUVA®, le seul THS bioidentique, combinant estradiol et progestérone dans une seule pilule: enfin disponible en Belgique, après les EU (approbation en 2018 par la Food and Drug Administration)]. Association des Médecins anciens étudiants de l’Université libre de Bruxelles (A.M.U.B.) 2022 2022;43(3):244-7. [DOI: 10.30637/2022.22-042] - DOI
Lin 2011 {published data only}
    1. Lin SQ, Sun LZ, Lin JF, Yang X, Zhang LJ, Qiao J, et al. Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women. Climacteric 2011;14(4):472-81. [PMID: ] - PubMed
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    1. Lindsay R, Gallagher JC, Kleerekoper M, Pickar JH. Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women. JAMA 2002;287(20):2668-76. [PMID: ] - PubMed
Liu 2012 {published data only}
    1. Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstetrics and Gynecology 2012;119(1):78-84. [PMID: ] - PubMed
Lobo 2009 {published data only}
    1. Lobo RA, Pinkerton JV, Gass ML, Dorin MH, Ronkin S, Pickar JH, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertility and Sterility 2009;92(3):1025-38. [PMID: ] - PubMed
Lobo 2017 {published data only}
    1. Lobo RA, Archer DF, Kagan R, Kaunitz AM, Constantine GD, Pickar JH, et al. A 17β-Estradiol–Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal WomenA Randomized Controlled Trial. Obstetrics & Gynecology 2018;132(1):161-70. [DOI: 10.1097/AOG.0000000000002645] - DOI - PubMed
MacDonald 1994 {published data only}
    1. MacDonald AG, Murphy EA, Capell HA, Bankowska UZ, Ralston SH. Effects of hormone replacement therapy in rheumatoid arthritis: a double blind placebo-controlled study. Annals of the Rheumatic Diseases 1994;53(1):54-7. [PMID: ] - PMC - PubMed
Marschalek 2022 {published data only}
    1. Marschalek ML, Bodner K, Kimberger O, Morgenbesser R, Dietrich W, Obruca C, et al. Sexual function in postmenopausal women with symptomatic pelvic organ prolapse treated either with locally applied estrogen or placebo: results of a double-masked, placebo-controlled, multicenter trial. Journal of Sexual Medicine 2022;19(7):1124-30. [DOI: 10.1016/j.jsxm.2022.04.007] - DOI - PubMed
Marsden 2000 {published data only}
    1. Marsden J, Whitehead M, A'Hern R, Baum M, Sacks N. Are randomized trials of hormone replacement therapy in symptomatic women with breast cancer feasible? Fertility and Sterility 2000;73(2):292-9. [PMID: ] - PubMed
Marx 2004 {published data only}
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Miller 2019 {published data only}
    1. Miller VM, Naftolin F, Asthana S, Black D, Brinton E, Bufoff M, et al. The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned? Menopause 2019;26(9):1071. [PMID: ] - PMC - PubMed
Mittal 2020 {published data only}
    1. Mittal M, Panay N, Supramaniam PR, Savvas M, Cardozo L, Hamoda H. Direct comparison of women's perceptions and acceptability of micronised progesterone and medroxyprogesterone acetate in combination with transdermal oestradiol in the management of young postmenopausal women, under 45 years of age. Post Reproductive Health 2020 ;26(4):210-19. [PMID: ] - PubMed
Mizunuma 2011 {published data only}
    1. Mizunuma H. Clinical usefulness of a low-dose maintenance therapy with transdermal estradiol gel in Japanese women with estrogen deficiency symptoms. Climacteric 2011;14(5):581-9. [PMID: ] - PubMed
Naessen 2001 {published data only}
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NCT01543399 {published data only}
    1. NCT01543399. Vascular effect of tibolone in the brachial artery (TDILA) [Vascular effect of tibolone versus placebo evaluated by flow-mediated dilatation of brachial artery]. https://clinicaltrials.gov/ct2/show/NCT01543399 (first posted 12 March 2012). [NCT: 01543399] [NCT01543399]
NCT01585558 {published data only}NCT01585558
    1. NCT01585558. Long-term safety of 30 mg and 60 mg oral daily dose of ospemifene in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women with intact uterus [Long-term safety of 30 mg and 60 mg oral daily dose of ospemifene in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women with intact uterus: a 40 week randomized, double blind, placebo controlled, follow-up to protocol 15-50310.]. https://clinicaltrials.gov/ct2/show/NCT01585558 (first posted 26 April 2012). [CTG: ]
NCT01779947 {published data only}
    1. NCT01779947. Study to evaluate the safety and bioequivalence of estradiol vaginal inserts, 10 mcg and Vagifem® 10 mcg and compare to placebo [An investigator-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of estradiol vaginal inserts, USP 10 mcg and Vagifem® (estradiol vaginal tablets) 10 mcg and compare both active treatments to a placebo control in female subjects with moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause]. https://clinicaltrials.gov/ct2/show/NCT01779947 (first posted 30 January 2013). [NCT: 01779947]
NCT01822288 {published data only}20180219001
    1. NCT01822288. The impact of hormone therapy on lower urinary tract symptoms, sexual function and psychosomatic disorder [The impact of different hormone therapy regimens on lower urinary tract symptoms, sexual function and psychosomatic disorder]. clinicaltrials.gov/ct2/show/NCT01822288 (first received 2 April 2013). [NCT01822288]
NCT02253173 {published data only}
    1. NCT02253173. Estradiol vaginal softgel capsules in treating symptoms of vulvar and vaginal atrophy in postmenopausal women (REJOICE) [A phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TX-004HR in postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy]. https://clinicaltrials.gov/ct2/show/NCT02253173 (first posted 1 October 2014). [CTG: ]
NCT02638337 {published data only}
    1. NCT02638337. Study to evaluate ospemifene in patients with moderate to severe vaginal dryness due to menopause [A phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of ospemifene in patients with moderate to severe vaginal dryness, a symptom of vulvo-vaginal atrophy (VVA) due to menopause]. https://clinicaltrials.gov/ct2/show/NCT02638337 (first posted 23 December 2015). [CTG: ]
NCT03018106 {published data only}
    1. NCT03018106. Ospemifene vs. conjugated estrogens in the treatment of postmenopausal sexual dysfunction [Ospemifene versus conjugated estrogens in the treatment of postmenopausal sexual dysfunction]. https://clinicaltrials.gov/ct2/show/NCT03018106 (first posted 11 January 2017). [CTG: ]
Nevinny‐Stickel 1983 {published data only}
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    1. Nieto C, Ferrer J, Castellanos E, Casanova A, De La Calle M, Delgado JL, et al. Efficacy of an ultra low dose estriol vaginal gel in treating postmenopausal women with vaginal dryness as their most bothersome symptom. Climacteric 2011;14:166.
Noguchi 2018 {published data only}
    1. Noguchi S, Ellis M J, Robertson JF, Thirlwell J, Fazal M, Shao Z. Progression-free survival results in postmenopausal Asian women: subgroup analysis from a phase III randomized trial of fulvestrant 500 mg vs anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON). Breast Cancer 2018;25:356-64. - PubMed
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    1. Obel EB, Munk-Jensen N, Svenstrup B, Bennett P, Micic S, Henrik-Nielsen R, et al. A two-year double-blind controlled study of the clinical effect of combined and sequential postmenopausal replacement therapy and steroid metabolism during treatment. Maturitas 1993;16(1):13-21. [PMID: ] - PubMed
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    1. Palacios S, Castelo-Branco C, Cancelo M J, Vazquez F. Low-dose, vaginally administered estrogens may enhance local benefits of systemic therapy in the treatment of urogenital atrophy in postmenopausal women on hormone therapy. Maturitas 2005;50(2):98-104. [PMID: ] - PubMed
Paraiso 2020 {published data only}
    1. Paraiso M, Ferrando C, Sokol E, Rardin C, Matthews C, Karram M, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause 2020;27(1):50-6. [PMID: ] - PubMed
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    1. Portman D, Palacios S, Nappi RE, Mueck AO. Ospemifene, a non-oestrogen selective oestrogen receptor modulator for the treatment of vaginal dryness associated with postmenopausal vulvar and vaginal atrophy: a randomised, placebo-controlled, phase III trial. Maturitas 2014;78:91-8. - PubMed
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Prestwood 2003 {published data only}
    1. Prestwood KM, Kenny AM, Kleppinger A, Kulldorff M. Ultralow-dose micronized 17beta-estradiol and bone density and bone metabolism in older women: a randomized controlled trial. JAMA 2003;290(8):1042-8. [PMID: ] - PubMed
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    1. RBR-94dx93/1. Evaluation of the sexual function and vaginal environment of menopausal women before and after treatment [Evaluation of the sexual function and vaginal microbiota fractionated microablative radiofrequency for the treatment of genitourinary menopause syndrome]. https://ensaiosclinicos.gov.br/rg/RBR-94dx93/1 (registered 7 February 2018). [REBEC: RBR-94dx93]
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    1. Rebar RW, Trabal J, Mortola J. Low-dose esterified estrogens (0.3 mg/day): long-term and short-term effects on menopausal symptoms and quality of life in postmenopausal women. Climacteric 2000;3(3):176-82. [PMID: ] - PubMed
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    1. Saeideh Z, Raziyeh M, Soghrat F. Comparing the effects of continuous hormone replacement therapy and tibolone on the genital tract of menopausal women; a randomized controlled trial. Journal of Reproduction & Infertility 2010;11(3):183-7. - PMC - PubMed
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    1. Samaras K, Hayward CS, Sullivan D, Kelly RP, Campbell LV. Effects of postmenopausal hormone replacement therapy on central abdominal fat, glycemic control, lipid metabolism, and vascular factors in type 2 diabetes. Diabetes Care 1999;22(9):1401-7. [PMID: ] - PubMed
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    1. Santoro N, Naftolin F, Black DM, Brinton EA, Budoff MJ, Cedars MI, et al. Change over time in menopausal symptoms in women randomized to oral conjugated estrogen or transdermal estradiol plus micronized progesterone versus placebo: the kronos early estrogen prevention study (KEEPS). Menopause 2012;19:1403-4. - PMC - PubMed
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    1. Sarebani Z, Alimoradi Z, Aali E, Mirzadeh M, Chegini V, Abbaspour M, et al. Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women: study protocol for a randomized controlled trial. BMC Womens Health 2020;20(1):27. - PMC - PubMed
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    1. Shah S, Bell RJ, Savage G, Goldstat R, Papalia MA, Kulkarni J, et al. Testosterone aromatization and cognition in women: a randomized, placebo-controlled trial. Menopause 2006;13(4):600-8. [PMID: ] - PubMed
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    1. Silverman SL, Chines AA, Kendler DL, Kung AW, Teglbjærg CS, Felsenberg D, et al. Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study. Osteoporosis International 2012;23(1):351-63. [PMID: ] - PubMed
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Simon 2008a {published data only}
    1. Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstetrics and Gynecology 2008;112(5):1053-60. [PMID: ] - PubMed
Simon 2008b {published data only}
    1. Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertility and Sterility 2008;90(4):1132-8. [PMID: ] - PubMed
Simon 2012 {published data only}
    1. Simon JA, Lin VH, Radovich C, Bachmann GA, The Ospemifene Study Group. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause 2012;20(4):418-27. [PMID: ] - PubMed
Simunic 2003 {published data only}
    1. Simunic V, Banovic I, Ciglar S, Jeren L, Pavicic Baldani D, Sprem M. Local estrogen treatment in patients with urogenital symptoms. International Federation of Gynaecology and Obstetrics 2003;82(2):187-97. [PMID: ] - PubMed
SMART‐5 {published data only}
    1. Archer DF, Lobo RA, Pan K, Chines AA, Mirkin S. Safety and tolerability of bazedoxifene/conjugated estrogens in postmenopausal women: findings from a 1-year, randomized, placebo-and active-controlled, phase 3 trial. Menopause 2011;18:1355-6.
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Sorensen 2001 {published data only}
    1. Sorensen MB, Rosenfalck AM, Hojgaard L, Ottesen B. Obesity and sarcopenia after menopause are reversed by sex hormone replacement therapy. Obesity Research 2001;9(10):622-6. [PMID: ] - PubMed
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    1. Speroff L, Haney AF, Gilbert RD, Ellman H, Estradiol Acetate Investigator Group. Efficacy of a new, oral estradiol acetate formulation for relief of menopause symptoms. Menopause 2006;13(3):442-50. [PMID: ] - PubMed
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    1. Stening KD, Eriksson O, Henriksson KG, Brynhildsen J, Lindh-Åstrand L, Berg G, et al. Hormonal replacement therapy does not affect self-estimated pain or experimental pain responses in post-menopausal women suffering from fibromyalgia: a double-blind, randomized, placebo-controlled trial. Rheumatology 2011;50(3):544-51. [PMID: ] - PubMed
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    1. Stevenson JC, Durand G, Kahler E, Pertynski T. Oral ultra-low dose continuous combined hormone replacement therapy with 0.5 mg 17beta-oestradiol and 2.5 mg dydrogesterone for the treatment of vasomotor symptoms: results from a double-blind, controlled study. Maturitas 2010;67(3):227-32. [PMID: ] - PubMed
Sun 2016 {published data only}
    1. Sun Z, Zhu L, Xu T, Shi X, Lang J. Effects of preoperative vaginal estrogen therapy for the incidence of mesh complication after pelvic organ prolapse surgery in postmenopausal women: is it helpful or a myth? A 1-year randomized controlled trial. Menopause 2016;23(7):740–8. [PMID: ] - PubMed
Swanson 2006 {published data only}
    1. Swanson SG, Drosman S, Helmond FA, Stathopoulos VM. Tibolone for the treatment of moderate to severe vasomotor symptoms and genital atrophy in postmenopausal women: a multicenter, randomized, double-blind, placebo-controlled study. Menopause 2006;13(6):917-25. [PMID: ] - PubMed
Tansupswatdikul 2012 {published data only}
    1. Tansupswatdikul P, Chaikiltisilpa S, Jaimchariyatam N, Desudchit T, Panyakhamlerd K, Jaisamrarn U, et al. Effect of estrogen therapy on objective sleep quality in postmenopausal women. Menopause (New York, N.Y.) 2012;19:1384-5.
Tinelli 2002 {published data only}
    1. Tinelli FG, Tinelli A, Sena T. Clinical effects of hormone replacement therapy with estradiol valerate and cyproterone acetate in perimenopausal women [Effetti di un trattamento ormonale sostitutivocon estradiolo valerato e ciproterone acetatoin donne in perimenopausa]. Minerva Ginecologica 2002;54(1):67-73. [PMID: ] - PubMed
Tungmunsakulchai 2015 {published data only}
    1. Tungmunsakulchai R, Chaikittisilpa S, Snabboon T, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women. BMC Women's Health 2015;2(15):113. - PMC - PubMed
Tuomikoski 2010 {published data only}
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Usall 2011 {published data only}
    1. Usall J, Huerta-Ramos E, Iniesta R, Cobo J, Araya S, Roca M, et al. Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. Journal of Clinical Psychiatry 2011;72(11):1552-7. [PMID: ] - PubMed
Utian 2001 {published data only}
    1. Utian WH, Shoupe D, Bachmann G, Pinkerton JV, Pickar JH. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertililty and Sterility 2001;75(6):1065-79. [PMID: ] - PubMed
Utian 2004 {published data only}
    1. Utian WH, Gass ML, Pickar JH. Body mass index does not influence response to treatment, nor does body weight change with lower doses of conjugated estrogens and medroxyprogesterone acetate in early postmenopausal women. Menopause 2004;11(3):306-14. [PMID: ] - PubMed
Vardy 2003 {published data only}
    1. Vardy MD, Lindsay R, Scotti RJ, Mikhail M, Richart RM, Nieves J, et al. Short-term urogenital effects of raloxifene, tamoxifen, and estrogen. American Journal of Obstetrics and Gynecology 2003;189(1):81-8. [PMID: ] - PubMed
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Vestergaard 2003 {published data only}
    1. Vestergaard P, Hermann AP, Stilgren L, Tofteng CL, Sørensen OH, Eiken P, et al. Effects of 5 years of hormonal replacement therapy on menopausal symptoms and blood pressure - a randomised controlled study. Maturitas 2003;46(2):123-32. [PMID: ] - PubMed
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    1. Woo J, Lau E, Ho SC, Cheng F, Chan C, Chan AS, et al. Comparison of Pueraria lobata with hormone replacement therapy in treating the adverse health consequences of menopause. Menopause 2003;10(4):352-61. [PMID: ] - PubMed
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    1. Yeo W, Pang E, Liem GS, Suen JJ, Ng RY, Yip CC, et al. Menopausal symptoms in relationship to breast cancer-specific quality of life after adjuvant cytotoxic treatment in young breast cancer survivors. Health and Quality of Life Outcomes 2020;18(24):24. - PMC - PubMed
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    1. Zervoudis S, Iatrakis G, Peitsidis P, Tsikouras P, Galazios G, Liberis V, et al. Tibolone vaginal versus per os administration in the management of post-menopausal symptoms. Revista Medico-Chirurgicala a Societatii de Medici si Naturalisti din Iasi 2009;113(2):471-7. [PMID: ] - PubMed
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    1. Zhou YZ, Sun LZ, Lin JF, Yang X, Zhang LJ, Qiao J, et al. Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women: a randomized, multi-center, double-blind, placebo-controlled clinical study. Zhonghua Fu Chan Ke Za Zhi 2011;46(5):345-9. [PMID: ] - PubMed
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    1. Zullo MA, Plotti F, Calcagno M, Palaia I, Muzii L, Manci N, et al. Vaginal estrogen therapy and overactive bladder symptoms in postmenopausal patients after a tension-free vaginal tape procedure: a randomized clinical trial. Menopause 2005;12(4):421-7. [PMID: ] - PubMed

References to studies awaiting assessment

Hirschberg 2020 {published data only}
    1. Hirschberg AL, Sánchez-Rovira P, Presa-Lorite J, Campos-Delgado M, Gil-Gil M, Lidbrink E, et al. Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-contr. Menopause 2020;27(5):526-34. [DOI: 10.1097/GME.0000000000001497] [PMID: ] - DOI - PMC - PubMed
NCT01845649 {published data only}
    1. NCT01845649. Study to evaluate safety & efficacy of WC3011 in postmenopausal women with dyspareunia [A randomized, multicenter, double-blind, vehicle-controlled study to evaluate the safety and efficacy of WC3011 in postmenopausal women with dyspareunia]. https://www.clinicaltrials.gov/ct2/show/NCT01845649 (first posted 3 May 2013). [NCT: 01845649]
NCT02460302 {published data only}
    1. NCT02460302. Vaginal progesterone versus placebo for the treatment of vaginal atrophy [Vaginal progesterone versus placebo for the treatment of vaginal atrophy - a double blind randomized control trial]. https://clinicaltrials.gov/ct2/show/NCT02460302 (first posted 2 June 2015). [CTG: ]
NCT02834312 {published data only}
    1. NCT02834312. E4Relief (response to estetrol in life Improvement for menopausal-associated hot flushes) [A multicentre dose-finding, randomised, double-blind, placebo-controlled study to select the daily oral dose of estetrol (E4) for the treatment of vasomotor symptoms in post-menopausal women]. https://clinicaltrials.gov/ct2/show/NCT02834312 (first posted 15 July 2016). [NCT: 02834312]
NCT03363997 {published data only}
    1. NCT03363997. Pharmacokinetics and pharmacodynamics of 3 dosages of estriol after continuous vaginal administration for 21 days [A randomized, open-label trial to evaluate the pharmacokinetics and pharmacodynamics of 3 dosages of estriol after continuous vaginal administration for 21 days in healthy, post-menopausal women]. https://clinicaltrials.gov/ct2/show/NCT03363997 (first posted 6 December 2017). [CTG: ]
Pinkerton 2017 {published data only}
    1. Pinkerton JV, Bushmakin AG, Bobula J, Lavenberg J, Komm BS, Abraham L. Time to first occurrence of breast pain and vaginal bleeding in phase 3 trials of CE/BZA. Menopause 2017;24:1372-7. - PubMed
Tanmahasamut 2020 {published data only}
    1. Tanmahasamut P, Jirasawas T, Laiwejpithaya S, Areeswate C, Dangrat C, Silprasit K. Effect of estradiol vaginal gel on vaginal atrophy in postmenopausal women: a randomized double-blind controlled trial. Journal of Obstetrics and Gynaecology Research 2020;46(8):1425-35. [DOI: 10.1111/jog.14336] [PMID: ] - DOI - PubMed

References to ongoing studies

NCT02668796 {published data only}
    1. NCT02668796. To study generic estradiol 10 mcg vaginal tablets in the treatment of vulvar and vaginal atrophy in post menopausal women. clinicaltrials.gov/ct2/show/NCT02668796 (first received 29 January 2016). [NCT02668796]
NCT02670785 {published data only}
    1. NCT02670785. A safety and efficacy study of estradiol vaginal capsule in postmenopausal women with vulvovaginal atrophy. clinicaltrials.gov/ct2/show/NCT02670785 (first received 2 February 2016). [NCT02670785]
NCT02859285 {published data only}
    1. NCT01822288. The impact of hormone therapy on lower urinary tract symptoms, sexual function and psychosomatic disorderA Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women. clinicaltrials.gov/ct2/show/NCT01822288 (first received 2 April 2013). [NCT01822288]
NCT03116022 {published and unpublished data}
    1. NCT03116022. Use of estriol at distal third of vagina improving coital pain in post-menopause women. clinicaltrials.gov/ct2/show/NCT03116022 (first received 14 April 2017). [NCT03116022.]

Additional references

Alexander 2004
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Ali 2020
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