Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Jun 21:9:88.
doi: 10.1186/1477-7827-9-88.

Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: a randomized controlled trial

Simone Ferrero  1 , Pier L Venturini, David J Gillott, Valentino Remorgida
Affiliations
Randomized Controlled Trial

Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: a randomized controlled trial

Simone Ferrero et al. Reprod Biol Endocrinol. .

Abstract

Background: When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.

Methods: Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.

Results: A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p=0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p=0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p=0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.

Conclusions: Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow chart showing recruitment and women's progress through the study.
See this image and copyright information in PMC

References

    1. Ferrero S, Venturini PL, Ragni N, Camerini G, Remorgida V. Pharmacological treatment of endometriosis: experience with aromatase inhibitors. Drugs. 2009;69:943–952. doi: 10.2165/00003495-200969080-00001. - DOI - PubMed
    1. De Ziegler D, Mattenberger C, Luyet C, Romoscanu I, Irion NF, Bianchi-Demicheli F. Clinical use of aromatase inhibitors (AI) in premenopausal women. J Steroid Biochem Mol Biol. 2005;95:121–127. doi: 10.1016/j.jsbmb.2005.04.023. - DOI - PubMed
    1. Remorgida V, Abbamonte LH, Ragni N, Fulcheri E, Ferrero S. Letrozole and desogestrel-only contraceptive pill for the treatment of stage IV endometriosis. Aust N Z J Obstet Gynaecol. 2007;47:222–225. doi: 10.1111/j.1479-828X.2007.00722.x. - DOI - PubMed
    1. Gurates B, Parmaksiz C, Kilic G, Celik H, Kumru S, Simsek M. Treatment of symptomatic uterine leiomyoma with letrozole. Reprod Biomed Online. 2008;17:569–574. doi: 10.1016/S1472-6483(10)60246-5. - DOI - PubMed
    1. Alborzi S, Hamedi B, Omidvar A, Dehbashi S, Alborzi S, Alborzi M. A comparison of the effect of short-term aromatase inhibitor (letrozole) and GnRH agonist (triptorelin) versus case control on pregnancy rate and symptom and sign recurrence after laparoscopic treatment of endometriosis. Arch Gynecol Obstet. 2010. in press . - PubMed

Publication types

MeSH terms