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. 2022 Aug;28(2):60-69.
doi: 10.6118/jmm.21038.

Early Effect of 0.005% Estriol Vaginal Gel on Symptoms and Signs of Vulvovaginal Atrophy

Jesús Lázaro-Carrasco de la Fuente  1 , Marcos Cuerva González  2 , Silvia González Rodríguez  3 , Juan Luis Delgado Marín  4 , Carmen Cuevas Castillo  5 , Concepción Nieto Magro  5
Affiliations

Early Effect of 0.005% Estriol Vaginal Gel on Symptoms and Signs of Vulvovaginal Atrophy

Jesús Lázaro-Carrasco de la Fuente et al. J Menopausal Med. 2022 Aug.

Abstract

Objectives: This study aims to assess the effect of ultralow dose 0.005% estriol vaginal gel in women with genitourinary syndrome of menopause (GSM).

Methods: In this prospective and multicenter single-arm study, efficacy was assessed by the evaluation of the epithelial maturation value (MV), vaginal pH, symptoms and signs of vulvovaginal atrophy. Tolerability, acceptability, and the effect on intimate relationships were also evaluated.

Results: We included 35 postmenopausal women with moderate-to-severe vaginal dryness. The most bothering symptom reported was vaginal dryness. The mean increase in the MV after 7 and 14 days of treatment were 22.1 (P < 0.001) and 39.9 (P < 0.001) points, with an increase in the superficial cells of 17.7 percentage points (pp) (95% confidence interval [CI], 7.9-27.4; P < 0.001) and 41.4 pp (95% CI, 28.2-54.6; P < 0.001) observed at the timepoints. Additionally, the pH decreased by 0.6 ± 0.7 (mean ± SD) at 7 days (P < 0.0001) and by 1.1± 0.8 at 14 days (P < 0.0001) from a baseline mean value of 6.3 ± 0.8. The severity of vaginal dryness (range, 0 [none] to 3 [severe]) was significantly reduced by a mean of 1.4 points (P < 0.0001) at 7 days and 2 points (P < 0.0001) at 14 days.

Conclusions: Ultralow dose 0.005% estriol vaginal gel produced a rapid improvement of most relevant symptoms and signs of GSM. This clinically meaningful response was observed from the initial days of treatment, confirming a fast onset and a progressive action.

Keywords: Atrophy; Estriol; Gels; Postmenopause; Vagina.

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Conflict of interest statement

J.L.-C.F., M.C.G., and J.L.D.M. report no conflicts of interest. S.G.R. reports grants for research activities, for attending conferences, as a consultant, and/or for lecturing in scientific meetings from Isdin, Pfizer, Servier, Amgen, MSD, Kern, Casen-Recordati, Sandoz, Procare Health, Bayer, Lacer, Shionogi, GSK, Bioiberica, Theramex, Gedeon Ritcher, Effik, Italfarmaco, Iprad, Seid, Ordesa, and Zambon. C.C.C. and C.N.M. are full time employees of ITF Research Pharma.

Figures

Fig. 1
Fig. 1. Mean vaginal maturation value (± SD) at baseline, day 7 and day 14. P values were obtained by comparing with baseline. aP < 0.0001, Student’s t test for paired samples and clinically relevant > 15 points.
Fig. 2
Fig. 2. Mean values (± SD) at all time intervals in (A) percentage of superficial, intermediate and parabasal cells and (B) vaginal pH. P values were obtained by comparing with baseline. aP < 0.0001, Wilcoxon test. bP = 0.0161, Student’s t test. cP = 0.0467, Student’s t test. dP = 0.0002, Wilcoxon test.
Fig. 3
Fig. 3. Proportion of patients at baseline, day 7 and day 14 reporting to have none, mild, moderate or severe symptomatology in the following symptoms: (A) vaginal dryness, (B) dyspareunia or discomfort during intercourse, (C) pruritus, stinging or burning of the vulva or vagina, and (D) lack of lubrication.
Fig. 4
Fig. 4. Daily evolution (mean ± SD) of the self-assessed severity of the symptomatology. (A) Vaginal drynes, (B) dyspareunia or discomfort with sexual activity, (C) pruritus, stinging or burning of the vulva or vagina, and (D) lack of lubrication. Intensity of each symptoms was assessed and reported by patients according to a 4-point Likert scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). P values were obtained by comparing with baseline. aP < 0.05, Student’s t test for paired samples.
Fig. 5
Fig. 5. Mean change from baseline in the total score of (A) symptoms and (B) signs at days 7 and 14. P values were obtained by comparing with baseline. aP < 0.05, Student’s t test for paired samples.
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