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Effect of estradiol vaginal gel on vaginal atrophy in postmenopausal women: A randomized double‐blind controlled trial
Author(s) -
Tanmahasamut Prasong,
Jirasawas Titima,
Laiwejpithaya Somsak,
Areeswate Chatchai,
Dangrat Chongdee,
Silprasit Kittayaporn
Publication year - 2020
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/jog.14336
Subject(s) - medicine , vaginal atrophy , menopause , randomized controlled trial , gynecology , postmenopausal women , intravaginal administration , atrophy , vagina , estrogen , urology , surgery
Aim To evaluate the efficacy and safety of 25 μg of estradiol gel on postmenopausal vaginal tissue. Methods This randomized double‐blind controlled trial included postmenopausal women with vaginal atrophy who attended our menopause clinic during July 2017–January 2018. Women were randomly assigned to the estradiol gel group or control group (K‐Y® Jelly). Treatment consisted of 2 mL of product applied intravaginally daily for 2 weeks, and two doses per week for the next 6 weeks. The most bothersome symptom (MBS), vaginal health index (VHI), vaginal pH, vaginal maturation index, vaginal maturation value (VMV), female sexual function index (FSFI), serum estradiol level and endometrial thickness were evaluated at baseline, 4 and 8 weeks. Results Seventy‐five of 80 women completed the trial. After 8 weeks of treatment, VMV, VHI, vaginal pH and FSFI improved significantly in the estradiol group, with no observed change in the control group. The MBS was decreased in both groups with no significant difference between groups. Serum estradiol level and endometrial thickness were not significantly different between groups at baseline or at week 8. Conclusion Estradiol vaginal gel demonstrated an ability to reverse vaginal atrophy with a high safety profile and low systemic absorption of estradiol.