A Randomized Controlled Trial of Intravaginal Estriol Gel versus Non-Hormonal Lubricant for Genitourinary Syndrome of Menopause in Postmenopausal Women

International Journal of Obstetrics and Gynecology | Vol. 14, No. 9, September 2026 | pp. 819–830

DOI: 10.46882/2026/IJOG/000549

Original Research Article

Title: A Randomized Controlled Trial of Intravaginal Estriol Gel versus Non-Hormonal Lubricant for Genitourinary Syndrome of Menopause in Postmenopausal Women

Names of Authors: Mariam T. Bello¹, Grace E. Effiong²

Authors’ Affiliations:
¹ Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University College Hospital, Ibadan, Nigeria
² Department of Public Health, University of Calabar, Calabar, Nigeria

Abstract:
Genitourinary Syndrome of Menopause (GSM) is characterized by progressive vulvovaginal mucosal atrophy, resulting in severe dyspareunia and vaginal dryness. This randomized, double-blind active-controlled trial assessed the tissue-restoring efficacy, changes in vaginal maturation index, and local safety of once-daily intravaginal 0.1% estriol gel compared to a non-hormonal polycarbophil-based vaginal lubricant. One hundred and forty postmenopausal women presenting with severe GSM symptoms were randomized into two equal cohorts (n = 70 per group) for a treatment period of 12 weeks. Primary outcomes included changes in the Vaginal Health Index (VHI) score, vaginal pH, and subjective symptom severity scores. After 12 weeks of treatment, the estriol gel cohort achieved a significantly higher mean VHI score compared to the lubricant cohort (21.5 ± 2.2 vs. 14.8 ± 1.6, p < 0.001). Mean vaginal pH dropped significantly below 4.5 in the estriol arm, whereas it remained elevated above 5.5 in the lubricant arm (p < 0.001). Subjective dyspareunia intensity dropped substantially more in the estriol group than in the lubricant group (mean reductions of 2.15 ± 0.45 vs. 0.85 ± 0.22 points, p < 0.001). Circulating hormonal monitoring confirmed that serum estradiol levels remained well within the safe postmenopausal baseline threshold (< 10 pg/mL) in both groups. Daily intravaginal estriol gel offers significantly superior mucosal tissue rejuvenation and symptomatic dyspareunia relief compared to non-hormonal lubricants without causing systemic estrogenic accumulation.

Keywords: Genitourinary Syndrome of Menopause; Estriol Gel; Vaginal Lubricant; Dyspareunia; Vaginal Health Index; Postmenopausal Health.

Manuscript Timeline: Received: July 18, 2026; Revised: August 22, 2026; Accepted: September 03, 2026; Published: September 07, 2026.

Citation: Bello MT, Effiong GE. A Randomized Controlled Trial of Intravaginal Estriol Gel versus Non-Hormonal Lubricant for Genitourinary Syndrome of Menopause in Postmenopausal Women. International Journal of Obstetrics and Gynecology. 2026; 14(9): 819–830.

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