The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy (NCT06514586) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy
Egypt244 participantsStarted 2024-09
Plain-language summary
A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.
Who can participate
Age range47 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
✓. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.
Exclusion criteria
✕. Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
✕. Women taking systemic hormone replacement or pills within the last 6 months.
✕. Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
✕. Any untreated urogenital infection within 14 days prior to randomization.
✕. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
✕. Critically ill patients.
✕. Patients with severe renal impairment (GFR \< 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
What they're measuring
1
The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment.
Timeframe: 60 days
2
The mean change from the baseline to Day 60 of the vaginal pH
Timeframe: 60 days
3
The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI)