The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy

Launched by OXAGON · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new gel containing oxytocin, which is applied to the vagina, to see if it helps relieve symptoms of vaginal atrophy in postmenopausal women. Vaginal atrophy is a condition that can cause dryness, discomfort, and other problems in the vaginal area due to hormonal changes after menopause. The trial aims to find out if this gel is safe and effective for women who are experiencing bothersome symptoms related to this condition.

To join the study, women need to be between 47 and 65 years old, have been through menopause, and be sexually active. They should also show signs of vaginal atrophy and have at least one symptom that is bothering them. Participants will be asked to avoid certain treatments and activities before the trial starts, and they will receive either the oxytocin gel or a placebo (a gel that doesn’t contain the active ingredient) without knowing which one they are using. Throughout the trial, participants can expect regular check-ins to monitor their symptoms and overall health. This research could provide new options for women seeking relief from vaginal atrophy symptoms.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
• • 2. 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.
• • 4. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \> 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) \> 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits
• Exclusion Criteria:
• • 1. Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
• • 2. Women taking systemic hormone replacement or pills within the last 6 months.
• • 3. Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
• • 4. Any untreated urogenital infection within 14 days prior to randomization.
• • 5. 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.
• • 6. Critically ill patients.
• • 7. Patients with severe renal impairment (GFR \< 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
• • 8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.
• • 9. Patients with known or suspected allergy or any contraindications to oxytocin.