Loading clinical trials...

The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE3

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

The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial

NCT06514586•Oxagon

View on ClinicalTrials.gov

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.

Detailed Description

A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.

Eligibility

Age

47 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (1)

Oxagon

Cairo, Egypt

Key Dates

Start Date

September 1, 2024

Primary Completion Date

June 1, 2025

Completion Date

August 1, 2025

Last Updated

July 23, 2024

Enrollment

244

ESTIMATED participants

Conditions

Vaginal AtrophyGenitourinary Syndrome of MenopauseVulvar Atrophy

Interventions

Oxytocin

DRUG

Hydroxypropyl methylcellulose

OTHER

Contacts

Ibrahim Gado

CONTACT

00201094742244 ibrahim.gado@oxagon-ab.com

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

NCT06900374

Vaginal DrynessBreast Cancer+1 more

View study

RECRUITINGNA

Vaginal Changes After CO2 Laser

NCT06691178

Genitourinary Syndrome of Menopause

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Vaginal Changes After CO2 Laser

Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy

Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women

Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomize

Vaginal Ecosystem and Network in the United States Study