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

NCT ID: NCT06514586

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-08-31

Brief 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.

Conditions

Vaginal Atrophy; Genitourinary Syndrome of Menopause; Vulvar Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MenOxy

The investigational product will contain a Plastic tube containing 36 g of study product (gel) and a Vaginal calibrated plastic applicator for dose (1 ml) administration. The active constituent is oxytocin 600 IU/ml dissolved in a gel based on Hypromellose with a pH of 3.8.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Oxytocin gel 600 IU . 1mg/g

Placebo

The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin.

Group Type: PLACEBO_COMPARATOR

Hydroxypropyl methylcellulose

Intervention Type: OTHER

Placebo

Interventions

Oxytocin

Oxytocin gel 600 IU . 1mg/g

Intervention Type: DRUG

Hydroxypropyl methylcellulose

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 47 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oxagon

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assem Anwar

Role: PRINCIPAL_INVESTIGATOR

Azhar Univeristy

Locations

Oxagon

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ibrahim Gado

Role: CONTACT

ibrahim.gado@oxagon-ab.com

00201094742244

Facility Contacts

Ibrahim Gado

Role: primary

ibrahim.gado@oxagon-ab.com

00201094742244

Khaled Prince

Role: backup

khaled.prince@clinmax.net

Other Identifiers

Oxagon

Identifier Type: -

Identifier Source: org_study_id