NCT06514586

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Oxagon · Network
• Sex: Female
• Age: 47 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Oxytocin	Oxytocin gel 600 IU . 1mg/g
OTHER	Hydroxypropyl methylcellulose	Placebo

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-06-01
• Completion: 2025-08-01
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Egypt