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

NCT06514586 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Vaginal Atrophy
  • Genitourinary Syndrome of Menopause
  • Vulvar Atrophy

Interventions

DRUG

Oxytocin

Oxytocin gel 600 IU . 1mg/g

OTHER

Hydroxypropyl methylcellulose

Placebo

Sponsors & Collaborators

  • Oxagon

    lead NETWORK

Principal Investigators

  • Assem Anwar · Azhar Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-06-30
Completion
2025-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514586 on ClinicalTrials.gov