NCT05627791

Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

Terminated Phase 2, PHASE3 Last updated 31 August 2023

What this trial tests

Phase 2, PHASE3 trial testing Oxytocin in Vaginal Atrophy in 6 participants. Terminated before completion.

Timeline

30 November 2022

Primary endpoint
31 July 2023

28 August 2023

Quick facts

Lead sponsor	Department of Medical Services Ministry of Public Health of Thailand
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	6
Start date	30 November 2022
Primary completion	31 July 2023
Estimated completion	28 August 2023
Sites	1 location across Thailand

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →
• Placebo

Conditions studied

• Vaginal Atrophy — all drugs for Vaginal Atrophy →
• Oxytocin Gel — all drugs for Oxytocin Gel →
• Postmenopausal Women — all drugs for Postmenopausal Women →
• Vaginal Maturation Index — all drugs for Vaginal Maturation Index →

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Who can join

Adults 50 to 70, female only, with Vaginal Atrophy or Oxytocin Gel. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.