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

NCT05627791 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Vaginal Atrophy
  • Oxytocin Gel
  • Postmenopausal Women
  • Vaginal Maturation Index

Interventions

DRUG

Oxytocin

Oxytocin vaginal gel that have oxytocin 400IU/1ml of gel, base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0

DRUG

Placebo

Placebo gel that have base gel contained HPMC 4,000 cps, 5% propylene glycol USP, 0.08% methylparaben, sterile water for irrigation and 0.02% propylparaben then adjusted pH by Lactic acid and sodium hydroxide keep pH 3.5-4.0 without oxytocin

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-07-31
Completion
2023-08-28

Countries

  • Thailand

Study Locations

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Entities

Drugs

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 NCT05627791 on ClinicalTrials.gov