MedTrace Logo

Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial

NCT07260825 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-03

No results posted yet for this study

Summary

We are looking to see if patients using both topical testosterone and estrogen will have a greater improvement in pain with vaginal penetration compared to those using topical estrogen alone.

Conditions

  • Vulvodynia
  • Dyspareunia
  • Lichen Sclerosus of Vulva

Interventions

DRUG

Estradiol 0.01% Vag Cream

0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks

DRUG

testosterone 0.1% and estradiol 0.01% vaginal cream

0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07260825 on ClinicalTrials.gov