Topical Testosterone and Estrogen for Vulvodynia

This study is looking at how well two different creams work to reduce pain during vaginal penetration for women with vulvodynia (pain in the female vestibule, the area around the vaginal opening). We want to see if using a cream with both testosterone 0.1% and estradiol 0.01% is better than using estradiol 0.01% cream alone. You might be able to join if you are 18 or older, have vulvodynia with pain during vaginal penetration that rates 4 or higher, and are not pregnant or breastfeeding. We are looking for 44 participants. The main goal is to measure your typical pain with vaginal penetration after 12 weeks of treatment. The current recruitment status is unclear.

Study design
This is an interventional study comparing two different topical creams. It plans to enroll 44 women.
What's involved
You would apply 1 gram of cream to the vestibule twice daily for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at 12 weeks post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07260825

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
TriHealth Inc.
~44 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:Estradiol 0.01% Vag Creamtestosterone 0.1% and estradiol 0.01% vaginal cream

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Typical pain with vaginal penetration within last 2 weeks
Measured over at 12 weeks post-treatment
Vulvodynia
Dyspareunia
Lichen Sclerosus of Vulva

NCT07260825

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cincinnati Urogynecology Associates

    Cincinnati, Ohiostudy coordinator listed

  • TriHealth

    Cincinnati, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

18 years or older
Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater

Exclusion

Active vaginal infection
Pregnancy
Breast-feeding
Taking anti-androgenic medication (finasteride, dutasteride)
Using any other topical hormones to the vulva or vagina
  • Typical pain with vaginal penetration within last 2 weeksat 12 weeks post-treatment

    Typical pain with vaginal penetration within last 2 weeks using numeric rating scale