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

NCT07260825 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-108
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

topical testosterone; estrogen cream; vulvodynia

Outcome Measures

Primary Outcomes (1)

• Typical pain with vaginal penetration within last 2 weeks

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

  at 12 weeks post-treatment

Secondary Outcomes (3)

• Typical pain with vaginal penetration within last 2 weeks

  at 6 weeks post-treatment

• Sexual function

  at 6 weeks and 12 weeks post-treatment

• Most intense pain with vaginal penetration within last 2 weeks

  at 6 weeks and 12 weeks post-treatment

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Patients receiving standard of care

Drug: Estradiol 0.01% Vag Cream

Treatment

EXPERIMENTAL

Patients receiving study treatment

Drug: testosterone 0.1% and estradiol 0.01% vaginal cream

Interventions

Estradiol 0.01% Vag Cream DRUG

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

Standard of care

testosterone 0.1% and estradiol 0.01% vaginal cream DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active vaginal infection
• Pregnancy
• Breast-feeding
• Taking anti-androgenic medication (finasteride, dutasteride)
• Using any other topical hormones to the vulva or vagina

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (2)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

TriHealth

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Vulvodynia; Dyspareunia; Vulvar Lichen Sclerosus

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies; Testosterone

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies; Androstenols; Androstenes; Androstanes; Testosterone Congeners

Central Study Contacts

Gisele Moran, MD, MPH

CONTACT

513-463-4300; gisele_moran@trihealth.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (2)