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

NCT ID: NCT07260825

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-08-31

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.

Detailed Description

You are being asked to take part in this research study because you have vulvodynia. Vulvodynia refers to pain in the female vestibule. The vestibule is the area that encircles the vaginal opening and the urethra opening. One of the symptoms of vulvodynia is pain with intercourse.

The purpose of this research study is to determine if using estrogen cream versus a combined cream with estrogen and testosterone helps decrease your pain with intercourse.

Multiple studies have been conducted looking at the use of combined cream with estrogen and testosterone to treat vulvodynia. However, none of the studies have compared this to using estrogen cream alone. It is well known that estrogen cream applied to the vagina helps reduce symptoms of vulvodynia. Combined creams with estrogen and testosterone have been shown to help patients who have vulvodynia and are taking birth control pills.

In 2016, the FDA approved a vaginal cream, known as DHEA, to help women with painful intercourse. This is a substance that once applied to the vagina, turns into a mixture of estrogen and testosterone. We know from prior research that the vestibule area is rich in testosterone receptors, so it makes sense that DHEA cream applied vaginally would be able to help vulvodynia patients. However, we do not know the ratio of the breakdown of estrogen versus testosterone from the DHEA substance.

Testosterone applied to the vagina has been shown to improve symptoms in patients with other vulvar conditions, such as lichen sclerosus. Lichen sclerosus is a chronic skin condition that primarily affects the genital area, but it can also affect other areas of the body. It is characterized by white, thickened patches of skin that may be itchy, sore, or painful.

Although topical DHEA was FDA approved for use in women with painful intercourse in 2016, topical testosterone combined with estrogen is not FDA approved for use in women, which means it is investigational. However, it is becoming more common as a treatment option for patients with vulvodynia, and its safety and effectiveness in women has been demonstrated in other studies.

Conditions

Vulvodynia; Dyspareunia; Lichen Sclerosus of Vulva

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard of care

Patients receiving standard of care

Group Type: ACTIVE_COMPARATOR

Estradiol 0.01% Vag Cream

Intervention Type: DRUG

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

Treatment

Patients receiving study treatment

Group Type: EXPERIMENTAL

testosterone 0.1% and estradiol 0.01% vaginal cream

Intervention Type: DRUG

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

Interventions

Estradiol 0.01% Vag Cream

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

TriHealth

Cincinnati, Ohio, United States

Countries

United States

Central Contacts

Gisele Moran, MD, MPH

Role: CONTACT

gisele_moran@trihealth.com

513-463-4300

Facility Contacts

Jennifer Hodge, RN

Role: primary

Jennifer_hodge2@trihealth.com

513-463-4300

Other Identifiers

25-108

Identifier Type: -

Identifier Source: org_study_id