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

TriHealth

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Dyspareunia; Lichen Sclerosus of Vulva; Vulvodynia

Treatments: Drug: testosterone 0.1% and estradiol 0.01% vaginal cream; Drug: Estradiol 0.01% Vag Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07260825

25-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Patients receiving standard of care

Treatment:

Drug: Estradiol 0.01% Vag Cream

Treatment

Experimental group

Description:

Patients receiving study treatment

Treatment:

Drug: testosterone 0.1% and estradiol 0.01% vaginal cream