Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Estradiol 0.01% Vag Cream, testosterone 0.1% and estradiol 0.01% vaginal cream.
- Who it may be relevant to
- Registry conditions: Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Typical pain with vaginal penetration within last 2 weeks [Time frame: at 12 weeks post-treatment]
Secondary outcome measures (3)
- Typical pain with vaginal penetration within last 2 weeks [Time frame: at 6 weeks post-treatment]
- Sexual function [Time frame: at 6 weeks and 12 weeks post-treatment]
- Most intense pain with vaginal penetration within last 2 weeks [Time frame: at 6 weeks and 12 weeks post-treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Cincinnati Urogynecology Associates — Cincinnati
- TriHealth — Cincinnati
Identifiers
NCT: NCT07260825 · 25-108