Dyspareunia, Lichen Sclerosus of Vulva, Vulvodynia
Conditions
Keywords
topical testosterone, estrogen cream, vulvodynia
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.
Interventions
0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks
DRUGtestosterone 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
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Typical pain with vaginal penetration within last 2 weeks | at 12 weeks post-treatment | Typical pain with vaginal penetration within last 2 weeks using numeric rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Typical pain with vaginal penetration within last 2 weeks | at 6 weeks post-treatment | Typical pain with vaginal penetration within last 2 weeks using numeric rating scale |
| Sexual function | at 6 weeks and 12 weeks post-treatment | sexual function as measured by Female Sexual Function Index |
| Most intense pain with vaginal penetration within last 2 weeks | at 6 weeks and 12 weeks post-treatment | Most intense pain with vaginal penetration within last 2 weeks using numeric rating scale |
Countries
United States
Contacts
Primary ContactGisele Moran, MD, MPH
Outcome results
None listed