A Phase 2/3 interventional study of Estradiol 0.01% Vag Cream and testosterone 0.1% and estradiol 0.01% vaginal cream in Vulvodynia, Dyspareunia and Lichen Sclerosus of Vulva, sponsored by TriHealth Inc.. Not yet recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by TriHealth Inc. · Phase 2/3, Interventional, and Treatment
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.
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.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's planned enrollment of 44 is close to the median of 46 across 89 interventional studies indexed under Vulvodynia.
Browse Vulvodynia studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Patients receiving standard of care
Drug: Estradiol 0.01% Vag Cream
Patients receiving study treatment
Drug: testosterone 0.1% and estradiol 0.01% vaginal cream
0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks
Drug page: Testosterone
0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks
Typical pain with vaginal penetration within last 2 weeks
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
Time frame: at 12 weeks post-treatment
Typical pain with vaginal penetration within last 2 weeks
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
Time frame: at 6 weeks post-treatment
Sexual function
sexual function as measured by Female Sexual Function Index
Time frame: at 6 weeks and 12 weeks post-treatment
Most intense pain with vaginal penetration within last 2 weeks
Most intense pain with vaginal penetration within last 2 weeks using numeric rating scale
Time frame: at 6 weeks and 12 weeks post-treatment
Start is estimated for Dec 2025; primary completion for Jul 2026, 7 months later.
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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone