Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Typical pain with vaginal penetration within last 2 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater
排除标准
- •Active vaginal infection
- •Pregnancy
- •Breast-feeding
- •Taking anti-androgenic medication (finasteride, dutasteride)
- •Using any other topical hormones to the vulva or vagina
研究组 & 干预措施
Standard of care
Patients receiving standard of care
干预措施: Estradiol 0.01% Vag Cream (Drug)
Treatment
Patients receiving study treatment
干预措施: testosterone 0.1% and estradiol 0.01% vaginal cream (Drug)
结局指标
主要结局
Typical pain with vaginal penetration within last 2 weeks
时间窗: at 12 weeks post-treatment
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
次要结局
- Typical pain with vaginal penetration within last 2 weeks(at 6 weeks post-treatment)
- Sexual function(at 6 weeks and 12 weeks post-treatment)
- Most intense pain with vaginal penetration within last 2 weeks(at 6 weeks and 12 weeks post-treatment)