Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Estradiol 0.01% Vag Cream, testosterone 0.1% and estradiol 0.01% vaginal cream.
- Кому может быть актуально
- Состояния в реестре: Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Estradiol 0.01% Vag Cream
0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks - Препарат 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
Первичные конечные точки
- Typical pain with vaginal penetration within last 2 weeks [Срок оценки: at 12 weeks post-treatment]
Вторичные конечные точки (3)
- Typical pain with vaginal penetration within last 2 weeks [Срок оценки: at 6 weeks post-treatment]
- Sexual function [Срок оценки: at 6 weeks and 12 weeks post-treatment]
- Most intense pain with vaginal penetration within last 2 weeks [Срок оценки: at 6 weeks and 12 weeks post-treatment]
Критерии участия
Критерии включения
- 18 years or older
- Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater
Критерии исключения
- Active vaginal infection
- Pregnancy
- Breast-feeding
- Taking anti-androgenic medication (finasteride, dutasteride)
- Using any other topical hormones to the vulva or vagina
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- Cincinnati Urogynecology Associates — Cincinnati
- TriHealth — Cincinnati
Идентификаторы
NCT: NCT07260825 · 25-108