Clinical Trial

Pain in Postmenopausal Women

Study Description

Topical Treatment for Sexual Pain, Vulvar Pain, in Postmenopausal Women Not Taking Estrogens or Similar Hormones. Women on Aromatase Inhibitors or Tamoxifen CAN Enter the Clinical Trial

This study will evaluate the use of topical 10% sinecatechins,(diluted Veregen) a botanical drug derived from green tea for the alleviation of sexual pain in the area around the vaginal opening (the vulvar vestibule), that is a main source of pain during sexual contact or dyspareunia, in postmenopausal women, with vulvovaginal atrophy, not willing or able to use estrogens. Half of the women will receive the study drug, 10% sinecatechins (diluted Veregen) and half will receive placebo. Women may also experience increase in lubrication, arousal and intensity of orgasm

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Sinecatechins Topical

Topical sinecatechins ointment will be applied daily.

Placebo

Aquaphor/vehicle

Additional Information

Official Study Title

10% Sinecatechins Ointment, a Botanical Drug Derived From Green Tea, for the Treatment of Significant to Severe Secondary Provoked Vestibulodynia in Sexually Active, Post-Menopausal Women With Vulvovaginal Atrophy

Clinical Trial ID

NCT03682601

ParticipAid ID

elY25a