Overview

Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment

Status:
Terminated
Trial end date:
2021-02-13
Target enrollment:
Participant gender:
Summary
This study will evaluate the use of topical 5 or 10% sinecatechins, 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. Women may or may not be using estrogens. Half of the women will receive the study drug, 5 or 10% sinecatechins and half will receive placebo. In addition to the reduction or elimination of pain upon penetration, women may also experience increase in lubrication, arousal and intensity of orgasm
Phase:
Phase 2
Details
Lead Sponsor:
GTO Pharmaceutical, LLC
Treatments:
Estrogens