NCT03682601

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: GTO Pharmaceutical, LLC · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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

Detailed description

Topical Veregen (15% sinecatechins) is an FDA approved botanical drug derived from green tea and is approved to be used as multiple doses, three times a day to treat all visible external genital warts. Topical green tea ointment has been shown to alleviate pain and improve wound healing in the vulvar vestibule for women who have had a recent episiotomy in the medical literature. In private clinical practice, dilute Veregen, sinecatechins ointment, has been effective in alleviating , sexual pain, vulvar vestibular pain, dyspareunia, in postmenopausal women as well as improving overall sexual satisfaction,( increasing lubrication, arousal and quality of orgasm). In this study, dilute Veregen, (5 or 10% sinecatechins) or placebo is being applied, as a single dose, topically, three times/week up to once a day, to alleviate pain in the vulvar vestibule, penetration pain, upon sexual contact or other manipulation of this area in postmenopausal women. Women are eligible whether or not they are currently using any form of estrogen or other hormonal treatments (eg. DHEA). Please note that women not using estrogen or who maybe taking aromatase inhibitors, tamoxifen, SERMS, are also eligible to be included.

Conditions

• Sexual Pain Disorders
• Postmenopausal Symptoms
• Vulvovaginal Atrophy
• Female Sexual Dysfunction
• Dyspareunia
• Vulvodynia
• Vestibulodynia
• Arousal Disorders, Sexual
• Genito-Pelvic Pain/Penetration Disorder
• Female Sexual Arousal Disorder

Interventions

Type	Name	Description
DRUG	5% sinecatechins ointment	Topical 5% sinecatechins ointment will be applied once daily.
DRUG	Placebo	Aquaphor/vehicle
DRUG	10% sinecatechins ointment	Topical 10% sinecatechins ointment will be applied three times per week up to once daily.

Timeline

• Start date: 2018-08-30
• Primary completion: 2021-02-12
• Completion: 2021-02-13
• First posted: 2018-09-24
• Last updated: 2022-07-27
• Results posted: 2022-06-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study