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Terminated Phase 2 Interventional Accepts healthy volunteers Results available

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

NCT03682601
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
5% sinecatechins ointment, Placebo, 10% sinecatechins ointment
Drug
Lead sponsor
GTO Pharmaceutical, LLC
Other
Eligibility
20 Years to 70 Years · Female only
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2021
U.S. locations
4
States / cities
New York, New York • Nyack, New York
Conditions
Provoked Vestibulodynia, Secondary Provoked Vestibulodynia, Vulvodynia, Vulvary Pain Disorders, Neuroproliferative Vestibulodynia, Mast Cell-mediated Neuroinflammation, Instertional Dyspareunia
Interventions
Ketotifen Fumarate 0.25% Cream, Placebo (Vehicle Cream)
Drug
Lead sponsor
Center for Vulvovaginal Disorders
Other
Eligibility
18 Years and older · Female only
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
3
States / cities
Washington D.C., District of Columbia • Tampa, Florida • New York, New York