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Clinical trialNCT03682601TerminatedPhase 2Interventional

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

SponsorGTO Pharmaceutical, LLCEnrollment32Arousal Disorders, SexualDyspareuniaFemale Sexual Arousal DisorderFemale Sexual DysfunctionGenito-Pelvic Pain/Penetration DisorderPostmenopausal Symptoms+4 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Cynthia Krause, M.D.

    New York, New York, United States

  • Lila Nachtigall, M.D.

    New York, New York, United States

  • Miriam Greene, M.D.

    New York, New York, United States

  • Janis Enzenbacher, M.D.

    Nyack, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

10% sinecatechins ointment5% sinecatechins ointmentPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Aug 2018
Primary completion
12 Feb 2021
Completion
13 Feb 2021
Last update posted
27 Jul 2022
Registered enrollment
32
Registry id
NCT03682601
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.