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

NCT03682601 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-07-27

Study results available
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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

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

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.

Sponsors & Collaborators

  • GTO Pharmaceutical, LLC

    lead OTHER

Principal Investigators

  • Lila Nachtigall, M.D. · Rapid Medical Research, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2021-02-12
Completion
2021-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682601 on ClinicalTrials.gov