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Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women

NCT04579991 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-22

No results posted yet for this study

Summary

This clinical trial, a double blind randomized controlled trial, is conducted to determine the effects of daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on sexual function in postmenopausal women with vulvovaginal atrophy within 8-week of treatment. We compare the active ingredient in emulgel to the emulgel only. We also evaluate the improvement of the vulvovaginal atrophy symptoms in postmenopausal women, the safety and the tolerability of visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel. This study is conducted in the Menopause Clinic and the Gynecology Clinic, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Conditions

  • Female Sexual Function
  • Vulvovaginal Atrophy
  • Postmenopausal Atrophic Vaginitis

Interventions

OTHER

Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel

Topical product, apply small amount on mucosal surface of vulva included clitoris once daily

OTHER

Emulgel-only

Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Sukanya Chaikittisilpa, MD,MSc · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-04-30
Completion
2024-11-25

Countries

  • Thailand

Study Locations

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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 NCT04579991 on ClinicalTrials.gov