The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04579991
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579991
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Female Sexual Function Vulvovaginal Atrophy Postmenopausal Atrophic Vaginitis Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel Other: Emulgel-only Not Applicable

Detailed Description:
Topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel is a cosmetic product. Visnadin is an active ingredient which has the vasodilator effect and improve blood flow to female vulvovaginal area. This will improve lubrication from increase Bartholin's gland secretion. As the clitoral blood flow increase, the sexual response could be improved. The ethyl ximeninate, coleus barbatus and millet are plant extract which have moisturizer, anti-inflammation and antioxidant effects. Our hypothesis is a daily topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel could improved sexual function and vulvovaginal atrophic symptoms in postmenopausal women with vulvovaginal atrophy.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Pharmacist will provide the same color and texture of product and identical package for both active emulgel and emulgel only products. She is the only person who knows the code of product and prepare the product in the opaque envelop for all participants.

The statistician will generate the code of product to all participants with block-of-four randomization method.

The nurse will distribute and help the participants fill all questionnaires.
Primary Purpose: Treatment
Official Title: Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women With Vulvovaginal Atrophy, a Randomized Controlled Trial
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : November 25, 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Active Group
Apply small amount of topical visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
 Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
Placebo Comparator: Placebo Group
Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
 Other: Emulgel-only
Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sexual function [ Time Frame: 8-week ]
    Female Sexual Function Index (FSFI) The full scale (overall) score of the FSFI can be derived from the six domain scores; desire, arousal, lubrication, orgasm, satisfaction and pain. The minimum value is 2.0 and maximum value is 36.0, and the higher scores mean a better outcome.

  2. Vulvovaginal atrophic symptoms score [ Time Frame: 8-week ]
    4-likert scale; 0 = no symptom, 1= mild symptom, 2 = moderate symptom, 3 = severe symptom The minimum is 0 and maximum value is 4, and the higher scores mean a worse outcome.


Secondary Outcome Measures :
  1. Adverse event and tolerability [ Time Frame: 8-week ]
    Possible adverse event of therapeutic use


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women age 45-65 years old
  • BMI 19-29 kg/m2
  • Menopause or removal of both ovaries more than 1 year
  • Has moderate to severe vulvovaginal atrophic at least 1 symptom
  • Has sign of vulvovaginal atrophy
  • Vaginal pH ≥ 5
  • Has sexual intercourse at least 1 time/month

Exclusion Criteria:

  • Hormonal use within 3 months
  • Use vaginal estrogen/ moisturizer within 3 months
  • Use aromatase inhibitor/tamoxifen within 3 months
  • Has vaginal bleeding within 6 months
  • Acute or chronic urinary tract infection
  • History of radiation therapy at vulvovaginal and pelvic area
  • History of Diabetes mellitus or Cardiovascular disease
  • History of neurosis or psychosis
  • History of vulvovaginal cancer
  • History of smoking more than 20 cigarettes/day
  • History of alcoholic drink/ drug abuse
  • History of visnadin, ethyl ximeninate, coleus barbatus and millet allergy
  • Has disease of vulva
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579991


Contacts
Layout table for location contacts
Contact: Sukanya Chaikittisilpa, MD,MSc +66915615415 sukanya.c@chula.ac.th
Contact: Nalina Orprayoon, MD +66909908440 nalina.o@chula.ac.th

Locations
Layout table for location information
Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Pathum Wan, Bangkok, Thailand, 10330
Contact: Sukanya Chaikittisilpa    +66915615415    sukanya.c@chula.ac.th   
Contact: Nalina Orprayoon    +66909908440    nalina.o@chula.ac.th   
Principal Investigator: Sukanya Chaikittisilpa, MD,MSc         
Sub-Investigator: Nalina Orprayoon, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Layout table for investigator information
Principal Investigator: Sukanya Chaikittisilpa, MD,MSc Chulalongkorn University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT04579991    
Other Study ID Numbers: MRU20200001
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Vulvovaginal atrophy
Genitourinary Syndrome of Menopause
Postmenopausal women
Female sexual function
Visnadin
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases