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

Sponsor

Chulalongkorn University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04579991

Collaborator

(none)

100

Enrollment

Location

Arms

10.1

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Sexual function [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.
Vulvovaginal atrophic symptoms score [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

Adverse event and tolerability [8-week]
Possible adverse event of therapeutic use

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Pathum Wan	Bangkok	Thailand	10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

Principal Investigator: Sukanya Chaikittisilpa, MD,MSc, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT04579991

Other Study ID Numbers:

MRU20200001

First Posted:

Oct 8, 2020

Last Update Posted:

Aug 11, 2021

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chulalongkorn University

Vulvovaginal atrophy

Genitourinary Syndrome of Menopause

Postmenopausal women

Female sexual function

Visnadin

Additional relevant MeSH terms:

Vaginitis

Atrophic Vaginitis

Atrophy

Study Results

No Results Posted as of Aug 11, 2021