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

Vulvovaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579991
• Other study ID #: MRU20200001
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: November 25, 2024

Study information

• Verified date: March 2024
• Source: Chulalongkorn University
• Contact: Sukanya Chaikittisilpa, MD,MSc
• Phone: +66915615415
• Email: sukanya.c[@]chula.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 25, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Female Sexual Function
• Postmenopausal Atrophic Vaginitis
• Vaginitis
• Vulvovaginal Atrophy

Intervention

Other:
• Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
• Emulgel-only
Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual function	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.	8-week
Primary	Vulvovaginal atrophic symptoms score	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.	8-week
Secondary	Adverse event and tolerability	Possible adverse event of therapeutic use	8-week