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

Chulalongkorn University

Status: Enrolling

Conditions: Postmenopausal Atrophic Vaginitis; Female Sexual Function; Vulvovaginal Atrophy

Treatments: Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel; Other: Emulgel-only

Study type: Interventional

Funder types: Other

Identifiers

NCT04579991

MRU20200001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Active Group

Active Comparator group

Description:

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.

Treatment:

Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel

Placebo Group

Placebo Comparator group

Description:

Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.

Treatment:

Other: Emulgel-only