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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women With Vulvovaginal Atrophy, a Randomized Controlled Trial

Conditions
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Female Sexual Function, Vulvovaginal Atrophy, Postmenopausal Atrophic Vaginitis

Intervention / Treatment
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* Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
* Other: Emulgel-only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Group<br>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<br>* Topical product, apply small amount on mucosal surface of vulva included clitoris once daily<br>|
| Placebo Comparator: Placebo Group<br>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<br>* Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event and tolerability | Possible adverse event of therapeutic use | 8-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvovaginal atrophy, Genitourinary Syndrome of Menopause, Postmenopausal women, Female sexual function, Visnadin