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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2024-11-25

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.

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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.

Conditions

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Female Sexual Function Vulvovaginal Atrophy Postmenopausal Atrophic Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel

Intervention Type OTHER

Topical product, apply small amount on mucosal surface of vulva included clitoris once daily

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Emulgel-only

Intervention Type OTHER

Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Interventions

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Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel

Topical product, apply small amount on mucosal surface of vulva included clitoris once daily

Intervention Type OTHER

Emulgel-only

Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Intervention Type OTHER

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No