Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women With Vulvovaginal Atrophy, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Vulvovaginal atrophic symptoms score
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel (Other)
Placebo Group
Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
Intervention: Emulgel-only (Other)
Outcomes
Primary Outcomes
Vulvovaginal atrophic symptoms score
Time Frame: 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.
Sexual function
Time Frame: 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.
Secondary Outcomes
- Adverse event and tolerability(8-week)