Clinical trial NCT04579991: Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female Sexual Function
Vulvovaginal Atrophy
Postmenopausal Atrophic Vaginitis
Keywords: Vulvovaginal atrophy
Genitourinary Syndrome of Menopause
Postmenopausal women
Female sexual function
Visnadin
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sexual function
timeFrame: 8-week
measure: Vulvovaginal atrophic symptoms score
timeFrame: 8-week
Secondary outcomes:
measure: Adverse event and tolerability
timeFrame: 8-week
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Sukanya Chaikittisilpa, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: