Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function i… (NCT04579991) | Clinical Trial Compass
UnknownNot Applicable
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
Thailand100 participantsStarted 2021-05-27
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.