Topical treatment for improving sexual function in postmenopausal women
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women With Vulvovaginal Atrophy, a Randomized Controlled Trial
This study is testing a new topical gel to see if it can help improve sexual function in postmenopausal women dealing with vaginal dryness and discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Chulalongkorn University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Pathum Wan, Bangkok) |
| Trial ID | NCT04579991 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind randomized controlled trial aimed at evaluating the effects of a topical emulgel containing visnadin, ethyl ximeninate, coleus barbatus, and millet on sexual function in postmenopausal women suffering from vulvovaginal atrophy. Participants will apply the emulgel daily for eight weeks, and the study will compare the active treatment to an emulgel-only control. The trial will assess improvements in sexual function, symptoms of vulvovaginal atrophy, as well as the safety and tolerability of the treatment. Conducted at the Menopause Clinic and Gynecology Clinic of King Chulalongkorn Memorial Hospital in Bangkok, Thailand, the study aims to provide insights into non-hormonal treatment options for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 45-65 with moderate to severe vulvovaginal atrophy symptoms.
Not a fit: Patients currently using hormonal treatments or with a history of certain medical conditions, such as diabetes or vulvovaginal cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance sexual function and quality of life for postmenopausal women experiencing vulvovaginal atrophy.
How similar studies have performed: While there have been studies on topical treatments for vulvovaginal atrophy, the specific combination of ingredients in this trial is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pathum Wan, Bangkok
- Faculty of Medicine, Chulalongkorn University — Pathum Wan, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Sukanya Chaikittisilpa, MD,MSc — Chulalongkorn University
- Study coordinator: Sukanya Chaikittisilpa, MD,MSc
- Email: sukanya.c@chula.ac.th
- Phone: +66915615415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.