An interventional study of Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel and Emulgel-only in Female Sexual Function, Vulvovaginal Atrophy and Postmenopausal Atrophic Vaginitis, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment
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.
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
Other: Emulgel-only
Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily
Sexual function
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.
Time frame: 8-week
Vulvovaginal atrophic symptoms score
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.
Time frame: 8-week
Adverse event and tolerability
Possible adverse event of therapeutic use
Time frame: 8-week
Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Apr 2024, 35 months after the start.
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