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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Group | Active Comparator | 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. |
|
| Placebo Group | Placebo Comparator | Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel | Other | Topical product, apply small amount on mucosal surface of vulva included clitoris once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event and tolerability | Possible adverse event of therapeutic use | 8-week |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukanya Chaikittisilpa, MD,MSc | Contact | +66915615415 | sukanya.c@chula.ac.th | |
| Nalina Orprayoon, MD | Contact | +66909908440 | nalina.o@chula.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Sukanya Chaikittisilpa, MD,MSc | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Recruiting | Pathum Wan | Bangkok | 10330 | Thailand |
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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.
| Emulgel-only | Other | Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily |
|
| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C067604 | visnadin |
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