Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
Primary Purpose
Female Sexual Function, Vulvovaginal Atrophy, Postmenopausal Atrophic Vaginitis
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
Emulgel-only
Sponsored by
About this trial
This is an interventional treatment trial for Female Sexual Function focused on measuring Vulvovaginal atrophy, Genitourinary Syndrome of Menopause, Postmenopausal women, Female sexual function, Visnadin
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
Sites / Locations
- Faculty of Medicine, Chulalongkorn UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Group
Placebo Group
Arm Description
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.
Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Adverse event and tolerability
Possible adverse event of therapeutic use
Full Information
NCT ID
NCT04579991
First Posted
October 6, 2020
Last Updated
February 8, 2023
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT04579991
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Function, Vulvovaginal Atrophy, Postmenopausal Atrophic Vaginitis
Keywords
Vulvovaginal atrophy, Genitourinary Syndrome of Menopause, Postmenopausal women, Female sexual function, Visnadin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
Intervention Type
Other
Intervention Name(s)
Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
Intervention Description
Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
Intervention Type
Other
Intervention Name(s)
Emulgel-only
Intervention Description
Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily
Primary Outcome Measure Information:
Title
Sexual function
Description
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
Title
Vulvovaginal atrophic symptoms score
Description
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
Secondary Outcome Measure Information:
Title
Adverse event and tolerability
Description
Possible adverse event of therapeutic use
Time Frame
8-week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sukanya Chaikittisilpa, MD,MSc
Phone
+66915615415
Email
sukanya.c@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Nalina Orprayoon, MD
Phone
+66909908440
Email
nalina.o@chula.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sukanya Chaikittisilpa, MD,MSc
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sukanya Chaikittisilpa
Phone
+66915615415
Email
sukanya.c@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Nalina Orprayoon
Phone
+66909908440
Email
nalina.o@chula.ac.th
First Name & Middle Initial & Last Name & Degree
Sukanya Chaikittisilpa, MD,MSc
First Name & Middle Initial & Last Name & Degree
Nalina Orprayoon, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
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