Female Sexual FunctionNCT04579991
Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women
A study testing Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel and Emulgel-only in people with Female Sexual Function and Vulvovaginal Atrophy, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Female Sexual Function, Vulvovaginal Atrophy, Postmenopausal Atrophic Vaginitis
- What is being tested?
- Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel and Emulgel-only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 27 May 2021to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Chulalongkorn University
Pathum Wan, Bangkok, 10330
Sukanya Chaikittisilpa, +66915615415, sukanya.c@chula.ac.th
Nalina Orprayoon, +66909908440, nalina.o@chula.ac.th
About this study
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
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.
Read the 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.
- Being tested
- Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel, Emulgel-only
- Keywords
- Vulvovaginal atrophy, Genitourinary Syndrome of Menopause, Postmenopausal women, Female sexual function, Visnadin
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgelOther
Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
Emulgel-onlyOther
Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel |
| 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. Receives: Other: Emulgel-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8-week
Secondary outcomes (1)
Adverse event and tolerability
Possible adverse event of therapeutic use
Measured: 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start27 May 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion25 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual FunctionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sukanya Chaikittisilpa, MD,MSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579991
- Sponsor's protocol ID
- MRU20200001
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04579991
- Acronym / sponsor ID
- MRU20200001
- Keywords
- Vulvovaginal atrophy, Genitourinary Syndrome of Menopause, Postmenopausal women, Female sexual function, Visnadin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 25 Nov 2024 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgelApply 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 | Other: Emulgel-onlyApply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgelTopical product, apply small amount on mucosal surface of vulva included clitoris once daily | Other | Active Group |
| Emulgel-onlyTopical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily | Other | Placebo Group |
Primary outcome
Sexual function
Time frame: 8-week
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
Time frame: 8-week
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.
1 secondary outcome
Adverse event and tolerability
Time frame: 8-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Female Sexual Function
Recruiting
PRP for Sexual Function
Female Sexual Dysfunction, Sexual Dysfunction
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitation
THE EFFECT OF SEXUAL COUNSELING BASED ON THE EXPLISSIT MODEL ON SEXUAL FUNCTION, MARITAL ADJUSTMENT, AND QUALITY OF SEXUAL LIFE IN POSTMENOPAUSAL WOMEN
Sexual and Reproductive Health, Menopausal and Postmenopausal Women
RecruitingObservational study
Androgen Receptor, Implications for Health and Wellbeing: Natural History Study of Individuals With Androgen Insensitivity
Androgen Insensitivity Syndrome, Metabolic Parameters in AIS, CAIS, PAIS and MAIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukanya Chaikittisilpa, MD,MSc principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel and Emulgel-only in people with Female Sexual Function and Vulvovaginal Atrophy, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sukanya Chaikittisilpa, MD,MSc (+66915615415, sukanya.c@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function (time frame: 8-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.