Effects of Visnadin, Ethyl Ximeninate, Coleus Barbatus and Millet in Emulgel on Sexual Function in Postmenopausal Women

• ClinicalTrials.gov Identifier: NCT04579991
• Recruitment Status: Recruiting
• First Posted: October 8, 2020
• Last Update Posted: March 22, 2024
• Sponsor: Chulalongkorn University
• Information provided by (Responsible Party): Chulalongkorn University

Tracking Information

• First Submitted Date: October 6, 2020
• First Posted Date: October 8, 2020
• Last Update Posted Date: March 22, 2024
• Actual Study Start Date: May 27, 2021
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2020)

• 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.

Original Primary Outcome Measures (submitted: October 6, 2020)

• Sexual function [ Time Frame: 8-week ]
  Female sexual function index score
• Vulvovaginal atrophic symptoms score [ Time Frame: 8-week ]
  4-likert scale

Current Secondary Outcome Measures (submitted: October 6, 2020)

Adverse event and tolerability [ Time Frame: 8-week ]

Possible adverse event of therapeutic use

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment

Condition

• Female Sexual Function
• Vulvovaginal Atrophy
• Postmenopausal Atrophic Vaginitis

Intervention

• Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
  Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
• Other: Emulgel-only
  Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Study Arms

• Active Comparator: Active Group
  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.
  Intervention: Other: Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel
• Placebo Comparator: Placebo Group
  Apply small amount of topical emulgel-only on mucosal surface of vulva included clitoris every day before bedtime for 8-week period.
  Intervention: Other: Emulgel-only

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 6, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 25, 2024
• Estimated Primary Completion Date: April 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Postmenopausal women

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sukanya Chaikittisilpa, MD,MSc; +66915615415; sukanya.c@chula.ac.th

Contact: Nalina Orprayoon, MD; +66909908440; nalina.o@chula.ac.th

• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT04579991
• Other Study ID Numbers: MRU20200001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Chulalongkorn University
• Original Responsible Party: Same as current
• Current Study Sponsor: Chulalongkorn University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sukanya Chaikittisilpa, MD,MSc; Chulalongkorn University

• PRS Account: Chulalongkorn University
• Verification Date: March 2024