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

NCT04579991 | Recruiting

• 1 other identifier: MRU20200001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Sexual Function; Vulvovaginal Atrophy; Postmenopausal Atrophic Vaginitis

Keywords

Vulvovaginal atrophy; Genitourinary Syndrome of Menopause; Postmenopausal women; Female sexual function; Visnadin

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Adverse event and tolerability

  8-week

Study Arms (2)

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.

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.

Other: Emulgel-only

Interventions

Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel OTHER

Topical product, apply small amount on mucosal surface of vulva included clitoris once daily

Active Group

Emulgel-only OTHER

Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily

Placebo Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

visnadin

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sukanya Chaikittisilpa, MD,MSc

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sukanya Chaikittisilpa, MD,MSc

CONTACT

+66915615415; sukanya.c@chula.ac.th

Nalina Orprayoon, MD

CONTACT

+66909908440; nalina.o@chula.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 8, 2020
• Study Start: May 27, 2021
• Primary Completion: April 30, 2024
• Study Completion: November 25, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)