The Effect of Non-hormonal Gel Application in Women in the Menacme With Sexual Dysfunction

NCT04015037 | Completed

• 1 other identifier: 933.092
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present randomized, double-blind study is to evaluate the effects of a vulvar, moisturizing, non-hormonal gel containing visnadine, ethil ximeninate, Coleus barbatus and Panicum miliaceum (TROFIS (R)), in women in the menacme, regarding the sexual response measured by the Female Sexual Function Index (FSFI) when compared to placebo.

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• improvement of sexual desire

  The aim of the present randomized, double-blind study is to evaluate the effects of a vulvar, moisturizing, non-hormonal gel containing visnadine, ethil ximeninate, Coleus barbatus and Panicum miliaceum (TROFIS (R)), in women in the menacme, regarding the sexual response measured by the Female Sexual Function Index (FSFI) when compared to placebo.

  30 days

Study Arms (2)

Group A

EXPERIMENTAL

The participants will be with age greater than 20 old, be in either the menacme (not pregnant). They will have complaints about sexual activity, an active sex life, and body mass index (BMI) equal to or less than 30. Through these criteria of inclusion and exclusion

Combination Product: placebo or drug

Group B

EXPERIMENTAL

The participants will be with age greater than 20 old, be in either the menacme (not pregnant). They will have complaints about sexual activity, an active sex life, and body mass index (BMI) equal to or less than 30. Through these criteria of inclusion and exclusion

Combination Product: placebo or drug

Interventions

placebo or drug COMBINATION_PRODUCT

Group A and B (medicated or placebo)

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- women with age greater than 20, in the menacme, with complaints about sexual activity.

You may not qualify if:

• body mass index (BMI) greater than 30

Sponsors & Collaborators

• JULIANA AQUINO DE MOURA: lead

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants. Select all that apply.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized double-blind placebo-controlled study with women with age greater than 20, in the menacme, with complaints about sexual activity.

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: July 10, 2019
• Study Start: October 20, 2015
• Primary Completion: December 10, 2016
• Study Completion: December 10, 2016
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share