Evaluation of Viscosity of a Vaginal Moisturizer

Phase 4

• Conditions: Vaginal Dryness; Menopausal Women
• Interventions: Device: sodium lactate and combination of polymers

• Registration Number: NCT03782961
• Lead Sponsor: Farmoquimica S.A.

Brief Summary

To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women

Detailed Description

A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.

It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.

The participant will remain in the study for one day, making use of the research product in the Research Center.

Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.

Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.

A gynecologist will be available to monitor the participants throughout the study.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21
• Study Start: 2019-01-14
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Menopausal participants for at least 6 months;
• Participants with complaints of vaginal dryness;
• Skin integrity in the region of product analysis;
• Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
• Understanding, agreement and signing of the Informed Consent Term.

Exclusion Criteria

• Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
• Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
• Immunosuppression by drugs or active diseases;
• Decompensated endocrinopathies;
• Relevant clinical history or current evidence of alcohol or other drug abuse;
• known history or suspected intolerance to products of the same category;
• Intense sun exposure up to 15 days before evaluation;
• Gynecological treatment up to 4 weeks before evaluation;
• Other conditions considered by the researcher to be reasonable for disqualification of study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stand up	sodium lactate and combination of polymers	After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes
Lying down	sodium lactate and combination of polymers	After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;

Primary Outcome Measures

Name	Time	Method
To evaluate subjectively the perceived viscosity change	Immediately after application, 15 and 30 minutes after application	Perceived viscosity change of the research product from the point of view of the target public under normal conditions of use through a questionnaire