Evaluation of Viscosity of a Vaginal Moisturizer

Study Overview
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Brief Summary
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To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women

Detailed Description
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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.

Official Title
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Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women

Conditions
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Vaginal Dryness, Menopausal Women

Intervention / Treatment
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* Device: sodium lactate and combination of polymers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stand up<br>After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes | Device: sodium lactate and combination of polymers<br>* sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)<br>|
| Experimental: Lying down<br>After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes; | Device: sodium lactate and combination of polymers<br>* sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)<br>|

What is the study measuring?
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Primary Outcome Measures

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