Evaluation of Viscosity of a Vaginal Moisturizer

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

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

Study Overview

• Status: Unknown
• Conditions: Vaginal Dryness; Menopausal Women
• Intervention / Treatment: Device: sodium lactate and combination of polymers

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 Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stand up; After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes	Device: sodium lactate and combination of polymers; sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)
Experimental: Lying down; 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; sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Farmoquimica S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 14, 2019
• Primary Completion (Anticipated): January 25, 2019
• Study Completion (Anticipated): January 25, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FE4 - HIDRAFEMME - PA - 010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No