Evaluation of Viscosity of a Vaginal Moisturizer

NCT ID: NCT03782961

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2019-01-25

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.

Conditions

Vaginal Dryness; Menopausal Women

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stand up

After application of the product (sodium lactate and combination of polymers) will remain standing for 30 minutes

Group Type: EXPERIMENTAL

sodium lactate and combination of polymers

Intervention Type: DEVICE

sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)

Lying down

After application of the product (sodium lactate and combination of polymers) remained lying down with the legs stretched for 30 minutes;

Group Type: EXPERIMENTAL

sodium lactate and combination of polymers

Intervention Type: DEVICE

sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)

Interventions

sodium lactate and combination of polymers

sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Farmoquimica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FE4 - HIDRAFEMME - PA - 010

Identifier Type: -

Identifier Source: org_study_id