Evaluation of Viscosity of a Vaginal Moisturizer

Last updated: December 20, 2018
Sponsor: Farmoquimica S.A.
Overall Status: Active - Not Recruiting

Phase

4

Condition

Vaginitis

Vaginal Atrophy

Treatment

N/A

Clinical Study ID

NCT03782961
FE4 - HIDRAFEMME - PA - 010
  • Ages 45-70
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 andtimes determined for applications and / or evaluations;

  • Understanding, agreement and signing of the Informed Consent Term.

Exclusion

Exclusion Criteria:

  • Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks priorto selection;

  • Pathologies and / or active skin lesions (local and / or disseminated) in theevaluation 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 ofstudy participation.

Study Design

Total Participants: 33
Study Start date:
January 14, 2019
Estimated Completion Date:
January 25, 2019

Study 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.