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Clinical Trials/NCT02434887
NCT02434887
Completed
Not Applicable

Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women

Kley Hertz S/A0 sites26 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Female Dry Genital Mucosa
Sponsor
Kley Hertz S/A
Enrollment
26
Primary Endpoint
Evaluation of the product's efficiency as a moisturizer through subjective evaluation
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Kley Hertz S/A
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female aged between 45 to 65 years old
  • Sexually active volunteers, with a minimum of 1 intercourse per week
  • In menopause for at least 6 months;
  • Intact skin in the product analysis region;
  • No prior reactions to topical products
  • Reading, understanding, agreement and signature of the informed consent form

Exclusion Criteria

  • Use of anti-inflammatory and immunosuppressive ( in the last 30 days and during the study)
  • Active skin diseases (local or disseminated) in the evaluation área;
  • Diseases that cause imune suppression;
  • Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
  • Any infection in the region where the product will be analyzed diagnosed at enrollment;
  • Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Outcomes

Primary Outcomes

Evaluation of the product's efficiency as a moisturizer through subjective evaluation

Time Frame: 40 days

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