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
ConditionsFemale Dry Genital Mucosa
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.
Investigators
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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