Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
Not Applicable
Completed
- Conditions
- Female Dry Genital Mucosa
- Registration Number
- NCT02434887
- Lead Sponsor
- Kley Hertz S/A
- Brief Summary
The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluation of the product's efficiency as a moisturizer through subjective evaluation 40 days
- Secondary Outcome Measures
Name Time Method