NCT Number: NCT02434887
Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.
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Conditions
Age range
45 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Evaluation of the product's efficiency as a moisturizer through subjective evaluation
Time frame: 40 days
Sponsors and collaborators
Lead sponsor
Kley Hertz S/A
Industry
Registry information
Acronym: CLIN ST EF EV
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 6, 2015
- Registry last updated
- Nov 10, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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