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Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women (CLIN ST EF EV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02434887
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : November 10, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Female Dry Genital Mucosa Device: KL029 Intimate Lubricant Gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
Study Start Date : June 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Experimental group Device: KL029 Intimate Lubricant Gel

Primary Outcome Measures :
  1. Evaluation of the product's efficiency as a moisturizer through subjective evaluation [ Time Frame: 40 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Kley Hertz S/A Identifier: NCT02434887    
Other Study ID Numbers: KLEY HERTZ-004
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015