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

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

Study Overview

• Status: Completed
• Conditions: Female Dry Genital Mucosa
• Intervention / Treatment: Device: KL029 Intimate Lubricant Gel

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Device: KL029 Intimate Lubricant Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the product's efficiency as a moisturizer through subjective evaluation	40 days

Collaborators and Investigators

• Sponsor: Kley Hertz S/A

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: KLEY HERTZ-004