Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Female Dry Genital Mucosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

Group Type EXPERIMENTAL

KL029 Intimate Lubricant Gel

Intervention Type DEVICE

Interventions

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KL029 Intimate Lubricant Gel

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes