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

Kley Hertz

Status: Completed

Conditions: Female Dry Genital Mucosa

Treatments: Device: KL029 Intimate Lubricant Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02434887

KLEY HERTZ-004

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

26 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Device: KL029 Intimate Lubricant Gel