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

NCT02434887 | Completed

• 1 other identifier: KLEY HERTZ-004
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Female Dry Genital Mucosa

Outcome Measures

Primary Outcomes (1)

• Evaluation of the product's efficiency as a moisturizer through subjective evaluation

  40 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Device: KL029 Intimate Lubricant Gel

Interventions

KL029 Intimate Lubricant Gel DEVICE

Experimental group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kley Hertz S/A: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 6, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11