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

Female Dry Genital Mucosa Clinical Trial

— CLIN ST EF EV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434887
• Other study ID #: KLEY HERTZ-004
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: November 9, 2015
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Kley Hertz S/A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Dry Genital Mucosa

Intervention

Device:
• KL029 Intimate Lubricant Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kley Hertz S/A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the product's efficiency as a moisturizer through subjective evaluation		40 days