A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions

Johnson & Johnson (J&J)

Status: Completed

Conditions: Coitus

Treatments: Device: 10855-096; Device: PD-F-5254

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779025

CA-P-6020-1

Details and patient eligibility

About

The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.

Full description

Study to evaluate the safety of Class II personal lubricant devices.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal, healthy males and females >18 years of age
• In committed heterosexual relationship for >6months
• On acceptable method of birth control

Exclusion criteria

• Pregnant or breastfeeding
• Allergy to product ingredients
• Irritation or infection in genital area
• Unstable or uncontrolled medical condition

Trial design

82 participants in 2 patient groups

MINE Alone

Active Comparator group

Description:

Female Personal Lubricant (PD-F-5254)

Treatment:

Device: PD-F-5254

YOURS and MINE

Experimental group

Description:

Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)

Treatment:

Device: PD-F-5254

Device: 10855-096