Safety Study for an All-in-One Body and Personal Lubricant

McNeil-PPC

Status: Completed

Conditions: Lubricating Agents

Treatments: Device: Formula PD-F-7619

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189617

KOYNAP0011

Details and patient eligibility

About

This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.

Full description

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
• Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
• Able to read and understand English
• Voluntarily signs an Informed Consent document after the trial has been explained
• Willing to follow all study procedures, including birth control requirements

Exclusion criteria

• Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
• Participation as a research subject in a different trial within timelines dictated by protocol
• Participants with relationships or employment outside protocol-defined parameters

Trial design

70 participants in 1 patient group

Formula PD-F-7619

Experimental group

Description:

At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed.

Treatment:

Device: Formula PD-F-7619