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

NCT01189617 | Completed Results

• 1 other identifier: KOYNAP0011
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lubricating Agents

Keywords

Personal Lubricant

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Irritation Score of "0" at Baseline and One Week

  Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.

  Baseline and One Week

Study Arms (1)

Formula PD-F-7619

EXPERIMENTAL

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.

Device: Formula PD-F-7619

Interventions

Formula PD-F-7619 DEVICE

Off-White to Beige Lotion

Also known as: All-In-One Caressing Crème & Personal Lubricant, K-Y Touch Massage Warming 2-in-1 Personal Lubricant

Formula PD-F-7619

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.: lead

Study Sites (1)

Concentrics Research

Indianapolis, Indiana, 46240, United States

Location

Results Point of Contact

• Title: Joyce Hauze, Sr. Specialist
• Organization: Johnson & Johsnon Consumer and Personal Products Worldwide

jhauze@its.jnj.com

9285-277-0715

Study Officials

• Sherryl Frisch

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

• Melissa Israel

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 27, 2017
• Results First Posted: January 10, 2014

Record last verified: 2017-01

Locations

US (1)