Completed

NCT Number: NCT01189617

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lubricating Agents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concentrics Research

Indianapolis, Indiana, 46240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula PD-F-7619

Device

Off-White to Beige Lotion

Other names: All-In-One Caressing Crème & Personal Lubricant, K-Y Touch Massage Warming 2-in-1 Personal Lubricant

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Aug 26, 2010
Registry last updated: Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.