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OpenTrials
Completed

NCT Number: NCT00779025

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

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

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Key information

Conditions

Coitus Behavior Sexual Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concentrics Center for Research

Indianapolis, Indiana, 46240, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

PD-F-5254

Device

Female Personal Lubricant (MINE)

Other names: K-Y

10855-096

Device

Male Personal Lubricant (YOURS)

Other names: K-Y

Primary outcomes

  1. Number of Participants Showing Change From Baseline in Irritation Scores

    Time frame: 1 week

    Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions

Secondary outcomes

  1. Number of Sensations Experienced by Male Subjects - Overall

    Time frame: 1 Week

    Number of sensations experienced by male subjects, based on two applications of the investigational product.

  2. Number of Sensations Experienced by Female Subjects - Overall

    Time frame: 1 Week

    Number of sensations experienced by female subjects, based on two applications of the product for each subject.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2008
Registry last updated
Oct 7, 2011

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.

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