N/A N=82 Randomized

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

Coitus

Bottom Line

View on ClinicalTrials.gov: NCT00779025 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2011

Primary outcome: Primary: Number of Participants Showing Change From Baseline in Irritation Scores — 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PD-F-5254 (Device); 10855-096 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Showing Change From Baseline in Irritation Scores	0; 0	—
SECONDARY Number of Sensations Experienced by Male Subjects - Overall	0; 0; 2; 0; 2; 3	—
SECONDARY Number of Sensations Experienced by Female Subjects - Overall	1; 0; 4; 6; 4; 0	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00779025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.