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N/A N=70

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

Lubricating Agents

Bottom Line

View on ClinicalTrials.gov: NCT01189617 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Number of Subjects With Irritation Score of "0" at Baseline and One Week — 35; 35; 35; 35 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Formula PD-F-7619 (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Primary completion
Jun 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Irritation Score of "0" at Baseline and One Week		 35; 35; 35; 35 —

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01189617). 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.

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