N/A
Completed N=82
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
Coitus
Source: ClinicalTrials.gov NCT00779025 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Number of Participants Showing Change From Baseline in Irritation Scores — 0; 0 Participants
Summary
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
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 | — |
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
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. Informational only — not medical advice.