N/A
Completed N=70
Safety Study for an All-in-One Body and Personal Lubricant
Lubricating Agents
Source: ClinicalTrials.gov NCT01189617 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Number of Subjects With Irritation Score of "0" at Baseline and One Week — 35; 35; 35; 35 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Irritation Score of "0" at Baseline and One Week |
35; 35; 35; 35 | — |
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
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. Informational only — not medical advice.