CoitusNCT00779025
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
A study testing PD-F-5254 and 10855-096 in people with Coitus, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coitus
- What is being tested?
- PD-F-5254 and 10855-096
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy males and females >18 years of age
- In committed heterosexual relationship for >6months
- On acceptable method of birth control
Who cannot join
- Pregnant or breastfeeding
- Allergy to product ingredients
- Irritation or infection in genital area
- Unstable or uncontrolled medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Concentrics Center for Research
Indianapolis, Indiana, 46240
About this study
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
Read the detailed description
Study to evaluate the safety of Class II personal lubricant devices.
- Conditions
- Coitus
- Being tested
- PD-F-5254, 10855-096
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-F-5254Device
Also called K-Y
Female Personal Lubricant (MINE)
10855-096Device
Also called K-Y
Male Personal Lubricant (YOURS)
| Study group | Role | What they receive |
|---|---|---|
| MINE Alone | Active comparator | Female Personal Lubricant (PD-F-5254) Receives: Device: PD-F-5254 |
| YOURS and MINE | Experimental | Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254) Receives: Device: PD-F-5254; Device: 10855-096 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Showing Change From Baseline in Irritation Scores
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
Measured: 1 week
Secondary outcomes (2)
Number of Sensations Experienced by Male Subjects - Overall
Number of sensations experienced by male subjects, based on two applications of the investigational product.
Measured: 1 Week
Number of Sensations Experienced by Female Subjects - Overall
Number of sensations experienced by female subjects, based on two applications of the product for each subject.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Wanser, Study director, J&J CPPW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779025
- Sponsor's protocol ID
- CA-P-6020-1
- Status last verified
- Oct 2011
- First submitted
- 23 Oct 2008
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
- ClinicalTrials.gov ID
- NCT00779025
- Acronym / sponsor ID
- CA-P-6020-1
- Conditions
- Coitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 5 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
Detailed description
Study to evaluate the safety of Class II personal lubricant devices.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINE Alone | Active comparator | Device: PD-F-5254Female Personal Lubricant (PD-F-5254) |
| YOURS and MINE | Experimental | Device: PD-F-5254, Device: 10855-096Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal, healthy males and females >18 years of age
- In committed heterosexual relationship for >6months
- On acceptable method of birth control
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Allergy to product ingredients
- Irritation or infection in genital area
- Unstable or uncontrolled medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-F-5254Also: K-YFemale Personal Lubricant (MINE) | Device | MINE Alone, YOURS and MINE |
| 10855-096Also: K-YMale Personal Lubricant (YOURS) | Device | YOURS and MINE |
Primary outcome
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
2 secondary outcomes
Number of Sensations Experienced by Male Subjects - Overall
Time frame: 1 Week
Number of Sensations Experienced by Female Subjects - Overall
Time frame: 1 Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Wanser study director
J&J CPPW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD-F-5254 and 10855-096 in people with Coitus, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Showing Change From Baseline in Irritation Scores (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.