Lubricating AgentsNCT01189617
Safety Study for an All-in-One Body and Personal Lubricant
A study testing Formula PD-F-7619 in people with Lubricating Agents, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lubricating Agents
- What is being tested?
- Formula PD-F-7619
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2010
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
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.
Read the detailed description
This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.
- Conditions
- Lubricating Agents
- Being tested
- Formula PD-F-7619
- Keywords
- Personal Lubricant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula PD-F-7619Device
Also called All-In-One Caressing Crème & Personal Lubricant, K-Y Touch Massage Warming 2-in-1 Personal Lubricant
Off-White to Beige Lotion
| Study group | Role | What they receive |
|---|---|---|
| Formula PD-F-7619 | Experimental | At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed. Receives: Device: Formula PD-F-7619 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Irritation Score of "0" at Baseline and One Week
Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.
Measured: Baseline and One Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionAug 2010
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 Lubricating AgentsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherryl Frisch, Study director, Johnson & Johnson Consumer and Personal Products WorldwideMelissa Israel, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189617
- Sponsor's protocol ID
- KOYNAP0011
- Status last verified
- Jan 2017
- First submitted
- 25 Aug 2010
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
- ClinicalTrials.gov ID
- NCT01189617
- Acronym / sponsor ID
- KOYNAP0011
- Conditions
- Lubricating Agents
- Keywords
- Personal Lubricant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formula PD-F-7619 | Experimental | Device: Formula PD-F-7619At least twice per week for one week, massage about a dime-sized amount of the PD-F-7619 personal lubricant product to the application site as directed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Formula PD-F-7619Also: All-In-One Caressing Crème & Personal Lubricant, K-Y Touch Massage Warming 2-in-1 Personal LubricantOff-White to Beige Lotion | Device | Formula PD-F-7619 |
Primary outcome
Number of Subjects With Irritation Score of "0" at Baseline and One Week
Time frame: Baseline and One Week
Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- 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.
Sherryl Frisch study director
Johnson & Johnson Consumer and Personal Products Worldwide
Melissa Israel study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula PD-F-7619 in people with Lubricating Agents, run by Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. 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 5 inclusion and 3 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 27 Feb 2017. 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 10 Jan 2014). 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 Subjects With Irritation Score of "0" at Baseline and One Week (time frame: Baseline and One 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 27 Feb 2017.