CoitusNCT00778934
In-Home Use Study to Evaluate Use of an Intimate Health Product in Females
A study testing Intimate Health Gel in people with Coitus, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coitus
- What is being tested?
- Intimate Health Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy females >18 years of age
- In committed heterosexual relationship for >6months
- Of adequate sexual functioning
- 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
2 sites in 1 country.
United States2 sites
Center for Marital and Sexual Health, Inc.
Beachwood, Ohio, 44122
Center of Marital and Sexual Health of South Florida
West Palm Beach, Florida, 33401
About this study
Official title: A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females
The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.
Read the detailed description
Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.
- Conditions
- Coitus
- Being tested
- Intimate Health Gel
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intimate Health GelOther
Also called Not marketed yet
Intimate Health Gel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intimate Health Gel Receives: Other: Intimate Health Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses
Measured: End of study (3 weeks after baseline visit)
Secondary outcomes (1)
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Measured: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
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 startDec 2007
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 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
- NCT00778934
- Sponsor's protocol ID
- CA-P-5739-1
- Status last verified
- Oct 2011
- First submitted
- 23 Oct 2008
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females
- ClinicalTrials.gov ID
- NCT00778934
- Acronym / sponsor ID
- CA-P-5739-1
- Conditions
- Coitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
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 evaluate the effects of an intimate health product on sexual experience in females.
Detailed description
Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Intimate Health GelIntimate Health Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal, healthy females >18 years of age
- In committed heterosexual relationship for >6months
- Of adequate sexual functioning
- 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 |
|---|---|---|
| Intimate Health GelAlso: Not marketed yetIntimate Health Gel | Other | 1 |
Primary outcome
To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses
Time frame: End of study (3 weeks after baseline visit)
1 secondary outcome
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intimate Health Gel in people with Coitus, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites 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 4 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 6 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses (time frame: End of study (3 weeks after baseline visit)). 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 6 Oct 2011.