In-Home Use Study to Evaluate Use of an Intimate Health Product in Females
This study has been completed.
Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT00778934
First received: October 23, 2008
Last updated: October 4, 2011
Last verified: October 2011
| Tracking Information | |||||
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| First Received Date ICMJE | October 23, 2008 | ||||
| Last Updated Date | October 4, 2011 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00778934 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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) ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | In-Home Use Study to Evaluate Use of an Intimate Health Product in Females | ||||
| Official Title ICMJE | A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females. |
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| Detailed Description | Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Coitus | ||||
| Intervention ICMJE | Other: Intimate Health Gel
Intimate Health Gel
Other Name: Not marketed yet |
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| Study Arm (s) | Experimental: 1
Intimate Health Gel
Intervention: Other: Intimate Health Gel |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 79 | ||||
| Completion Date | April 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00778934 | ||||
| Other Study ID Numbers ICMJE | CA-P-5739-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Johnson & Johnson Consumer and Personal Products Worldwide | ||||
| Study Sponsor ICMJE | Johnson & Johnson Consumer and Personal Products Worldwide | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johnson & Johnson Consumer and Personal Products Worldwide | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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