Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00998933
First received: October 20, 2009
Last updated: November 24, 2009
Last verified: November 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 20, 2009 | ||||
| Last Updated Date | November 24, 2009 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 4 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00998933 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure | ||||
| Official Title ICMJE | An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% | ||||
| Brief Summary | To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hypogonadism | ||||
| Intervention ICMJE | Drug: Testosterone gel 1.62%
5 grams applied topically to upper arms/shoulder and abdomen on Day 1 |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: Testosterone gel 1.62% |
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| Publications * | Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. Epub 2012 Jan 24. | ||||
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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 | 24 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| 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 | NCT00998933 | ||||
| Other Study ID Numbers ICMJE | S176.1.009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Barbara Parker, Solvay Pharmaceuticals | ||||
| Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | November 2009 | ||||
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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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