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Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00998933
First received: October 20, 2009
Last updated: November 24, 2009
Last verified: November 2009

October 20, 2009
November 24, 2009
October 2009
October 2009   (final data collection date for primary outcome measure)
Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998933 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadism
Drug: Testosterone gel 1.62%
5 grams applied topically to upper arms/shoulder and abdomen on Day 1
Experimental: 1
Intervention: Drug: Testosterone gel 1.62%
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. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

Exclusion Criteria:

  • Males: history, current or suspected prostate or breast cancer.
  • Female: pregnant or lactating.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00998933
S176.1.009
No
Barbara Parker, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP