Hypogonadism Clinical Trial
Official title:
An Open-label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62%
Verified date | November 2009 |
Source | Solvay Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Site 1 | Miami Gardens | Florida |
Lead Sponsor | Collaborator |
---|---|
Solvay Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax | 4 days | No |
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