Status:
COMPLETED
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Hypogonadism
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.
Eligibility Criteria
Inclusion
- Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).
Exclusion
- Males: history, current or suspected prostate or breast cancer.
- Female: pregnant or lactating.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00998933
Start Date
October 1 2009
End Date
October 1 2009
Last Update
November 25 2009
Active Locations (1)
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1
Site 1
Miami Gardens, Florida, United States