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Blood Collection Methodology for Oral Testosterone Undecanoate
NCT02670343Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- Clarus Therapeutics
- Modality
- Hormone, Biologic
- Conditions
- Hypogonadism
01
Overview
Phase 2, open-label, single-arm trial of testosterone undecanoate in Hypogonadism, sponsored by Clarus Therapeutics. Primary endpoint: % of Mean Difference in T Concentration Compared to Plain Collection Tube at 12 hours. Started Jan 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Oral Testosterone Undecanoate
Single oral dose of testosterone undecanoate (158 mg)
03
Who it enrols
Adult males with hypogonadism (T < 300 ng/dL), BMI 18-37, no significant liver/kidney/heart disease, no prostate issues, and willing to washout prior T therapy.
04
Endpoints
Primary
% of Mean Difference in T Concentration Compared to Plain Collection Tube
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