Hypogonadism Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism
Low testosterone is a condition that occurs when the body is unable to produce sufficient
quantities of testosterone. The medical name for low testosterone is hypogonadism.
Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
energy and mood swings. The goal of testosterone replacement therapy is to return
testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of TSX-002, which is testosterone
provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within
the normal range in hypogonadal men. This will be determined by blood sampling at specified
times during the study. The study is also intended to evaluate the tolerability of TSX-002,
which will be taken orally twice per day for 15 days. In addition, the study is intended to
determine a dosing regimen(s) that achieves testosterone levels within the normal range.
Related Outcome Measures will be reported for Parts 1, 2, and 4.
A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal
on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be
reported for Part 3.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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