Oral Testosterone for the Treatment of Hypogonadism
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | December 2014 |
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.
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.
Inclusion Criteria:
- Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum
testosterone < 300 ng/dL (based on the average of 2 morning samples taken at least 1
week apart)
- Men over the age of 18 years with a body mass index (BMI) < 39.0 kg/m2 and weighing ≥
55 kg
- Hemoglobin levels at screening and baseline > 12.5 g/dL
- Testosterone treatment not contraindicated
- No evidence of suspected reversible hypogonadism
- Willing to abstain from current treatment for hypogonadism in accordance with
approved labeling to facilitate an appropriate washout period before study
participation (for nondepot formulations of testosterone only)
- Understands the requirements of the study and voluntarily consents to participate in
the study
Exclusion Criteria:
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