Oral Testosterone for the Treatment of Hypogonadism in Males

Therapuetic Areas:Endocrinology
Age Range:18 - 70
Start Date:September 2014
Contact:Michael G Oefelein, MD. FACS

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A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males

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 pharmacokinetic (PK) parameters of testosterone
after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men.
This will be determined by blood sampling at specified times during the study. The study is
also intended to evaluate the PK parameters of the testosterone metabolite,
dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study
consists of three (3) periods, for which TSX-002 will be taken orally at various doses.
Study duration is approximately 9 weeks.

Inclusion Criteria:

- Symptomatic hypogonadal male subjects (Testosterone > 100 and <300 ng/dL, two
separate 10 am samples one week apart),

- 18-70 years old,

- Willing and able to provide informed consent and to participate in all 3 periods of
the study.

- BMI < 35 kg/m2.

Exclusion Criteria:

- Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel
Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery;
Short bowel syndrome, Lactose intolerance);

- Alcoholics or substance abuse;

- Gastroparesis; IPSS (International Prostate Symptom score) > 19; PSA
(prostate-specific antigen)> 4 ng/ml;

- Congestive Heart Failure, uncontrolled (NYHC >1);

- Uncontrolled sleep apnea;

- Topical or injectable testosterone replacement therapy (any kind including
dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;

- Testopel excluded if within 2 years;

- Aveed excluded if within past 6 months;

- Hematocrit > 50.
We found this trial at
San Diego, California 92120
San Diego, CA
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