Oral Testosterone for the Treatment of Hypogonadism

Condition(s) targeted: Hypogonadism

Intervention: TSX-002 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TesoRx Pharma, LLC

Official(s) and/or principal investigator(s):
John Kowalczyk, DO, FACOS, Principal Investigator, Affiliation: Urology Group of Southern California

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.

Official title: A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total serum testosterone

Secondary outcome:

Proportion of subjects with total serum testosterone levels above normal range

Safety of TSX-002

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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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Urology Group of Southern California, Los Angeles, California 90048, United States

Starting date: October 2012
Last updated: June 27, 2014