Clinical trial NCT01717768: Oral Testosterone for the Treatment of Hypogonadism
Official title: A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Keywords: hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anabolic Agents
Lead sponsor: TesoRx Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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:

-

Primary outcomes:
measure: Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002
timeFrame: 15 days
Secondary outcomes:
measure: Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
timeFrame: 15 days
Other outcomes:
measure: Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
timeFrame: 24 hrs
measure: AUC 0-24 Hrs After 120 mg Dose of TSX-002
timeFrame: 24 hrs
Locations:
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
Study officials:
affiliation: Urology Group of Southern California
name: John Kowalczyk, DO, FACOS
role: PRINCIPAL_INVESTIGATOR
References: