Clinical trial NCT02222558: Oral Testosterone for the Treatment of Hypogonadism in Males
Official title: A Phase 2B Study to Determine the Dose Response Pharmacokinetics of TSX-002 (Testosterone) in Hypogonadal Males
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,
Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anabolic Agents
dihydrotestosterone
Lead sponsor: TesoRx Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Responders
timeFrame: Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
Study officials:
affiliation: San Diego Sexual Medicine
name: Irwin Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: