Oral Testosterone for the Treatment of Hypogonadism in Males

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TesoRx Pharma, LLC
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.