Status:
COMPLETED
Oral Testosterone for the Treatment of Hypogonadism in Males
Lead Sponsor:
TesoRx Pharma, LLC
Conditions:
Hypogonadism
Eligibility:
MALE
18-70 years
Phase:
PHASE2
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 ...
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02222558
Start Date
September 1 2014
End Date
May 1 2015
Last Update
May 30 2016
Active Locations (1)
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1
San Diego Sexual Medicine
San Diego, California, United States, 92120