Phase 2
N=25
Oral Testosterone for the Treatment of Hypogonadism in Males
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02222558 ↗Enrolled (actual)
25
Serious AEs
1.5%
Results posted
May 2016
Primary outcome: Primary: Percentage of Responders — 67; 57; 50; 100 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TSX-002 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- TesoRx Pharma, LLC
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders |
67; 57; 50; 100; 25; 57.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Symptomatic hypogonadal male subjects (Testosterone > 100 and 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.
Data sourced from ClinicalTrials.gov (NCT02222558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.