To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Summary
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-07
- Completion
- 2009-08
Outcome
Mixed primary results
registry MEAN Group A Testim: Month 3: 3.00 (Standard Deviation 5.20) millions sperm/mL NCT00706719 ↗
registry MEAN Group B Androxal no Wash Out: Month 3: 182.6 (Standard Deviation 115.5) millions sperm/mL NCT00706719 ↗
registry analysis (superiority or other test); Group A Testim vs Group B Androxal no Wash Out; p = 0.006; t-test, 2 sided NCT00706719 ↗
registry analysis (superiority or other test); Group A Testim vs Group B Androxal no Wash Out; p = 0.054; t-test, 2 sided NCT00706719 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Androxal | Unknown | 25 mg | Oral |
| Comparator | Testosterone | Small molecule | 1 % | Topical |