Phase 2
N=17
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Secondary Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT00706719 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Sperm Concentration — 0.54; 72.8; 3.00; 182.6 millions sperm/mL — p=0.118
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 25 mg Androxal (Drug); Testim 1% (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- Repros Therapeutics Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sperm Concentration |
0.54; 72.8; 3.00; 182.6; 23.14; 168.5 | 0.118 |
| PRIMARY Motile Total Sperm Count |
0.3; 99.0; 2.42; 214.7; 40.4; 146.9 | 0.15 |
| PRIMARY Semen Volume |
2.34; 2.23; 2.88; 2.45; 1.90; 2.48 | 0.880 |
| SECONDARY Luteinizing Hormone (LH) Levels |
3.40; 2.92; 0.88; 5.70; 0.60; 6.12 | 0.705 |
| SECONDARY Follicle Stimulating Hormone (FSH) Levels |
3.38; 1.58; 1.06; 4.53; 0.9; 5.48 | 0.008 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
- Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.
Exclusion Criteria
- A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
- Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
- Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
- Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl
Data sourced from ClinicalTrials.gov (NCT00706719). 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.