Trials / Completed
CompletedNCT01386567
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Sex
- Male
- Age
- 21 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Androxal (enclomiphene citrate) | capsules oral 1x a day 1 year |
| DRUG | Testim (topical testosterone) | topical 1 tube 1x a day 1 year |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-07-01
- Last updated
- 2013-05-17
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01386567. Inclusion in this directory is not an endorsement.