Trial · Interventional
CompletedPhase 3Registry dataStudy to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
Short name ZA-003Ext
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 104 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2006
- Primary completion
- May 2007
- Completion
- May 2007
- First posted
- 11 Feb 2010 (estimated)
- Last update posted
- 27 Jun 2014 (estimated)
- Conditions
- Secondary Hypogonadism
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
Interventions
- AndroxalDrug
- AndroxalDrug
Arms2
Experimental
12.5 mg Androxal
12.5 mg Androxal daily
Experimental
25 mg Androxal
25 mg Androxal daily
Primary outcomes1
Outcomes the sponsor listed as primary.
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time frame · One year
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 68 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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