NCT01067365CompletedPhase 3
An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Repros Therapeutics Inc.
- Enrollment
- 104
- Locations
- 18
- Primary Endpoint
- Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Study Overview
Brief Summary
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
Detailed Description
The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 68 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Total serum testosterone concentrations < 300 ng/dL at baseline
Exclusion Criteria
- •Presence or history of prostate cancer
- •Elevated PSA > 3.5 ng/mL
- •Additional inclusion and exclusion criteria may apply.
Arms & Interventions
12.5 mg Androxal
Experimental
12.5 mg Androxal daily
Intervention: Androxal (Drug)
25 mg Androxal
Experimental
25 mg Androxal daily
Intervention: Androxal (Drug)
Outcomes
Primary Outcomes
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time Frame: One year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (18)
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