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Androxal in Secondary Hypogonadism (ZA-003Ext)
NCT01067365Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2006
- Primary completion
- May 2007
- Countries
- 1
- Sponsor
- Repros Therapeutics Inc.
- Drugs
- enclomiphene
- Conditions
- secondary hypogonadism (HH)
01
Overview
Phase 3, open-label trial of enclomiphene in secondary hypogonadism (HH) (2 arms), sponsored by Repros Therapeutics Inc. Primary endpoint: Safety of Androxal at 1 year. Started Mar 2006; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
12.5 mg Androxal Arm
Subjects receive 12.5 mg Androxal daily for one year.
25 mg Androxal Arm
Subjects receive 25 mg Androxal daily for one year.
03
Who it enrols
Men with secondary hypogonadism who completed the ZA-003 study, with baseline testosterone < 300 ng/dL and no history of prostate cancer.
04
Endpoints
Primary
Safety of Androxal
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