Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism (ZA-003Ext)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067365
First received: February 10, 2010
Last updated: June 26, 2014
Last verified: June 2014

February 10, 2010
June 26, 2014
March 2006
May 2007   (final data collection date for primary outcome measure)
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01067365 on ClinicalTrials.gov Archive Site
Not Provided
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® [ Time Frame: Six months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hypogonadism
  • Drug: Androxal
    12.5 mg once daily
    Other Name: Enclomiphene citrate
  • Drug: Androxal
    25 mg once daily
    Other Name: Enclomiphene citrate
  • Experimental: 12.5 mg Androxal
    12.5 mg Androxal daily
    Intervention: Drug: Androxal
  • Experimental: 25 mg Androxal
    25 mg Androxal daily
    Intervention: Drug: Androxal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
May 2007
May 2007   (final data collection date for primary outcome measure)

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.

Male
18 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01067365
ZA-003 Extension Study
No
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP