Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067365
First received: February 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 10, 2010
February 10, 2010
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: Six months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

Not Provided
Interventional
Phase 3
Allocation: 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
  • Drug: AndroGel
    5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert
  • Drug: Placebo
    1 capsule daily
    Other Name: Placebo
  • Experimental: 1
    Androxal™
    Intervention: Drug: Androxal
  • Experimental: 2
    Androxal™
    Intervention: Drug: Androxal
  • Active Comparator: 3
    AndroGel®
    Intervention: Drug: AndroGel
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
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
Andre van As, MD, PhD, Repros Therapeutics, Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
February 2010

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