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A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01386567
First received: June 29, 2011
Last updated: May 16, 2013
Last verified: May 2013

June 29, 2011
May 16, 2013
July 2011
January 2013   (final data collection date for primary outcome measure)
Change in testosterone comparing Androxal to Testim [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Same as current
Complete list of historical versions of study NCT01386567 on ClinicalTrials.gov Archive Site
  • Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
  • Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
Same as current
Not Provided
Not Provided
 
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypogonadism
  • Low Testosterone
  • Drug: Androxal (enclomiphene citrate)

    capsules oral 1x a day

    1 year

    Other Name: enclomiphene citrate
  • Drug: Testim (topical testosterone)

    topical

    1 tube

    1x a day

    1 year

    Other Names:
    • topical testosterone
    • exogenous testosterone
    • testosterone gel
  • Experimental: Androxal
    Androxal (enclomiphene citrate)12.5 mg or 25 mg
    Intervention: Drug: Androxal (enclomiphene citrate)
  • Active Comparator: Testim (topical testosterone)
    Intervention: Drug: Testim (topical testosterone)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of ZA-203
  • Ability to understand and provide written informed consent
  • Agreement to use a condom, and with a fertile female partner, another form of contraception
  • Agreement to provide semen samples in the clinic

Exclusion Criteria:

  • Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Male
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01386567
ZA-203 Extension
No
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Not Provided
Repros Therapeutics Inc.
May 2013

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