A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
Information source: Repros Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism; Low Testosterone
Intervention: Androxal (enclomiphene citrate) (Drug); Testim (topical testosterone) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Repros Therapeutics Inc.
Summary
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.
Clinical Details
Official title: A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in testosterone comparing Androxal to Testim
Secondary outcome: Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Garden Grove, California 92844, United States
Sacramento, California 95821, United States
San Diego, California 92108, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89144, United States
Houston, Texas 77024, United States
Houston, Texas 77062, United States
Houston, Texas 77095, United States
Additional Information
Sponsor website Study information
Starting date: July 2011
Last updated: May 16, 2013
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