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

Completed · Phase 2

Conditions studied: Hypogonadism, Low Testosterone

In brief

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.

Key facts

Study ID

NCT01386567

Run by

Repros Therapeutics Inc.

People needed

48

Starts

2011-07-01

Expected to finish

2013-01-01

Last updated by the study team

2013-05-17

Who can join

Age: 21 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Where it is running

• Study site — Garden Grove, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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