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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.


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)


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Male.


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


- 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

Page last updated: August 23, 2015

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