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

What Was Tested

The trial (phase 2) is built around Enclomiphene (non-peptide SERM).

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.

It had two arms (groups): Androxal (experimental) and Testim (topical testosterone) (active comparator).

The registry classes the interventions as drug.

Who Took Part

48 actual participants took part.

It was open to men only aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: any condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Enclomiphene (non-peptide SERM) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Enclomiphene (non-peptide SERM) study: the participants and staff both knew the treatment.

It started in 2011-07 with completion listed for 2013-01.

It ran at 8 sites in United States (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in testosterone comparing Androxal to Testim (time frame: 1 year).

It also tracked 2 secondary outcomes, for example Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) and Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Enclomiphene (non-peptide SERM) in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Enclomiphene (non-peptide SERM) compound page, all human trials.