Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

What Was Tested

The trial (phase 3) is built around Enclomiphene (non-peptide SERM).

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Who Took Part

The registry lists 499 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Secondary hypogonadal males between the ages of 18 and 65. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level \< 350 ng/dL for men age \< 55 and \< 300ng/dl for men age 55-65. LH \< 15mIU/mL (at Visit 1 only). Ability to complete the study in compliance with the protocol.

The full record lists 7 inclusion and 20 exclusion criteria; among the exclusions: use of clomid in the past year; uncontrolled hypertension based on the investigator's assessment at baseline. subjects treated for type ii diabetes will be allowed into the study; use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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 2012-05 with completion listed for 2013-10.

It ran at 31 sites in United States (31).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Total Morning Testosterone at 26 Weeks (time frame: 6 months). Change From Baseline in LH (time frame: 6 months). Absolute Values of Morning Testosterone (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Enclomiphene (non-peptide SERM) in 499 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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