Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

What Was Tested

In this phase 3 trial, researchers set out to test Enclomiphene (non-peptide SERM).

The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo.

Subjects must not have previously been treated with testosterone products within the last 6 months.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Placebo oral capsules taken one time daily.

The registry classes the interventions as drug.

More on the Plan

Protocol ZA-302 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study to evaluate normalization of morning testosterone levels in overweight men with acquired hypogonadotropic hypogonadism and normal baseline sperm concentrations.

The study requires 10 to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration.

Subjects will be treated for 12-18 weeks.

Placebo subjects may be sham titrated.

Who Took Part

Enrollment: 181 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

The full record lists 8 inclusion and 28 exclusion criteria; among the exclusions: any prior use of testosterone treatments within the last 6 months; use of clomid in the past year; 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: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Enclomiphene (non-peptide SERM) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Enclomiphene (non-peptide SERM), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-11 with completion listed for 2013-09.

It ran at 13 sites in United States (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Subjects With Testosterone in Normal Range After Treatment (time frame: 3 months). Change in Sperm Concentration (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Enclomiphene (non-peptide SERM) in 181 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.