Androxal in Male Infertility

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Enclomiphene (non-peptide SERM).

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause.

Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio.

It had two arms (groups): Arm 1(IP) (experimental) and Arm 2 (Placebo) (placebo comparator).

Placebo capsule 1x daily for 16 weeks.

The registry classes the interventions as drug and other.

More on the Plan

There are many reasons for the low number of men receiving testosterone replacement therapy, one of which is the route of administration.

The currently approved androgen therapies are oral products, injectables, patches, buccal systems, and gels, and each has disadvantages.

Patches may require intrusive preparation, cause skin irritation or not adhere properly.

A testosterone gel has overcome some of the above problems and has gained acceptance, but there are indications that men do not apply the gel correctly.

Who Took Part

It was open to men only aged from 18 years up to 35 years.

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

The full record lists 7 inclusion and 21 exclusion criteria; among the exclusions: patients having received an investigational drug / clomiphene citrate, antioxidants, multi-vitamin in the past 30 days prior to study; known hypersensitivity to clomiphene citrate; current or history of breast cancer.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Enclomiphene (non-peptide SERM).

Those kept unaware of assignments: participant and investigator.

It started in 2014-09-22 with completion listed for 2016-08-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Doubling of total motile sperm count (time frame: 16 weeks).

It also tracked 3 secondary outcomes, for example Morning hormone levels, Changes in questionnaire responses and BMI.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Enclomiphene (non-peptide SERM) in people.

It was withdrawn before enrolling anyone; 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.