The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

What Was Tested

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

It had four arms (groups): one (experimental), one (experimental), one (experimental) and AndroGel (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study will require 7 visits, which includes 2 overnight stays in a clinic.

One visit is an eye exam.

Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays.

A six month extension study will be available for all subjects completing the 6-week study.

Who Took Part

Enrollment: 60 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: Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL. Ability to complete the study in compliance with the protocol. 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 a semen sample in the clinic.

The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study; use of clomid in the past year or during 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

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

The participants were allocated by chance, so the Enclomiphene (non-peptide SERM) group and the comparison group should start out alike.

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

In this single-blind Enclomiphene (non-peptide SERM) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-06 with completion listed for 2011-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 24 Hour Average and Maximum Testosterone Concentration (time frame: Baseline and Week 6).

It also tracked 2 secondary outcomes, for example Change in Leuteinizing Hormone (LH) and Change in Follicle Stimulating Hormone (FSH).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Enclomiphene (non-peptide SERM) in 60 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.