Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism

What Was Tested

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

To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.

It had two arms (groups): Androxal (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting.

Results will be compared to an age-matched placebo group.

Who Took Part

Enrollment: 300 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.

Examples of who could join: Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1. LH \<9.4 mIU/mL (at Visit 1 only). Ability to complete the study in compliance with the protocol. Ability to understand and provide written informed consent.

The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: 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; known hypersensitivity to clomid.

How the Study Was Run

The set-up was non-randomized, parallel-group and single-blind.

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 2012-09 with completion listed for 2014-09.

It ran at 17 sites in United States (17).

What Was Measured

The main thing measured (primary outcome): Bone Mineral Density (time frame: 52 weeks).

It also tracked 1 secondary outcome, for example Testosterone.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Enclomiphene (non-peptide SERM) in 300 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.