Effects of Medications in Patients With Hypogonadism

What Was Tested

In this phase 4 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had two arms (groups): hypogonadism, treatment (other) and Control group (no intervention).

77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin.

42 healthy controls.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 119 actual participants took part.

It was open to men only aged from 18 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: FSH and LH levels within or below the normal range,. Normal smell test and normal karyotypes.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: previous androgen treatment,; history of smoking,; presence of bilateral anorchia,.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the hCG (human chorionic gonadotropin) group and the comparison group should start out alike.

Each person switched between hCG (human chorionic gonadotropin) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label hCG (human chorionic gonadotropin) study: the participants and staff both knew the treatment.

It started in 2008-01 with completion listed for 2012-03.

It ran at 2 sites in Turkey (Türkiye) (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured (time frame: 3 years). Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured (time frame: 3 years). Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured (time frame: 3 years).

It also tracked 3 secondary outcomes, for example Effect of testosterone enanthate on testis volumes, Effect of testosterone gel on testis volumes and Effect of human chorionic gonadotrophin on testis volumes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of hCG (human chorionic gonadotropin) in 119 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.