A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)

What Was Tested

This registered phase 3 trial tested hCG (human chorionic gonadotropin).

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 18 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Diagnosed with hypogonadotropic hypogonadism, either congenital or acquired. Have low circulating levels of testosterone. Have low circulating levels of gonadotropins (follicle stimulating hormone \[FSH\]; luteinizing hormone). Presence of both scrotal testes. Have azoospermia (no measurable level of sperm).

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: primary hypogonadism, such as klinefelter's syndrome; history of unilateral or bilateral cryptorchidism (maldescended testes); history or presence of testicular pathology of clinical importance (e.g., epididymitis, orchitis, testicular torsion, varicocele stage iii, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-02-11 with completion listed for 2015-04-08.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Log-Transformed Testicular Volume at Week 52 (time frame: Baseline and Week 52). Percentage of Participants With Anti-Corifollitropin Alfa Antibodies (time frame: Up to Week 57).

It also tracked 1 secondary outcome, for example Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52.

What This Means in Plain Language

Put simply, this is a phase 3 trial of hCG (human chorionic gonadotropin) in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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