Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)

What Was Tested

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

In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies.

No formal hypothesis will be tested for this estimation study.

It had 1 arm (groups): Corifollitropin alfa (CFA)+human Chorionic Gonadotropin (hCG) (experimental).

The registry classes the interventions as drug.

Who Took Part

17 actual participants took part.

It was open to men only aged from 14 years up to 17 years.

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

The full record lists 3 inclusion and 21 exclusion criteria; among the exclusions: have a history of bilateral cryptorchidism (maldescended testes) or unilateral cryptorchidism treated after the age of 2 years; has an untreated or inadequately treated pituitary or hypothalamic tumor; have uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary disorders not on stable replacement therapies.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2017-02-02 with completion listed for 2020-05-05.

It ran at 15 sites in Russia (5), Brazil (3), Italy (3), Mexico (2), Denmark (1) and South Africa (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 (time frame: Baseline and Week 64). Number of Participants Who Experienced an Adverse Event (AE) (time frame: Up to approximately 71 Weeks). Number of Participants Who Discontinued Study Treatment Due to an AE (time frame: Up to approximately 64 Weeks).

It also tracked 13 secondary outcomes, for example Change From Baseline in Serum Inhibin B Concentration to Week 64, Growth Velocity at Week 36, Growth Velocity at Week 64, Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64, Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 and Mean Serum Concentration of CFA.

What This Means in Plain Language

Put simply, this is a phase 3 trial of hCG (human chorionic gonadotropin) in 17 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.