Clinical Trials Logo
  1. Home
  2. Hypogonadotropic Hypogonadism
  3. NCT03019575

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)

Hypogonadotropic Hypogonadism Clinical Trial

Official title:
A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

Clinical Trial Summary

The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to <18. 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03019575
Study type Interventional
Source Organon and Co
Contact
Status Completed
Phase Phase 3
Start date February 2, 2017
Completion date May 5, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT01438073 - Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling Phase 1
Completed NCT01403532 - Sequential Therapy for Hypogonadotropic Hypogonadism Phase 4
Recruiting NCT00456274 - Baselines in Reproductive Disorders N/A
Terminated NCT05205837 - A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial Phase 4
Completed NCT02908074 - A 6 Month Safety Extension Study of MBGS205 Phase 2
Completed NCT05752591 - Hypothalamic-pituitary Dysfunction in Diabetes
Terminated NCT03118479 - Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH) Phase 1
Completed NCT02730169 - Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism Phase 2
Completed NCT02110368 - Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions Phase 3
Recruiting NCT01601171 - Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
Completed NCT01623570 - Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP N/A
Terminated NCT00328926 - Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L]) Phase 4
Completed NCT01438034 - Kisspeptin in the Evaluation of Delayed Puberty Phase 1
Completed NCT04456296 - A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Phase 4
Recruiting NCT00914823 - Kisspeptin Administration in the Adult Phase 1
Terminated NCT01155518 - Hypogonadism in Young Men With Type 2 Diabetes Phase 2
Completed NCT00697814 - Clomiphene in Males With Prolactinomas and Persistent Hypogonadism Phase 2
Active, not recruiting NCT00351416 - Letrozole Treatment in Normal and GnRH Deficient Women Phase 2/Phase 3
Recruiting NCT05971836 - The Molecular Basis of Inherited Reproductive Disorders
Recruiting NCT02705014 - Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome N/A