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)

PHASE3CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

February 2, 2017

Primary Completion Date

May 5, 2020

Study Completion Date

May 5, 2020

Conditions
Hypogonadotropic Hypogonadism
Interventions
DRUG

Corifollitropin alfa

CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight \>60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).

DRUG

hCG

hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).

Trial Locations (15)

2100

Rigshospitalet, University department of Growth and Reproduction ( Site 0051), Copenhagen

50139

AOU Careggi ( Site 0042), Florence

117036

Federal State Budget Institution Endocrinological Research Center ( Site 0021), Moscow

191144

City children polyclinic #44 ( Site 0025), Saint Petersburg

194100

St.Petersburg State Pediatric Medical University ( Site 0023), Saint Petersburg

420048

Kazan State Medical University ( Site 0024), Kazan'

450106

Republic Children Clinical Hospital ( Site 0022), Ufa

80810-040

Centro de Diabetes Curitiba ( Site 0012), Curitiba

90035-903

Hospital de Clinicas de Porto Alegre ( Site 0014), Porto Alegre

05403-000

Hosp das Clinicas da Faculdade de Medicina da Univ de Sao Paulo ( Site 0015), São Paulo

00161

Policlinico Umberto I ( Site 0043), Roma

00165

IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0044), Roma

04530

Instituto Nacional de Pediatria ( Site 0007), Mexico City

06720

Hospital Infantil de Mexico Federico Gomez ( Site 0006), Mexico City

0181

Little Company of Mary Hospital ( Site 0017), Pretoria

All Listed Sponsors
lead

Organon and Co

INDUSTRY

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) | Biotech Hunter | Biotech Hunter