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) - Full Text View

Purpose

This study will assess if MK-8962, when administered in combination with human chorionic gonadotropin (hCG) will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone.

Condition	Intervention	Phase
Hypogonadism Hypergonadotropic Hypogonadism	Drug: MK-8962 Drug: hCG	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III, Multi-center, Open Label, Uncontrolled Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) in Inducing Increased Testicular Volume and Spermatogenesis in Adult Men With Hypogonadotropic Hypogonadism Who Remain Azoospermic When Treated With hCG Alone (Phase III; Protocol No. MK-8962-031-00 [Also Known as SCH 900962, P07937])

Resource links provided by NLM:

Drug Information available for: Chorionic Gonadotropin Choriogonadotropin Alfa

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from Baseline in Log-transformed Testicular Volume [ Time Frame: Baseline (Day 1) and Week 52 ] [ Designated as safety issue: No ]
Percentage of Participants with anti-MK-8962 Antibodies [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of Participants with Induced Spermatogenesis Resulting in a Sperm Count ≥ 1x10^6/mL [ Time Frame: up to 52 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	February 2013
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-8962 MK-8962 to be injected once every other week in the morning in accordance with the hCG administration scheduled and dependent on individual participant's preference	Drug: MK-8962 MK-8962, 150 μg corifollitropin alfa per 0.5 mL subcutaneous (SC) injection, once every 2 weeks for 52 weeks Drug: hCG Pre-treatment Phase (16 weeks): 1500 international units (IU) of hCG by SC injection, twice a week. May be uptitrated to 3000 IU hCG twice a week after 8 weeks if insufficient response. Treatment Phase (52 weeks) at dose level that induced a sufficient response during pre-treatment phase.

Arms

Assigned Interventions

Experimental: MK-8962

MK-8962 to be injected once every other week in the morning in accordance with the hCG administration scheduled and dependent on individual participant's preference

Drug: MK-8962

MK-8962, 150 μg corifollitropin alfa per 0.5 mL subcutaneous (SC) injection, once every 2 weeks for 52 weeks

Drug: hCG

Pre-treatment Phase (16 weeks): 1500 international units (IU) of hCG by SC injection, twice a week. May be uptitrated to 3000 IU hCG twice a week after 8 weeks if insufficient response. Treatment Phase (52 weeks) at dose level that induced a sufficient response during pre-treatment phase.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Caucasian
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)
Adequate replacement of other pituitary hormones
Good general physical and mental health

Exclusion Criteria:

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
Treated with FSH, hCG or gonadotropin-releasing hormone (GnRH) within previous 3 months or for more than 1 month within previous 6 months
Proven spermatogenesis with hCG treatment alone
Previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis
Required a dose of hCG of more than 6000 international units (IU) per week in a previous attempt to normalize T levels
Untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the study
History or presence (known or suspected) of testicular, prostatic or breast cancer
Prostate pathology of clinical importance
Past or present oncologic treatment (chemo/radiotherapy)
Diabetes mellitus
Clinically significant, untreated hyperprolactinaemia
Uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
Tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
User of recreational or illicit drugs or has had a recent history (within the past year) of drug abuse or dependence, or increased alcohol consumption
Allergy/sensitivity to gonadotropins or its/their excipients
Has received within previous 1 month or plans to use: Hormonal preparations other than the study medication, drugs that are known to impair testicular function, agents known to affect sex hormone secretion and/or drugs that are known or suspected to be teratogenic
Used any investigational drugs within three months or actively participating in another study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709331

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

Australia
Merck Sharp & Dohme	Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz 61 2 8988 8246
Germany
Merck Sharp & Dohme GmbH	Recruiting
Haar, Germany
Contact: Kristian Lobner 49 89 4561 1102
Italy
MSD Italia S.r.l.	Recruiting
Rome, Italy
Contact: Patrizia Nardini 39 06 361911
Poland
MSD Polska Sp. Z o.o.	Recruiting
Warsaw, Poland
Contact: Adam Czernik 48 22 4784324
Spain
Merck Sharp and Dohme de Espana S.A.	Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez 34 913210600
United Kingdom
Merck Sharp & Dohme Ltd.	Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson 44 1992452396

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01709331 History of Changes
Other Study ID Numbers:	P07937, 2012-001258-25, MK-8962-031
Study First Received:	October 16, 2012
Last Updated:	May 16, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013