Clinical trial NCT01709331: 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)
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])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Hypogonadotropic Hypogonadism
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess if corifollitropin alfa (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.

Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Log-Transformed Testicular Volume at Week 52
timeFrame: Baseline and Week 52
measure: Percentage of Participants With Anti-Corifollitropin Alfa Antibodies
timeFrame: Up to Week 57
Secondary outcomes:
measure: Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52
timeFrame: Up to Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nieschlag E, Bouloux PG, Stegmann BJ, Shankar RR, Guan Y, Tzontcheva A, McCrary Sisk C, Behre HM. An open-label clinical trial to investigate the efficacy and safety of corifollitropin alfa combined with hCG in adult men with hypogonadotropic hypogonadism. Reprod Biol Endocrinol. 2017 Mar 7;15(1):17. doi: 10.1186/s12958-017-0232-y.