- ICH GCP
- US Clinical Trials Registry
- 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)
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])
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Corifollitropin alfa 150 μg + hCG
During a 16-week pretreatment phase, participants will receive twice-weekly subcutaneous (SC) injections of hCG 1500 or 3000 international units (IU).
Eligible participants will then be enrolled in the combined treatment phase in which they will receive a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks.
In addition, eligible participants will continue to receive twice-weekly hCG injections on the same schedule as the pretreatment phase.
|
Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks
Other Names:
hCG 1500 or 3000 IU by SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and then in combination with corifollitropin alfa for 52 weeks (combined treatment phase)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Log-Transformed Testicular Volume at Week 52
Time Frame: Baseline and Week 52
|
Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
The testicular volume was measured as the sum of volumes of left and right testes.
The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant.
For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated.
The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.
|
Baseline and Week 52
|
Percentage of Participants With Anti-Corifollitropin Alfa Antibodies
Time Frame: Up to Week 57
|
Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.
|
Up to Week 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52
Time Frame: Up to Week 52
|
Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.
|
Up to Week 52
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P07937
- 2012-001258-25 (EudraCT Number)
- MK-8962-031 (Other Identifier: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypogonadotropic Hypogonadism
-
Shanghai Jiao Tong University School of MedicineUnknownIdiopathic Hypogonadotropic Hypogonadism
-
Fudan UniversityRecruitingIdiopathic Hypogonadotropic Hypogonadism | Luteal Phase Support | Luteal Phase DeficiencyChina
-
Azienda Ospedaliero-Universitaria di ModenaRecruitingAcquired Hypogonadotropic HypogonadismItaly
-
Repros Therapeutics Inc.CompletedObesity | Acquired Hypogonadotropic HypogonadismUnited States
-
Massachusetts General HospitalTerminatedHypothalamic Amenorrhea | Idiopathic Hypogonadotropic HypogonadismUnited States
-
Ferring PharmaceuticalsCompletedPrimary Amenorrhea With Hypogonadotropic HypogonadismUnited States, Canada
-
Endo PharmaceuticalsCompletedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleUnited States
-
Rigshospitalet, DenmarkTerminatedHypogonadotropic Hypogonadism | Hypogonadism | Hypogonadism, MaleDenmark
-
Amneal Pharmaceuticals, LLCPhase One Solutions, Inc.CompletedHypogonadotropic Hypogonadism | Primary HypogonadismUnited States
-
Huashan HospitalRecruitingHypogonadotropic HypogonadismChina
Clinical Trials on Corifollitropin alfa
-
Organon and CoCompleted
-
University of Turin, ItalyCompleted
-
Universitair Ziekenhuis BrusselCompleted
-
Institut Universitari DexeusCompleted
-
Organon and CoCompleted
-
Shin Kong Wu Ho-Su Memorial HospitalUnknown
-
Azienda Ospedaliero-Universitaria di ModenaRecruiting
-
Instituto BernabeuCompletedImproving Ovarian Stimulation; Suboptimal RespondersSpain
-
Aristotle University Of ThessalonikiCompleted
-
Institut Universitari DexeusFrancisca Martínez; Buenaventura Coroleu; Elisabet Clua; Ignacio RodríguezCompleted