Primary outcomeGeometric mean· Baseline and Week 52
Change From Baseline in Log-Transformed Testicular Volume at Week 52
| Group | Value (Fold change) |
|---|---|
| Corifollitropin Alfa 150 μg + hCG | 2.3 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA 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)
NCTNCT01709331 (opens ClinicalTrials.gov in a new tab)Other idP07937Other id2012-001258-25Other idMK-8962-031
This trial does not test a peptide that PepBank tracks.
- Names hCG (human chorionic gonadotropin), does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 18 participants (actual)
- Sponsor
- Organon and Co · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
- Not stated
- Start
- 11 Feb 2013
- Primary completion
- 8 Apr 2015
- Completion
- 8 Apr 2015
- First posted
- 18 Oct 2012 (estimated)
- Last update posted
- 24 May 2024
- Conditions
- Hypogonadism · Hypogonadotropic Hypogonadism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2013201420152016
- Ph 3
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)
NCT0170933111 Feb 2013 to 8 Apr 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Corifollitropin alfaDrug
- hCGDrug
Arms1
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Change From Baseline in Log-Transformed Testicular Volume at Week 52
Time frame · Baseline and Week 52
Registry description
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.
Percentage of Participants With Anti-Corifollitropin Alfa Antibodies
Time frame · Up to Week 57
Registry description
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.
Secondary outcomes(1)
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
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Up to Week 57
Percentage of Participants With Anti-Corifollitropin Alfa Antibodies
| Group | Value (Percentage of participants) |
|---|---|
| Corifollitropin Alfa 150 μg + hCG | 0 |
Secondary and other outcome results(1)
Secondary outcomeNumber· Up to Week 52
Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52
| Group | Value (Percentage of participants) |
|---|---|
| Corifollitropin Alfa 150 μg + hCG | 77.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Corifollitropin Alfa 150 μg + hCGDuring a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase. | – | 0 / 18 | 11 / 18 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Clinical trial · 2017
An open-label clinical trial to investigate the efficacy and safety of corifollitropin alfa combined with hCG in adult men with hypogonadotropic hypogonadism.
Nieschlag et al. 2017Reproductive biology and endocrinology : RB&Ecited by 30
PMID 28270212PMC5341390DOI 10.1186/s12958-017-0232-yPUB-28270212
CC BY
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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