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)
NCT01709331, Phase 3, Completed, Organon and Co; results first posted 2016-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT01709331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT01709331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypogonadism, Hypogonadotropic Hypogonadism
- Interventions
- Corifollitropin alfa, hCG
- First posted
- 2012-10-18
- Last updated
- 2024-05-24
- Other registries' IDs
- eudract:2012-001258-25
- Results first posted
- 2016-05-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Log-Transformed Testicular Volume at Week 52 | 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. |
| Primary | Percentage of Participants With Anti-Corifollitropin Alfa Antibodies | 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. |
| Secondary | Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Log-Transformed Testicular Volume at Week 52 | Baseline and Week 52 | Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume. | Fold change | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Anti-Corifollitropin Alfa Antibodies | Up to Week 57 | All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52 | Up to Week 52 | FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Log-Transformed Testicular Volume at Week 52 | Corifollitropin Alfa 150 μg + hCG | 2.3 | 95% Confidence Interval 2.03 to 2.62 | Fold change | |
| Percentage of Participants With Anti-Corifollitropin Alfa Antibodies | Corifollitropin Alfa 150 μg + hCG | 0 | 52.4 to 93.6 | Percentage of participants | |
| Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52 | Corifollitropin Alfa 150 μg + hCG | 77.8 | 95% Confidence Interval 52.4 to 93.6 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Corifollitropin Alfa 150 μg + hCG | 18 | |
| Overall Study | COMPLETED | Corifollitropin Alfa 150 μg + hCG | 17 | |
| Overall Study | NOT COMPLETED | Corifollitropin Alfa 150 μg + hCG | 1 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Haemorrhoids | Gastrointestinal disorders | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Seasonal allergy | Immune system disorders | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Conjunctivitis | Infections and infestations | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Nasopharyngitis | Infections and infestations | Corifollitropin Alfa 150 μg + hCG | 4 | 18 | 5 |
| other | Blood pressure increased | Investigations | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
| other | Blood testosterone increased | Investigations | Corifollitropin Alfa 150 μg + hCG | 2 | 18 | 2 |
| other | Oestradiol increased | Investigations | Corifollitropin Alfa 150 μg + hCG | 3 | 18 | 4 |
| other | Testicular scan abnormal | Investigations | Corifollitropin Alfa 150 μg + hCG | 1 | 18 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Corifollitropin Alfa 150 μg + hCG | ||
| Total, other adverse events | Corifollitropin Alfa 150 μg + hCG | 11 | 18 |
| Total, serious adverse events | Corifollitropin Alfa 150 μg + hCG | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28270212 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01709331
GET https://conductscience.org/api/trials/v1/NCT01709331/registered