Trial · NCT03019575
Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
NCT03019575, Phase 3, Completed, Organon and Co; results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043). Trials, record NCT03019575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03019575
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
- NCT number
- NCT03019575
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 17 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypogonadotropic Hypogonadism
- Interventions
- Corifollitropin alfa, hCG
- First posted
- 2017-01-12
- Last updated
- 2024-05-23
- Other registries' IDs
- eudract:2015-001878-18
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes17
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 (TV) to Week 64 | Baseline and Week 64 | Participants underwent testicular ultrasound of left and right testes at pre-specified time points to measure TV. TV was measured as the sum of volumes of left and right testes. The linear mixed model with a fixed effect for baseline and Week 64 and a random effect for participant was used to calculate the mean change in log-transformed TV and associated 95% confidence intervals (CIs) from baseline to Week 64. The geometric mean ratio and its 95% CIs for TV were obtained by exponentiation. The ratio \> 1 indicated an increase in TV from baseline. |
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 71 Weeks | An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was reported. |
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 64 Weeks | An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE was reported. |
| Primary | Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies | Up to approximately 71 Weeks | Blood samples were collected at pre-specified time points to assess anti-CFA antibodies. The percentage of participants with anti-CFA antibodies after administration of CFA were reported. |
| Secondary | Change From Baseline in Serum Inhibin B Concentration to Week 64 | Baseline and Week 64 | Serum Inhibin B concentration is a surrogate marker for spermatogenesis in males. Blood samples were collected at baseline and Week 64 post dose to report the mean change from baseline in serum inhibin concentration to Week 64. A mean change from baseline in serum inhibin B concentration to Week 64 was reported. A positive value indicated a higher serum inhibin concentration level. |
| Secondary | Growth Velocity at Week 36 | Week 36 | Growth velocity is the rate of change in height measurement and is a marker for pubertal progress. Height was measured using a wall-mounted calibrated stadiometer. A mixed model was used to assess the overall growth velocity slope over the 36-week treatment period using the slopes estimated from an overall mixed random intercept and random slope model of height (cm) and time (yr) and age as covariates. |
| Secondary | Growth Velocity at Week 64 | Week 64 | Growth velocity is the rate of change in height measurement and is a marker for pubertal progress. Height was measured using a wall-mounted calibrated stadiometer. A mixed model was used to assess the overall growth velocity slope over the 64-week treatment period using the slopes estimated from an overall mixed random intercept and random slope model of height (cm) and time (year) and age as covariates. |
| Secondary | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | Male participants were assessed clinically for pubertal development using the TS for pubic hair (range: Tanner I-V). TS describes sexual maturity stages (no better or worse outcome) as: Tanner I: prepubertal state, Tanner II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum, Tanner III: hair becomes more coarse and curly, and begins to extend laterally, Tanner IV: adult-like hair quality, extending across pubis but sparing medial thighs and Tanner V: hair extends to medial surface of the thigh. The number of participants in each Tanner stage at baseline and categorical change from baseline in Tanner stages to Weeks 12, 36 and 64 were reported. |
| Secondary | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | Male participants were assessed clinically for pubertal development using TS for genital growth (range: Tanner I-V). TS describes sexual maturity stages (no better or worse outcome) as: Tanner I: prepubertal (TV \<1.5 ml; small penis), Tanner II: TV 1.6-6ml; skin on scrotum thins, reddens and enlarges; penis length unchanged, Tanner III: TV 6-12ml; scrotum enlarges further; penis begins to lengthen Tanner IV: TV 12-20ml; scrotum enlarges further and darkens; penis increases in length and circumference, and Tanner V: TV \>20ml; adult scrotum and penis. The number of participants in each Tanner stage at baseline and categorical change from baseline in Tanner stages to Weeks 12, 36 and 64 were reported. |
| Secondary | Mean Serum Concentration of CFA | Day 1: predose, 6-24 hours postdose; Day 3: 32-52 hours postdose; Day 5: 72-120 hours postdose; Day 8: 144-192 hours postdose; Day 11: 216-244 hours postdose; Days 29, 85, 169, 253, 337: predose; Days 449, 456: postdose | Blood samples were collected at pre-specified time points (Day 1 (predose, 6-24 hours postdose after 1st dose), Day 3 (32-52 hours postdose after 1st dose), Day 5 (72-120 hours postdose after 1st dose), Day 8 (144-192 hours postdose after 1st dose), Day 11 (216-244 hours postdose after 1st dose), Day 29 (predose prior to 2nd dose; no hCG), Day 85 (predose, prior to 4th dose; no hCG), Day 169 (predose prior to 7th dose; with hCG co-administration), Day 253 (predose prior to 10th dose with hCG co-administration), Day 337 (predose prior to 13th dose; with hCG co-administration), Days 449 and 456 (postdose)) to report the mean serum concentration of CFA. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 (TV) to Week 64 | Baseline and Week 64 | All participants who received at least 1 dose of study treatment, who had a baseline and at least 1 post baseline TV value, had luteinizing hormone (LH) level ≤3 IU/L anytime in the study, had at least 12 weeks of Corifollitropin Alfa (CFA) and 24 weeks of CFA plus human chorionic gonadotropin (hCG) treatment, have last TV value within 4 weeks from last dose of CFA were analyzed. | mL | MEAN |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 71 Weeks | All participants who received at least 1 dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 64 Weeks | All participants who received at least 1 dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies | Up to approximately 71 Weeks | All participants who received at least 1 dose of study treatment were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Serum Inhibin B Concentration to Week 64 | Baseline and Week 64 | All participants who received at least 1 dose of study treatment who had a baseline and at least 1 post baseline TV value, had LH level ≤3 IU/L anytime in the study, had at least 12 weeks of CFA and 24 weeks of CFA plus hCG treatment, have last TV value within 4 weeks from last dose of CFA and had a baseline and at least 1 post baseline inhibin value were analyzed. | ng/L | MEAN |
| SECONDARY | Growth Velocity at Week 36 | Week 36 | All participants who received at least 1 dose of study treatment, had a baseline and at least 1 post baseline TV value, had LH level ≤3 IU/L anytime in the study, had at least 12 weeks of CFA and 24 weeks of CFA plus hCG treatment, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline height records at Week 36 were analyzed. | cm/year | LEAST_SQUARES_MEAN |
| SECONDARY | Growth Velocity at Week 64 | Week 64 | All participants who received at least 1 dose of study treatment, had a baseline and at least 1 post baseline TV value, had LH level ≤3 IU/L anytime in the study, had at least 12 weeks of CFA and 24 weeks of CFA plus hCG treatment, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline height records at Week 64 were analyzed. | cm/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | All participants who received at least 1 dose of study treatment who had a baseline and at least 1 post baseline TV value, had LH level ≤3 IU/L anytime in the study, had at least 12 weeks of CFA and 24 weeks of CFA plus hCG treatment, have last TV value within 4 weeks from last dose of CFA were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | All participants who received at least 1 dose of study treatment who had a baseline and at least 1 post baseline TV value, had LH level ≤3 IU/L anytime in the study, had at least 12 weeks of CFA and 24 weeks of CFA plus hCG treatment, have last TV value within 4 weeks from last dose of CFA were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Concentration of CFA | Day 1: predose, 6-24 hours postdose; Day 3: 32-52 hours postdose; Day 5: 72-120 hours postdose; Day 8: 144-192 hours postdose; Day 11: 216-244 hours postdose; Days 29, 85, 169, 253, 337: predose; Days 449, 456: postdose | All enrolled participants in the study were analyzed. | ng/L | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group100
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 (TV) to Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Baseline | 1.5 | Standard Deviation 0.7 | mL |
| Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Week 64 | 14.5 | Standard Deviation 6.8 | mL |
| Number of Participants Who Experienced an Adverse Event (AE) | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 16 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | Participants | ||
| Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 0 | Percentage of Participants | ||
| Change From Baseline in Serum Inhibin B Concentration to Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Baseline | 31.92 | Standard Deviation 35.30 | ng/L |
| Change From Baseline in Serum Inhibin B Concentration to Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Baseline to Week 64 | 91.46 | Standard Deviation 59.25 | ng/L |
| Growth Velocity at Week 36 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 8.3 | Standard Error 1.1 | cm/year | |
| Growth Velocity at Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 7.6 | Standard Error 1.0 | cm/year | |
| Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Baseline (BL) Tanner I | 6 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 17 | |
| Overall Study | COMPLETED | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 17 | |
| Overall Study | NOT COMPLETED | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 0 |
Source ClinicalTrials.gov
Adverse events53
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 | Anaemia | Blood and lymphatic system disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Hydrocele | Congenital, familial and genetic disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Hypothyroidism | Endocrine disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Dental caries | Gastrointestinal disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 2 | 17 | 2 |
| other | Gingival oedema | Gastrointestinal disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 1 |
| other | Vomiting | Gastrointestinal disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 2 | 17 | 3 |
| other | Injection site pain | General disorders | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 | 2 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 0 | 17 |
| Total, other adverse events | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 16 | 17 |
| Total, serious adverse events | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | 1 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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