Trial · NCT03019575
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Testicular Echogenicity 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 Luteinizing Hormone (LH) 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, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline LH values at Weeks 12, 36 and 64 were analyzed. | IU/L | MEAN |
| SECONDARY | Change From Baseline in Calculated Free Testosterone (T) 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 + hCG treatment, had last TV value within 4 weeks from last CFA dose and had a baseline and post baseline T value at Week 12, 36 and 64 were to be analyzed. | ||
| SECONDARY | Change From Baseline in Total Testosterone (Total T) 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, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline Total T value at Week 12, 36 and 64 were analyzed. | ug/L | MEAN |
| SECONDARY | Change From Baseline in Estradiol (E2) 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, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline E2 value at Week 12, 36 and 64 were analyzed. | ng/L | MEAN |
| SECONDARY | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) 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, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline SHBG value at Week 12, 36 and 64 were analyzed. | ug/dL | MEAN |
| SECONDARY | Change From Baseline in Anti-Müllerian Hormone (AMH) 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, had last TV value within 4 weeks from last dose of CFA and had a baseline and post baseline AMH value at Week 12, 36 and 64 were analyzed. | ug/L | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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