Trial · NCT03019575
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | Testicular Echogenicity was determined by evaluating the sonographic patterns obtained on testicular ultrasound of right and left testes at baseline, Week 12, Week 36 and 64. The sonographic patterns were assessed by central imaging unit by an independent radiologist and categorized as Hypoechoic (decreased echogenicity as compared to echogenicity at baseline), Isoechoic (same echogenicity as compared to echogenicity at baseline) and Hyperechoic (increased echogenicity as compared to echogenicity at baseline). The number of participants with a sonographic pattern at Weeks 12, 36 and 64 were reported. |
| Secondary | Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | LH is a gonadotropin secreted from the anterior pituitary and is a marker for spontaneous puberty. Blood samples were collected at baseline, Week 12, Week 36 and Week 64 to report the mean change from baseline in LH level to Weeks 12, 36 and 64. |
| 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 | Blood samples were collected at baseline, Week 12, Week 36 and Week 64 to report the mean change from baseline in T level to Weeks 12, 36 and 64. The change from baseline in T level to Week 12, 36, and 64 could not be calculated as planned because only 2 participants had baseline T level values which were insufficient to provide the trend change from baseline in T level to Week 12, 36, and 64. |
| 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 | Total T is a marker for progress of puberty in males. Total T levels increase during puberty as the testes respond to the gonadotropins. Blood samples were collected at baseline, Week 12, Week 36 and Week 64 post dose to report the mean change from baseline in Total T level to Weeks 12, 36 and 64. A negative value indicated a lower Total T level. |
| Secondary | Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64 | Baseline, Week 12, Week 36, and Week 64 | E2 levels rise during puberty in males when some of the T secreted is aromatized. Blood samples were collected at baseline, Week 12, Week 36 and Week 64 to report the mean change from baseline in E2 level to Weeks 12, 36 and 64. A positive value indicated a higher E2 level. |
| 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 | SHBG is a blood protein that controls the amount of T body tissues in males. SHBG is regulated by the ratio of T and E2 levels in addition to other factors (thyroid hormone status, dietary factors, certain diseases and medications). Blood samples were collected at baseline, Week 12, Week 36 and Week 64 to report the mean change from baseline in SHBG level to Weeks 12, 36 and 64. A negative value indicated a lower SHBG level. |
| 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 | AMH is a marker for progress of puberty in males. Blood samples were collected at baseline, Week 12, Week 36 and Week 64 to report the mean change from baseline in AMH level to Weeks 12, 36 and 64. A negative value indicated a lower AMH level. |
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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