Hypogonadotropic Hypogonadism
Conditions
Brief summary
The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to \<18. In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this estimation study
Interventions
DRUGCorifollitropin alfa
CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight \>60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).
DRUGhCG
hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
14 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Have legal representative who understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to the individual's participation by giving written informed consent, and the individual has an age-appropriate understanding of the same to give informed written assent if applicable. * Diagnosed with hypogonadotropic hypogonadism (either isolated or associated with panhypopituitarism), either congenital or acquired with onset prior to puberty. * Have bilateral pre-gonadarche testes as defined by testicular volume \<4.0 mL for each testicle, as determined by ultrasound and assessed by the investigator (if qualified) or local radiologist with appropriate training and expertise in reading testicular ultrasound. Note: participants with a volume of \<4.0 mL in one testicle and a volume of 4-8 mL in the other testicle are considered to be pre-gonadarche and may participate, if there is no history or evidence of a primary testicular disorder (see
Exclusion criteria
1 and 2). * Have circulating levels of total testosterone (Total T) less than the lower limit of normal (LLN) of 8.3 nmol/L as specified by the central lab for a young healthy adult male. * Have follicle stimulating hormone (FSH) ≤2 IU/L and luteinizing hormone (LH) ≤2 IU/L. * Have inhibin-B levels ≤35 pg/mL. (Note: if individual has inhibin-B levels \>35 pg/mL, but meets all of the other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Brazil, Denmark, Italy, Mexico, Russia, South Africa
Participant flow
Pre-assignment details
Male participants with Hypogonadotropic Hypogonadism (HH) aged 14 to \<18 years were enrolled in the study. A total of 17 participants were allocated to the study treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) Participants received 100 μg (if body weight was ≤60 kg) or 150 μg (if body weight was \>60 kg) of CFA as a subcutaneous (SC) injection once every 2 weeks for 64 Weeks (Day 1, Week 0 through Week 64) and 500-5000 IU of hCG reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64). The total treatment duration was 64 Weeks. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) |
|---|---|
| Age, Continuous | 15.5 years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 17 Participants |
| Testicular Volume (TV) | 2.2 mL STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 16 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Change From Baseline in Log-Transformed Testicular Volume (TV) to 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.
Time frame: Baseline and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 | Baseline | 1.5 mL | Standard Deviation 0.7 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 | Week 64 | 14.5 mL | Standard Deviation 6.8 |
95% CI: [7.44, 11.97]
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
Time frame: Up to approximately 64 Weeks
Population: All participants who received at least 1 dose of study treatment were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Number of Participants Who Discontinued Study Treatment Due to an AE | 1 Participants |
Primary
Number of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: Up to approximately 71 Weeks
Population: All participants who received at least 1 dose of study treatment were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Number of Participants Who Experienced an Adverse Event (AE) | 16 Participants |
Primary
Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies
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.
Time frame: Up to approximately 71 Weeks
Population: All participants who received at least 1 dose of study treatment were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies | 0 Percentage of Participants |
Secondary
Change From Baseline in Anti-Müllerian Hormone (AMH) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Anti-Müllerian Hormone (AMH) to Week 12, Week 36, and Week 64 | Baseline | 23.62 ug/L | Standard Deviation 11.07 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Anti-Müllerian Hormone (AMH) to Week 12, Week 36, and Week 64 | Baseline to Week 12 | 17.98 ug/L | Standard Deviation 8.39 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Anti-Müllerian Hormone (AMH) to Week 12, Week 36, and Week 64 | Baseline to Week 36 | -10.23 ug/L | Standard Deviation 15.69 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Anti-Müllerian Hormone (AMH) to Week 12, Week 36, and Week 64 | Baseline to Week 64 | -15.83 ug/L | Standard Deviation 11.58 |
Secondary
Change From Baseline in Calculated Free Testosterone (T) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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 Estradiol (E2) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64 | Baseline | 9.51 ng/L | Standard Deviation 0 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64 | Baseline to Week 12 | 0.81 ng/L | Standard Deviation 2.9 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64 | Baseline to Week 36 | 37.57 ng/L | Standard Deviation 28.73 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64 | Baseline to Week 64 | 45.58 ng/L | Standard Deviation 41.09 |
Secondary
Change From Baseline in Luteinizing Hormone (LH) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64 | Baseline | 0.25 IU/L | Standard Deviation 0.24 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64 | Baseline to Week 12 | -0.08 IU/L | Standard Deviation 0.15 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64 | Baseline to Week 36 | -0.13 IU/L | Standard Deviation 0.25 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64 | Baseline to Week 64 | -0.14 IU/L | Standard Deviation 0.25 |
Secondary
Change From Baseline in Serum Inhibin B Concentration to 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.
Time frame: Baseline and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Serum Inhibin B Concentration to Week 64 | Baseline | 31.92 ng/L | Standard Deviation 35.3 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Serum Inhibin B Concentration to Week 64 | Baseline to Week 64 | 91.46 ng/L | Standard Deviation 59.25 |
Secondary
Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to Week 12, Week 36, and Week 64 | Baseline | 1.53 ug/dL | Standard Deviation 0.91 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to Week 12, Week 36, and Week 64 | Baseline to Week 12 | 0.04 ug/dL | Standard Deviation 0.45 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to Week 12, Week 36, and Week 64 | Baseline to Week 36 | -0.53 ug/dL | Standard Deviation 0.73 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to Week 12, Week 36, and Week 64 | Baseline to Week 64 | -0.68 ug/dL | Standard Deviation 0.76 |
Secondary
Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | Baseline (BL) Tanner I | 6 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II | 6 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner III | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner IV | 0 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner V | 0 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 12 Tanner I | 5 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 12 Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 12 Tanner II | 5 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 12 Tanner III | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner III to Week 12 Tanner III | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner II | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner III | 4 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 36 Tanner II | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 36 Tanner III | 4 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner III to Week 36 Tanner IV | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner III | 3 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner IV | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner V | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 64 Tanner III | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 64 Tanner IV | 3 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 64 Tanner V | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner II to Week 64 Unknown | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64 | BL Tanner III to Week 64 Tanner IV | 1 Participants |
Secondary
Change From Baseline in Testicular Echogenicity to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: Baseline (BL) to Week 12: Hypoechoic | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 12: Isoechoic | 10 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 12: Hyperechoic | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 12: Hypoechoic | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 12: Isoechoic | 12 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 36: Hypoechoic | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 36: Isoechoic | 10 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 36: Hyperechoic | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 36: Hypoechoic | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 36: Isoechoic | 9 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 36: Hyperechoic | 3 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 64: Hypoechoic | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 64: Isoechoic | 8 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Left Testes: BL to Week 64: Hyperechoic | 3 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 64: Isoechoic | 10 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64 | Right Testes: BL to Week 64: Hyperechoic | 3 Participants |
Secondary
Change From Baseline in Total Testosterone (Total T) to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Total Testosterone (Total T) to Week 12, Week 36, and Week 64 | Baseline | 0.11 ug/L | Standard Deviation 0.12 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Total Testosterone (Total T) to Week 12, Week 36, and Week 64 | Baseline to Week 12 | -0.01 ug/L | Standard Deviation 0.07 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Total Testosterone (Total T) to Week 12, Week 36, and Week 64 | Baseline to Week 36 | 4.87 ug/L | Standard Deviation 3.97 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in Total Testosterone (Total T) to Week 12, Week 36, and Week 64 | Baseline to Week 64 | 5.31 ug/L | Standard Deviation 3.31 |
Secondary
Change From Baseline in TS of Pubertal Development for Genital Growth to 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.
Time frame: Baseline, Week 12, Week 36, and Week 64
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | Baseline (BL) Tanner I | 12 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner III | 0 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner IV | 0 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner V | 0 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 12 Tanner I | 9 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 12 Tanner II | 3 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner II to Week 12 Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner I | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner III | 8 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 36 Tanner IV | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner II to Week 36 Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner II | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner III | 4 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner IV | 4 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Tanner V | 2 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner I to Week 64 Unknown | 1 Participants |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64 | BL Tanner II to Week 64 Tanner III | 1 Participants |
Secondary
Growth Velocity at 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.
Time frame: Week 36
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Growth Velocity at Week 36 | 8.3 cm/year | Standard Error 1.1 |
Secondary
Growth Velocity at 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.
Time frame: Week 64
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Growth Velocity at Week 64 | 7.6 cm/year | Standard Error 1 |
Secondary
Mean Serum Concentration of CFA
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.
Time frame: 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
Population: All enrolled participants in the study were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 1 | 0.0 ng/L | Standard Deviation 0 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 1 (6-24 hours) | 4100 ng/L | Standard Deviation 2630 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 3 (32-52 hours) | 5880 ng/L | Standard Deviation 1640 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 5 (72-120 hours) | 4240 ng/L | Standard Deviation 1180 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 8 (144-192 hours) | 2110 ng/L | Standard Deviation 864 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 11 (216-264 hours) | 1150 ng/L | Standard Deviation 655 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 29 | 480 ng/L | Standard Deviation 348 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 85 | 695 ng/L | Standard Deviation 1310 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 169 | 691 ng/L | Standard Deviation 1060 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 253 | 301 ng/L | Standard Deviation 297 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Predose Day 337 | 556 ng/L | Standard Deviation 1260 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 449 | 864 ng/L | Standard Deviation 1290 |
| Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG) | Mean Serum Concentration of CFA | Postdose Day 456 | 0.0 ng/L | Standard Deviation 0 |