Trial Outcomes & Findings for 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 NCT03019575)
NCT ID: NCT03019575
Last Updated: 2024-05-23
Results Overview
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.
COMPLETED
PHASE3
17 participants
Baseline and Week 64
2024-05-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 Participants
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.
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|---|---|
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Age, Continuous
|
15.5 years
STANDARD_DEVIATION 0.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Testicular Volume (TV)
|
2.2 mL
STANDARD_DEVIATION 1.9 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
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|---|---|
|
Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64
Baseline
|
1.5 mL
Standard Deviation 0.7
|
|
Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64
Week 64
|
14.5 mL
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Up to approximately 71 WeeksPopulation: All participants who received at least 1 dose of study treatment were analyzed.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 Participants
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.
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|---|---|
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Number of Participants Who Experienced an Adverse Event (AE)
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16 Participants
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PRIMARY outcome
Timeframe: Up to approximately 64 WeeksPopulation: All participants who received at least 1 dose of study treatment were analyzed.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 Participants
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.
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|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 71 WeeksPopulation: All participants who received at least 1 dose of study treatment were analyzed.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 Participants
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.
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|---|---|
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Percentage of Participants With Anti-Corifollitropin Alfa (CFA) Antibodies
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
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|---|---|
|
Change From Baseline in Serum Inhibin B Concentration to Week 64
Baseline
|
31.92 ng/L
Standard Deviation 35.30 • Interval 35.3 to
|
|
Change From Baseline in Serum Inhibin B Concentration to Week 64
Baseline to Week 64
|
91.46 ng/L
Standard Deviation 59.25 • Interval 59.25 to
|
SECONDARY outcome
Timeframe: Week 36Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
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|---|---|
|
Growth Velocity at Week 36
|
8.3 cm/year
Standard Error 1.1 • Interval 1.1 to
|
SECONDARY outcome
Timeframe: Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=12 Participants
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.
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|---|---|
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Growth Velocity at Week 64
|
7.6 cm/year
Standard Error 1.0 • Interval 1.0 to
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
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|---|---|
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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
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|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
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|---|---|
|
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
|
|
Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64
BL Tanner II
|
1 Participants
|
|
Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64
BL Tanner III
|
0 Participants
|
|
Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64
BL Tanner IV
|
0 Participants
|
|
Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64
BL Tanner V
|
0 Participants
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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: postdosePopulation: All enrolled participants in the study were analyzed.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 Participants
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.
|
|---|---|
|
Mean Serum Concentration of CFA
Predose Day 1
|
0.0 ng/L
Standard Deviation 0.0
|
|
Mean Serum Concentration of CFA
Postdose Day 1 (6-24 hours)
|
4100 ng/L
Standard Deviation 2630
|
|
Mean Serum Concentration of CFA
Postdose Day 3 (32-52 hours)
|
5880 ng/L
Standard Deviation 1640
|
|
Mean Serum Concentration of CFA
Postdose Day 5 (72-120 hours)
|
4240 ng/L
Standard Deviation 1180
|
|
Mean Serum Concentration of CFA
Postdose Day 8 (144-192 hours)
|
2110 ng/L
Standard Deviation 864
|
|
Mean Serum Concentration of CFA
Postdose Day 11 (216-264 hours)
|
1150 ng/L
Standard Deviation 655
|
|
Mean Serum Concentration of CFA
Predose Day 29
|
480 ng/L
Standard Deviation 348
|
|
Mean Serum Concentration of CFA
Predose Day 85
|
695 ng/L
Standard Deviation 1310
|
|
Mean Serum Concentration of CFA
Predose Day 169
|
691 ng/L
Standard Deviation 1060
|
|
Mean Serum Concentration of CFA
Predose Day 253
|
301 ng/L
Standard Deviation 297
|
|
Mean Serum Concentration of CFA
Predose Day 337
|
556 ng/L
Standard Deviation 1260
|
|
Mean Serum Concentration of CFA
Postdose Day 449
|
864 ng/L
Standard Deviation 1290
|
|
Mean Serum Concentration of CFA
Postdose Day 456
|
0.0 ng/L
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: Baseline (BL) to Week 12: Hypoechoic
|
2 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 12: Isoechoic
|
10 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 12: Hyperechoic
|
1 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 12: Hypoechoic
|
1 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 12: Isoechoic
|
12 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 36: Hypoechoic
|
2 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 36: Isoechoic
|
10 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 36: Hyperechoic
|
1 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 36: Hypoechoic
|
1 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 36: Isoechoic
|
9 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 36: Hyperechoic
|
3 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 64: Hypoechoic
|
2 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 64: Isoechoic
|
8 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Left Testes: BL to Week 64: Hyperechoic
|
3 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 64: Isoechoic
|
10 Participants
|
|
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Right Testes: BL to Week 64: Hyperechoic
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64
Baseline
|
0.25 IU/L
Standard Deviation 0.24
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64
Baseline
|
9.51 ng/L
Standard Deviation 0.00 • Interval 0.0 to
|
|
Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64
Baseline to Week 12
|
0.81 ng/L
Standard Deviation 2.90 • Interval 2.9 to
|
|
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 • Interval 28.73 to
|
|
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 • Interval 41.09 to
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 12, Week 36, and Week 64Population: 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.
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.
Outcome measures
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=13 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
Serious adverse events
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Craniopharyngioma
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
Other adverse events
| Measure |
Corifollitropin Alfa (CFA)+Human Chorionic Gonadotropin (hCG)
n=17 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Endocrine disorders
Hypothyroidism
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Gastrointestinal disorders
Dental caries
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Gastrointestinal disorders
Gingival oedema
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 3 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
General disorders
Injection site pain
|
5.9%
1/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
General disorders
Peripheral swelling
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Respiratory tract infection viral
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Rhinitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Tinea infection
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Tracheitis
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Blood prolactin increased
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Blood testosterone decreased
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Blood testosterone free increased
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Blood testosterone increased
|
23.5%
4/17 • Number of events 4 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Human chorionic gonadotropin increased
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Oestradiol increased
|
29.4%
5/17 • Number of events 5 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Testicular scan abnormal
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Investigations
Ultrasound testes abnormal
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Metabolism and nutrition disorders
Hyperphagia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Nervous system disorders
Cerebrovascular disorder
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 4 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Nervous system disorders
Presyncope
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Reproductive system and breast disorders
Pruritus genital
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Reproductive system and breast disorders
Scrotal disorder
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Reproductive system and breast disorders
Spermatocele
|
29.4%
5/17 • Number of events 6 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Reproductive system and breast disorders
Varicocele
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.8%
2/17 • Number of events 2 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acanthosis nigricans
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
|
|
Vascular disorders
Hot flush
|
5.9%
1/17 • Number of events 1 • All-cause mortality, serious and non-serious AEs were collected for up to approximately 71 Weeks
All participants who received at least one dose of study treatment were analyzed.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER