Hypogonadotropic HypogonadismPhase 3NCT03019575
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)
A Phase 3 study testing Corifollitropin alfa and hCG in people with Hypogonadotropic Hypogonadism, run by Organon and Co at 15 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men only
- Conditions the study is for
- Hypogonadotropic Hypogonadism
- What is being tested?
- Corifollitropin alfa and hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 2 Feb 2017to 5 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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/exclusion criteria, either a GnRH agonist (GnRHa) stimulation test or GnRH IV infusion test may be performed.
- In good general physical and mental health, in the opinion of the investigator/sponsor, as assessed by physical examination and routine clinical laboratory tests.
- Have a parent/guardian able and willing to support the individual's participation by supporting adherence to study drug dosing and visit schedules.
Who cannot join
- Have a history of bilateral cryptorchidism (maldescended testes) or unilateral cryptorchidism treated after the age of 2 years.
- Have a history or presence of clinically significant testicular problems (e.g., epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy, occlusive azoospermia, etc.) that would impair participants response to treatment or has had known damage or injury to the vas deferens.
- Had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens (e.g., testosterone, etc.). Note: Use of GnRH and gonadotropins for diagnostic testing purposes only is allowed. Participants with use of hCG and androgen therapy prior to the age of 2 years old can be included in the trial. Participants with transient use of androgens (i.e., for less than 2 weeks) that was stopped at least 6 months prior to signing informed consent can also be included in the trial.
- Has an untreated or inadequately treated pituitary or hypothalamic tumor.
- Have uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary disorders not on stable replacement therapies.
- Has a history of active pituitary hypersecretion as evidenced by hyperprolactinemia or Cushing's disease, acromegaly, or any other active pituitary hypersecretion syndrome. (Note: Individuals who have been treated and are clinically stable, with no evidence of hypersecretion for at least 12 months prior to screening, may participate.
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- Has had hypophysectomy within 12 months to the start of screening.
- Has history of oncologic chemotherapy treatment.
- Has had brain radiotherapy within 12 months of start of treatment for a primary tumor, or any history of brain radiotherapy for metastatic disease.
- Has diabetes mellitus.
- Has history of Human Immunodeficiency Virus (HIV).
- Has renal insufficiency, as determined by investigator, based on serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate.
- Has clinically significant liver disease, including active viral hepatitis or cirrhosis. Individuals with a prior history of liver disease which is now inactive or successfully treated may be enrolled if all liver function values performed within the past year have been normal and within the normal range at Visit 1.
- Has had a recent history of recreational or illicit drug use, including marijuana; or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
- Has an allergy/sensitivity to gonadotropins or its/their excipients.
- Has used an investigational drug and/or participated in any other clinical trial within the past 8 weeks (prior to Visit 2), or will participate in any other clinical trials (excluding surveys) during the course of this trial.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Russia5 sites
Kazan State Medical University ( Site 0024)
Kazan', 420048
Federal State Budget Institution Endocrinological Research Center ( Site 0021)
Moscow, 117036
City children polyclinic #44 ( Site 0025)
Saint Petersburg, 191144
St.Petersburg State Pediatric Medical University ( Site 0023)
Saint Petersburg, 194100
Republic Children Clinical Hospital ( Site 0022)
Ufa, 450106
Brazil3 sites
Centro de Diabetes Curitiba ( Site 0012)
Curitiba, 80810-040
Hospital de Clinicas de Porto Alegre ( Site 0014)
Porto Alegre, 90035-903
Hosp das Clinicas da Faculdade de Medicina da Univ de Sao Paulo ( Site 0015)
São Paulo, 05403-000
Italy3 sites
AOU Careggi ( Site 0042)
Florence, 50139
Policlinico Umberto I ( Site 0043)
Roma, 00161
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0044)
Roma, 00165
Mexico2 sites
Instituto Nacional de Pediatria ( Site 0007)
Mexico City, 04530
Hospital Infantil de Mexico Federico Gomez ( Site 0006)
Mexico City, 06720
Denmark1 site
Rigshospitalet, University department of Growth and Reproduction ( Site 0051)
Copenhagen, 2100
South Africa1 site
Little Company of Mary Hospital ( Site 0017)
Pretoria, 0181
About this study
Official title: A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)
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
- Conditions
- Hypogonadotropic Hypogonadism
- Being tested
- Corifollitropin alfa, hCG
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifollitropin alfaDrug
Also called MK-8962, Elonva
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).
hCGDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Corifollitropin alfa (CFA)+human Chorionic Gonadotropin (hCG) | Experimental | 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. Receives: Drug: Corifollitropin alfa; Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 64
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.
Measured: Up to approximately 71 Weeks
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.
Measured: Up to approximately 64 Weeks
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.
Measured: Up to approximately 71 Weeks
Secondary outcomes (13)
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.
Measured: Baseline and Week 64
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.
Measured: Week 36
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.
Measured: Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: 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
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
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.
Measured: Baseline, Week 12, Week 36, and Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start2 Feb 2017
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019575
- Sponsor's protocol ID
- 8962-043
- Other IDs
- 2015-001878-18, MK-8962-043, 2015
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2017
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)
- ClinicalTrials.gov ID
- NCT03019575
- Acronym / sponsor ID
- 8962-043
- Conditions
- Hypogonadotropic Hypogonadism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corifollitropin alfa (CFA)+human Chorionic Gonadotropin (hCG) | Experimental | Drug: Corifollitropin alfa, Drug: hCGParticipants 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- Have a history of bilateral cryptorchidism (maldescended testes) or unilateral cryptorchidism treated after the age of 2 years.
- Have a history or presence of clinically significant testicular problems (e.g., epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy, occlusive azoospermia, etc.) that would impair participants response to treatment or has had known damage or injury to the vas deferens.
- Had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens (e.g., testosterone, etc.). Note: Use of GnRH and gonadotropins for diagnostic testing purposes only is allowed. Participants with use of hCG and androgen therapy prior to the age of 2 years old can be included in the trial. Participants with transient use of androgens (i.e., for less than 2 weeks) that was stopped at least 6 months prior to signing informed consent can also be included in the trial.
- Has an untreated or inadequately treated pituitary or hypothalamic tumor.
- Have uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary disorders not on stable replacement therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corifollitropin alfaAlso: MK-8962, ElonvaCFA 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). | Drug | Corifollitropin alfa (CFA)+human Chorionic Gonadotropin (hCG) |
| hCGhCG 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). | Drug | Corifollitropin alfa (CFA)+human Chorionic Gonadotropin (hCG) |
Primary outcome
Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
13 secondary outcomes
Change From Baseline in Serum Inhibin B Concentration to Week 64
Time frame: Baseline and Week 64
Growth Velocity at Week 36
Time frame: Week 36
Growth Velocity at Week 64
Time frame: Week 64
Change From Baseline in Tanner Stage (TS) of Pubertal Development for Pubic Hair to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in TS of Pubertal Development for Genital Growth to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
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
Change From Baseline in Testicular Echogenicity to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Luteinizing Hormone (LH) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Calculated Free Testosterone (T) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Total Testosterone (Total T) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Estradiol (E2) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Sex Hormone-Binding Globulin (SHBG) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Change From Baseline in Anti-Müllerian Hormone (AMH) to Week 12, Week 36, and Week 64
Time frame: Baseline, Week 12, Week 36, and Week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corifollitropin alfa and hCG in people with Hypogonadotropic Hypogonadism, run by Organon and Co at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia, Brazil, Italy, Mexico, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Log-Transformed Testicular Volume (TV) to Week 64 (time frame: Baseline and Week 64). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.