Treatment of adolescent males 14 to <18 years old with HH MedDRA version: 20.0 Level: LLT Classification code 10021012 Term: Hypogonadotrophic hypogonadism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: ELONVA
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number: 195962-23-3
Concentration unit: µg/ml microgram(s)/millilitre
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Have a legal representative who understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to the subject’s participation by giving written informed consent, and the subject has an age-appropriate understanding of the same to give informed written assent if applicable (i.e., in accordance with local requirements). Subjects with an illiterate legal representative may be included if, in the opinion of the investigator, the legal representative fully understands the risks of the subject’s participation and provides consent. In addition, the legal representative may also consent to (and in accordance with local requirements, the subject may assent to) have the subject participate in Future Biomedical Research by signing a separate consent. Note: otherwise eligible patients will be able to participate in the main study even if they opt to not participate in FBR. 2. Be male. 3. Be 14 to 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. The subject may be enrolled if either of the following is met: -GnRH agonist (GnRHa) stimulation test: LH level of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has a history of bilateral cryptorchidism (maldescended testes) or unilateral cryptorchidism treated after the age of 2 years. 2. Has a history or presence of clinically significant testicular problems (e.g., epididymitis, orchitis, testicular torsion, varicocele Grade III, testicular atrophy, occlusive azoospermia, etc.) that in the opinion of the investigator would impair the subjects response to treatment or has had known damage or injury to the vas deferens. 3. Has had any previous treatment with GnRH, gonadotropins (e.g., hCG, FSH) or androgens (e.g., testosterone, etc.). Note: Use of these agents for diagnostic testing purposes only is allowed. Subjects with transient use of androgen (i.e., for less than 2 weeks) that was stopped at least 6 months prior to signing informed consent can be included in the trial. 4. Has an untreated or inadequately treated pituitary or hypothalamic tumor. 5. Has uncontrolled endocrinopathies, including thyroid, adrenal, and pituitary disorders not on stable replacement therapies (i.e., subject has not been on stable doses for at least 3 months). Note: The subject with a free T4 level outside of the normal laboratory range at the time of screening will be excluded, but may be rescreened once he has been on a stable dose of replacement therapies for at least 3 months. 6. Has a history of active pituitary hypersecretion as evidenced by hyperprolactinemia or Cushing’s disease, or acromegaly, or any other active pituitary hypersecretion syndrome. Note: Subjects who have been treated and are clinically stable, with no evidence of hypersecretion for at least 12 months prior to screening, may participate. 7. Has had hypophysectomy within a period of 12 months prior to the start of screening. 8. Has history of oncologic chemotherapy treatment. 9. Has had brain radiotherapy within 12 months of the start of treatment for a primary tumor, or any history of brain radiotherapy for metastatic disease. 10. Has diabetes mellitus. 11. Has a history of Human Immunodeficiency Virus (HIV). 12. Has clinically significant liver disease, including active viral hepatitis or cirrhosis. Subjects with a prior history of liver disease which is now inactive or successfully treated may be enrolled if all liver function values (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin) performed within the past year have been normal and are within the normal range (per central lab) at V1. Liver function testing may be repeated once prior to allocation of treatment at the discretion of the investigator if results are inconsistent with the subject’s clinical status or recent laboratory results. 13. Has had a recent history (i.e., within 1 year prior to signing the informed consent) of recreational (e.g., for non-medical purposes) 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. Note: (1) Alcohol abuse is defined as routinely consumes >2 alcoholic drinks per day. One alcoholic drink is defined as 5 oz (150 mL) of wine, or 12 oz (350 mL) of beer, or 1.5 oz (50 mL) of 80-proof liquor. Note: (2) Binge drinking is defined as a pattern of 5 or more alcoholic drinks (male), or 4 or more alcoholic drinks (female) in about 2 hours. 14. Has received any treatment listed in Table “Prohibited Medications” more recently than the indicated wash-out period prior to Screening. 15. Has an allergy/sensitivity to gonado
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change from baseline in serum inhibin B concentrations 2.Growth velocity 3.Tanner Stage of pubertal development 4.Characterization of MK-8962 pharmacokinetics (based on serum MK-8962 concentrations) 5.Characterization of testicular sonographic pattern reflecting pubertal development 6.Changes from baseline in endocrine parameters ;Timepoint(s) of evaluation of this end point: 1.Week 64 2.Week 36 and Week 64 3.Weeks 12, 36 and 64. 4.Through 64 weeks of treatment. 5.Through 64 weeks of treatment 6.Weeks 12, 36 and 64 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Objective: To estimate the change from baseline in testicular volume (measured as the sum of volumes of left and right testes by ultrasound) after 64 weeks of treatment with MK-8962 (in combination with hCG for the last 52 weeks). 2) Objective: To evaluate the safety and tolerability of MK-8962 over 64 weeks of treatment, including evaluation of development of antibodies to MK-8962.;Secondary Objective: To evaluate the following parameters over 64 weeks of treatment with MK-8962 (in combination with hCG for the last 52 weeks): 1) Objective: the change from baseline in inhibin B concentrations. 2) Objective: growth velocity (height). 3) Objective: the change from baseline in Tanner Stage of pubertal development. 4) Objective: the change from baseline in levels of endocrine parameters (i.e., luteinizing hormone [LH], calculated free testosterone [T], total testosterone [Total T], estradiol [E2], sex hormone-binding globulin [SHBG], and anti-Müllerian hormone [AMH]. 5) Objective: testicular sonographic pattern reflecting pubertal development. 6) Objective: the PK of MK-8962 (based on serum MK-8962 concentrations).;Primary end point(s): The primary efficacy endpoint for this trial is the change from Baseline (Day 1) to Week 64 in log-transformed testicular volume (measured as the sum of volumes of left and right testes by ultrasound).;Timepoint(s) of evaluation of this end point: Visit 1, 2, 9, 12, 15 or post-treatment follow up visit and discontinuation or post-treatment follow up visit | — |
Countries
Brazil, Denmark, Italy, Mexico, Russian Federation, South Africa, United States
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia Srl
Outcome results
None listed