Corifollitropin alfa in adolescent males with hypogonadotropic hypogonadism
- Conditions
- Treatment of adolescent males 14 to <18 years old with HHMedDRA version: 20.0Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadismSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2015-001878-18-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 17
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 <18 years of age at the time when consent/assent is signed, with treatment to begin prior to the subject’s 18th birthday.
4. Have been diagnosed with hypogonadotropic hypogonadism (either isolated or associated with panhypopituitarism), either congenital or acquired with onset prior to puberty.
Note: Subjects with drug-induced hypogonadotropic hypogonadism (e.g., misuse of anabolic steroids, chronic use of glucocorticoids or narcotic analgesics, etc.) are excluded.
5. Have bilateral pre-gonadarche testes as defined by testicular volume <4.0 mL for each testicle, as determined by ultrasound and assessed by central imaging vendor. Note: subjects 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).
6. Have circulating levels of 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.
7. Have FSH < or = 2 IU/L and LH < or = 2 IU/L.
8. Have inhibin-B levels < or = 35 pg/mL.
Note: if the subject 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. The subject may be enrolled if either of the following is met:
-GnRH agonist (GnRHa) stimulation test: LH level of <3 IU/L at all of the following timepoints: 0, 60, 120, and 180 minutes after subcutaneous administration of a GnRH agonist, e.g., 500 micrograms of leuprolide acetate.
-GnRH IV infusion test: LH peak <5.8 IU/L and FSH peak <4.6 IU/L at all of the following timepoints: 0, 15, 30, 45, 60 and 120 minutes during intravenous infusion of GnRH 100 micrograms over 120 minutes.
9. Be in good general physical and mental health, in the opinion of the investigator/sponsor, as assessed by physical examination and routine clinical laboratory tests.
10. Have a parent/guardian able and willing to support the subject’s participation by supporting adherence to study drug dosing and visit schedules.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method