Corifollitropin alfa trial in adult men with hypogonadotropic hypogonadism (HH)

Phase 1

• Conditions: Adult men with hypogonadotropic hypogonadism; MedDRA version: 15.0Level: LLTClassification code 10021012Term: Hypogonadotrophic hypogonadismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2012-001258-25-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

-Each subject must have been diagnosed with HH, either congenital or acquired. Note: Subjects with drug-induced HH (e.g. misuse of anabolic steroids, chronic use of glucocorticoids or narcotic analgesics, etc.) are not allowed to participate.
-Each subject must be ?18 to ?50 years of age at the time of signing ICF.
-Each subject must have low circulating levels of Testosterone (T): T ? 6 nmol/L, as assessed after an adequate wash-out period from previous testosterone use (if applicable).
-Each subject must have low circulating levels of gonadotropins: follicle stimulating hormone (FSH) ? 2 IU/L and luteinizing hormone (LH) ? 2 IU/L (after adequate wash-out from previous testosterone use [if applicable]).
- Each subject must have presence of scrotal testes (left and right).
- Each subject must have azoospermia (according to the World Health Organization [WHO] criteria).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-The subject has primary hypogonadism, such as Klinefelter's syndrome.
-The subject has a history of unilateral or bilateral cryptorchidism (maldescended testes). Note:
Subjects with a history of unilateral cryptorchidism which was treated before the age of 2 years are allowed in this trial.
- The subject has a history or presence of testicular pathology of clinical importance (e.g., epididymitis,
orchitis, testicular torsion, varicocele stage III, testicular atrophy, occlusive azoospermia, etc), and/or vasectomy.
- The subject has been treated with FSH, hCG or gonadotropin releasing hormone (GnRH) within a period of three months prior to signing informed consent or for more than one month within a period of six months prior to signing informed consent.
-The subject has proven spermatogenesis upon hCG treatment alone.
- The subject has had a previous unsuccessful attempt with hCG in combination with human menopausal gonadotropin (hMG)/FSH to achieve spermatogenesis.
- The subject had required a dose of hCG of more than 6000 IU per week in a previous attempt to normalize T levels.
- The subject has untreated pituitary or hypothalamic tumor, or inadequately treated pituitary or hypothalamic tumor that is likely to progress during the trial.
- The subject has had hypophysectomy within a period of 6 months prior to the start of screening.
At Visit 6 / Day 1
Key Inclusion Criteria:
- Each subject must have circulating T levels within the normal range
- Each subject must still have azoospermia (according to WHO criteria).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified