Sequential Therapy for Hypogonadotropic Hypogonadism

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism

Treatments: Drug: Traditional intervention for HH using HCG and FSH; Drug: Sequential intervention for HH using HCG and FSH; Drug: Sequential intervention for HH using HCG and FSH plus zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT01403532

CCEMD005

Details and patient eligibility

About

The traditional therapy for induction of spermatogenesis in male hypogonadotropic hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the investigators raise a new sequential therapeutic approach which can make the treatment more economic and tolerable. The zinc supplement will be also evaluated in patients in this study. This randomized, parallel, open, and multi-center study will compare the efficacy of traditional therapy with new therapy and evaluate the safety of the new protocol.

Enrollment: 100 patients

Sex: Male

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical hypogonadotropic hypogonadism
• Hormonal levels: Testosterone < 1.8ng/ml, LH < 2-3 mIU/mL and FSH < 2-3 mIU/mL
• Infantile testis
• Delayed bone age
• Normal testing of the anterior pituitary gland

Exclusion criteria

• Prior therapy with HMG or FSH
• Severe dysfunction of live and kidney
• Cryptorchidism or no response to HCG stimulation experiment (Testosterone < 1.8ng/ml after HCG stimulation)
• Another pituitary hormonal deficiency
• Hypergonadotropic hypogonadism
• With abnormal karyotype

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Traditional

Active Comparator group

Treatment:

Drug: Traditional intervention for HH using HCG and FSH

Sequential

Experimental group

Treatment:

Drug: Sequential intervention for HH using HCG and FSH

Sequential Plus

Experimental group

Treatment:

Drug: Sequential intervention for HH using HCG and FSH plus zinc