Sequential Therapy for Hypogonadotropic Hypogonadism
Information source: Shanghai Jiao Tong University School of Medicine
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadotropic Hypogonadism; Kallmann Syndrome
Intervention: Tranditional 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 (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s):
Xiao-Ying Li, MD,PhD, Principal Investigator, Affiliation: Shanghai Jiao Tong University School of Medicine
Overall contact:
Manna Zhang, MD, Phone: 86-21-64370045, Ext: 610915, Email: mannazhang@126.com
Summary
The traditional therapy for induction of spermotogenesis 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.
Clinical Details
Official title: Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sperm density ≥1,000,000/ml
Eligibility
Minimum age: 16 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Manna Zhang, MD, Phone: 86-21-64370045, Ext: 610915, Email: mannazhang@126.com
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025, China; Recruiting
Manna Zhang, MD, Phone: 86-021-64370045, Ext: 610915, Email: mannazhang@126.com
Additional Information
Starting date: September 2009
Last updated: July 26, 2011
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