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Sequential Therapy for Hypogonadotropic Hypogonadism

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ClinicalTrials.gov Identifier: NCT01403532
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 1, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date February 11, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Sperm density ≥1,000,000/ml [ Time Frame: One and a half year ]
The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sequential Therapy for Hypogonadotropic Hypogonadism
Official Title  ICMJE Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypogonadotropic Hypogonadism
  • Kallmann Syndrome
Intervention  ICMJE
  • Drug: Traditional intervention for HH using HCG and FSH
    Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;
    Other Name: Tranditional
  • Drug: Sequential intervention for HH using HCG and FSH
    Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months
    Other Name: Sequential
  • Drug: Sequential intervention for HH using HCG and FSH plus zinc
    Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily
    Other Name: Sequential plus
Study Arms  ICMJE
  • Active Comparator: Traditional
    Intervention: Drug: Traditional intervention for HH using HCG and FSH
  • Experimental: Sequential
    Intervention: Drug: Sequential intervention for HH using HCG and FSH
  • Experimental: Sequential Plus
    Intervention: Drug: Sequential intervention for HH using HCG and FSH plus zinc
Publications * Zhang M, Tong G, Liu Y, Mu Y, Weng J, Xue Y, Luo Z, Xue Y, Shi L, Wu X, Sun S, Zhu Y, Cao Y, Zhang J, Huang H, Niu B, Li H, Guo Q, Gao Y, Li Z, Ning G, Zhu D, Li X; HHIS Study Group. Sequential Versus Continual Purified Urinary FSH/hCG in Men With Idiopathic Hypogonadotropic Hypogonadism. J Clin Endocrinol Metab. 2015 Jun;100(6):2449-55. doi: 10.1210/jc.2014-3802. Epub 2015 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2014)
100
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
90
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403532
Other Study ID Numbers  ICMJE CCEMD005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiao-Ying Li, MD,PhD Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP