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Sequential Therapy for Hypogonadotropic Hypogonadism

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xiao-Ying Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01403532
First received: February 1, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypogonadotropic Hypogonadism
Kallmann Syndrome
 Drug: 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
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Human Chorionic Gonadotropin (HCG) and Follicle Stimulating Hormone (FSH) in the Treatment of Hypogonadotropic Hypogonadism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Sperm density ≥1,000,000/ml [ Time Frame: One and a half year ] [ Designated as safety issue: Yes ]
    The sperm will be counted as equal or more than 1,000,000/ml under microscope for each subject.


Estimated Enrollment: 90
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Drug: Tranditional intervention for HH using HCG and FSH
Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half; Follicle stimulating hormone,75U, im, 3 times/week, one year;
Other Name: Tranditional
Experimental: Sequential 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
Experimental: Sequential Plus 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

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403532

Locations
China, Shanghai
Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xiao-Ying Li, MD,PhD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Xiao-Ying Li, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01403532     History of Changes
Other Study ID Numbers: CCEMD005
Study First Received: February 1, 2011
Last Updated: June 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Hypogonadotropic Hypogonadism
Kallmann Syndrome
LH
FSH

Additional relevant MeSH terms:
Hypogonadism
Kallmann Syndrome
Gonadal Disorders
Endocrine System Diseases
46, XY Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
 Chorionic Gonadotropin
Follicle Stimulating Hormone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013