Status:

UNKNOWN

Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

Lead Sponsor:

Shanghai Jiao Tong University School of Medicine

Conditions:

Idiopathic Hypogonadotropic Hypogonadism

Eligibility:

MALE

16-35 years

Phase:

PHASE4

Brief Summary

Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of g...

Detailed Description

Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of g...

Eligibility Criteria

Inclusion

  • Age greater than 16 yr
  • Diagnosed as idiopathic hypogonadotropic hypogonadism with clinical signs or symptoms of hypogonadism
  • Hypogonadal serum testosterone levels (\<166ng/dl) in the presence of low or normal gonadotropins
  • Normal levels of other anterior pituitary hormones
  • Normal MRI scans of the hypothalamo-pituitary region
  • Had discontinued any prior treatment (testosterone or gonadotropin therapy) for at least three months before enrollment

Exclusion

  • With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study
  • Congenital hypopituitarism
  • Any medical or surgical conditions possibly affecting the experiment result
  • Any clinically significant allergic diseases or allergic to the study drugs
  • Recently drug or alcohol abuse(\>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT02310074

Start Date

January 1 2010

Last Update

February 3 2015

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