Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310074
Recruitment Status : Unknown
Verified December 2014 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2014
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date February 3, 2015
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
pregnancy in the female partner [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02310074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • first appearance of sperm (month after treatment) [ Time Frame: 18 months ]
  • first time with sperm density>1*10^6/ml(month after treatment) [ Time Frame: 18 months ]
  • first time with sperm density>15*10^6/ml(month after treatment) [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2015)
  • testicular volume [ Time Frame: 18 months ]
  • prostatic volume [ Time Frame: 18 months ]
  • Tanner stage for pubic hair [ Time Frame: 18 months ]
  • Tanner stage for genital [ Time Frame: 18 months ]
  • serum hormone levels [ Time Frame: 18 months ]
    especially serum testosterone, LH, and FSH levels
  • sperm concentration per ejaculate [ Time Frame: 18 months ]
  • adverse events [ Time Frame: 18 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
Official Title  ICMJE Study on the Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism
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 gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.
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 gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.

The primary endpoint was the achievement of pregnancy in female partner. Secondary endpoints were time to actual attainment of various sperm thresholds: sperm concentration>0*10^6/ml , >1.0 *10^6/ml and >15 *10^6/ml, respectively.

The clinical and laboratory characteristics including testicular and prostatic volume, Tanner stage for pubic hair and genital, serum hormone levels [especially serum testosterone,luteinizing hormone (LH) , and Follicle-Stimulating Hormone (FSH) levels], sperm concentration per ejaculate, and adverse events at baseline and at the end of treatment were also evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Hypogonadotropic Hypogonadism
Intervention  ICMJE
  • Drug: Pulsatile Gonadotropin Releasing Hormone
    Other Name: Pulsatile GnRH pump
  • Drug: Human chorionic gonadotropin
    Human chorionic gonadotropin (hCG)
  • Drug: Urinary Follicle-Stimulating Hormone
    Urinary Follicle-Stimulating Hormone (uFSH)
Study Arms  ICMJE
  • Experimental: Pulsatile Gonadotropin Releasing Hormone
    Pulsatile Gonadotropin Releasing Hormone: subjects in the GnRH group initiated a regimen of pulsatile GnRH administered subcutaneously via a portable infusion pump for 18 months.
    Intervention: Drug: Pulsatile Gonadotropin Releasing Hormone
  • Active Comparator: combination gonadotropin therapy
    combined human chorionic gonadotropin (hCG)/urinary Follicle-Stimulating Hormone (uFSH) therapy:HCG treatment was maintained alone for 6 months and then uFSH was added for the next 12 months
    Interventions:
    • Drug: Human chorionic gonadotropin
    • Drug: Urinary Follicle-Stimulating Hormone
Publications * Not Provided

*   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 Unknown status
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
76
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. With any significant medical condition (including malignant disease), laboratory abnormality, or psychiatric disorders that will prevent the subject from participating in the study
  2. Congenital hypopituitarism
  3. Any medical or surgical conditions possibly affecting the experiment result
  4. Any clinically significant allergic diseases or allergic to the study drugs
  5. Recently drug or alcohol abuse(>35unit/week,1unit=8 g alcohol@1 standard drink@250ml beer@140ml wine@25ml strong alcohol drink like whiskey.)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years to 35 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02310074
Other Study ID Numbers  ICMJE ruijin-GnRH pump-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guang Ning, 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: Guang Ning, MD, PHD Shanghai Jiao Tong University School of Medicine
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date December 2014

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