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Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome

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ClinicalTrials.gov Identifier: NCT02705014
Recruitment Status : Unknown
Verified March 2016 by wuxueyan, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
wuxueyan, Peking Union Medical College Hospital

Brief Summary:
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy.

Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Drug: Gonadotropin-releasing Hormone Not Applicable

Detailed Description:
To investigate the hormone response of hypothalamic-pituitary-gonad axis and spermatogenesis in male pituitary stalk interruption syndrome patients by pulsatile GnRH therapy. The hormonal response of the hypothalamic-pituitary-gonad axis was assessed after pulsatile GnRH replacement by measurement of serum T, LH and FSH. A standard seminal fluid analysis was performed in men who could produce an ejaculate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: treatment group
patients were administered with pulsatile gonadotropin-releasing hormone (GnRH )therapy for 12 months at an interval of 90 minutes.The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L.
Drug: Gonadotropin-releasing Hormone
A regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL).
Other Name: Gonadorelin




Primary Outcome Measures :
  1. Change of serum Luteinizing Hormone(LH) value [ Time Frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment. ]
    Luteinizing hormone (LH) is measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.24-8.62 IU/L. Initial efficacy is evaluated based on the values of serum LH and serum total testosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.

  2. Change of serum Follicle-Stimulating Hormone (FSH) value [ Time Frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment. ]
    Follicle-stimulating hormone (FSH) are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 1.27-19.26 IU/L.

  3. Change of serum total testosterone value [ Time Frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment. ]
    Total testosterone levels are measured using commercial kits by chemiluminescent method (ACS 180 Automatic Chemiluminescence System; Bayer). Reference range: 175-781 ng/dL.Initial efficacy is evaluated based on the values of serum LH and serum totaltestosterone. If a subject's serum LH value below 1.5 IU/L and serum total testosterone value below 100 ng/dL at 3m post treatment, it is defined as failure to pulsatile GnRH treatment and continuous treatment is stopped. Otherwise, pulsatile GnRH treatment is continued.


Secondary Outcome Measures :
  1. Change of testicular volume [ Time Frame: Baseline and at 1m,3m, 6m, 9m and 12m post treatment ]
    Testicular volumes are measured using Prader orchidometer. Prader orchidometer is a standard method to measure testicular volume. The normal range of testicular volume of each side in normal adult men is 15-25ml.

  2. Change of sperm counts by routine semen analysis [ Time Frame: Baseline and at 3m, 6m, 9m and 12m post treatment ]
    if a subject can produce an ejaculate, semen samples are collected by masturbation and analyzed according to the standard World Health Organization method.

  3. the rate of impregnating subject's wife [ Time Frame: at 3m, 6m, 9m and 12m post treatment ]
    For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or over male patients;
  • Absent or incomplete puberty development;
  • Serum testosterone values below 3.47 nmol/L by low or normal serum LH and FSH concentrations.
  • at least two or more pituitary hormone deficiencies
  • Brain MRI showed absent and thin pituitary stalk, or pituitary hypoplasia and/or ectopic posterior pituitary.

Exclusion Criteria:

  • cryptorchidism history
  • other causes of hypopituitarism or severe systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705014


Contacts
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Contact: Xue-yan Wu wuxueyan@pumch.ac.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Xue-yan Wu Peking Union Medical College Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: wuxueyan, professor,MD, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02705014    
Other Study ID Numbers: ZS-997
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by wuxueyan, Peking Union Medical College Hospital:
pituitary stalk interruption syndrome
pulsatile GnRH therapy
hypogonadotropic hypogonadism
hypopituitarism
Additional relevant MeSH terms:
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Pituitary Diseases
Hypogonadism
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gonadal Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs