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

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705014
• Other study ID #: ZS-997
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2016
• Last updated: March 6, 2016
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2016
• Source: Peking Union Medical College Hospital
• Contact: Xue-yan Wu
• Email: wuxueyan[@]pumch.ac.cn
• Is FDA regulated: No
• Health authority: China:Chinese Ethics Committee of Registering Clinical Trials
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

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).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Shao WM, Bai WJ, Chen YM, Liu L, Wang YJ. [Micropump infusion of gonadorelin in the treatment of hypogonadotropic hypogonadism in patients with pituitary stalk interruption syndrome: cases analysis and literature review]. Beijing Da Xue Xue Bao. 2014 Aug — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum Luteinizing Hormone(LH) value	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.	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	No
Primary	Change of serum Follicle-Stimulating Hormone (FSH) value	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.	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	No
Primary	Change of serum total testosterone value	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.	Baseline and at 1m,3m, 6m, 9m and 12m post treatment.	No
Secondary	Change of testicular volume	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.	Baseline and at 1m,3m, 6m, 9m and 12m post treatment	No
Secondary	Change of sperm counts by routine semen analysis	if a subject can produce an ejaculate, semen samples are collected by masturbation and analyzed according to the standard World Health Organization method.	Baseline and at 3m, 6m, 9m and 12m post treatment	No
Secondary	the rate of impregnating subject's wife	For subjects who have sex partners, pregnancies are documented according to subjects' reports after treatment.	at 3m, 6m, 9m and 12m post treatment	No