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

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02310074
• Other study ID #: ruijin-GnRH pump-002
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 3, 2014
• Last updated: January 31, 2015
• Start date: January 2010

Study information

• Verified date: December 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 35 Years

Eligibility

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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism

Intervention

Drug:
• Pulsatile Gonadotropin Releasing Hormone

• Human chorionic gonadotropin
Human chorionic gonadotropin (hCG)
• Urinary Follicle-Stimulating Hormone
Urinary Follicle-Stimulating Hormone (uFSH)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	testicular volume		18 months	No
Other	prostatic volume		18 months	No
Other	Tanner stage for pubic hair		18 months	No
Other	Tanner stage for genital		18 months	No
Other	serum hormone levels	especially serum testosterone, LH, and FSH levels	18 months	No
Other	sperm concentration per ejaculate		18 months	No
Other	adverse events		18 months	Yes
Primary	pregnancy in the female partner		18 months	No
Secondary	first appearance of sperm (month after treatment)		18 months	No
Secondary	first time with sperm density>1*10^6/ml(month after treatment)		18 months	No
Secondary	first time with sperm density>15*10^6/ml(month after treatment)		18 months	No