Effects of Medications in Patients With Hypogonadism

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

Official title:

Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601327
• Other study ID #: 01052012
• Status: Completed
• Phase: Phase 4
• First received: May 1, 2012
• Last updated: May 17, 2012
• Start date: January 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria: hypogonadotropic hypogonadism

• decreased serum testosterone concentration below the normal range (serum T < 300ng/dL),

• FSH and LH levels within or below the normal range,

• absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,

• normal smell test and normal karyotypes

Exclusion Criteria:

• previous androgen treatment,

• history of smoking,

• presence of bilateral anorchia,

• intellectual deficiency,

• diabetes mellitus,

• arterial hypertension or dyslipoproteinemia,

• medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

Participants with iron, vitamin B12 or folate deficiency were also excluded.

Study Design

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

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism

Intervention

Drug:
• Testosterone enanthate (Sustanon 250 mg)
Twenty-eight patients were treated with testosterone enanthate (TE),
• Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)
twenty-five patients were treated with human chorionic gonadotropin (hCG)
• Testosteron gel (Testojel 50 mg)
Twenty-four patients were treated with testosterone gel (TG).

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Dep. of Endocrine and Metabolism	Ankara
Turkey	Gulhane School of Medicine Dep. of Endocrinology and Metabolism	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.		3 years	Yes
Primary	Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.		3 years	Yes
Primary	Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.		3 years	Yes
Secondary	Effect of testosterone enanthate on testis volumes		3 years	Yes
Secondary	Effect of testosterone gel on testis volumes		3 years	Yes
Secondary	Effect of human chorionic gonadotrophin on testis volumes		3 years	Yes