Effects of Medications in Patients With Hypogonadism

Phase 4

Completed

• Conditions: Idiopathic Hypogonadotropic Hypogonadism
• Interventions: Drug: Testosterone enanthate (Sustanon 250 mg); Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU); Drug: Testosteron gel (Testojel 50 mg)

• Registration Number: NCT01601327
• Lead Sponsor: Gulhane School of Medicine

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-17
• Last Update Submitted: 2012-05-17
• Study First Posted: 2012-05-18
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hypogonadism, treatment	Testosterone enanthate (Sustanon 250 mg)	77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
hypogonadism, treatment	Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)	77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
Control group	Testosterone enanthate (Sustanon 250 mg)	42 healthy controls
hypogonadism, treatment	Testosteron gel (Testojel 50 mg)	77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin

Primary Outcome Measures

Name	Time	Method
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.	3 years

Secondary Outcome Measures

Name	Time	Method
Effect of testosterone gel on testis volumes	3 years
Effect of human chorionic gonadotrophin on testis volumes	3 years
Effect of testosterone enanthate on testis volumes	3 years

Trial Locations

Locations (2)

Gulhane School of Medicine Dep. of Endocrine and Metabolism; 🇹🇷 Ankara, Turkey

Gulhane School of Medicine Dep. of Endocrinology and Metabolism; 🇹🇷 Ankara, Turkey