Effects of Medications in Patients With Hypogonadism

Sponsor

Gulhane School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01601327

Collaborator

(none)

119

Enrollment

Locations

Arms

Duration (Months)

59.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Hypogonadotropic Hypogonadism	Drug: Testosterone enanthate (Sustanon 250 mg) Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) Drug: Testosteron gel (Testojel 50 mg)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

119 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: hypogonadism, treatment 77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin	Drug: Testosterone enanthate (Sustanon 250 mg) Twenty-eight patients were treated with testosterone enanthate (TE), Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) twenty-five patients were treated with human chorionic gonadotropin (hCG) Drug: Testosteron gel (Testojel 50 mg) Twenty-four patients were treated with testosterone gel (TG).
No Intervention: Control group 42 healthy controls	Drug: Testosterone enanthate (Sustanon 250 mg) Twenty-eight patients were treated with testosterone enanthate (TE),

Arm

Intervention/Treatment

Other: hypogonadism, treatment

77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin

Drug: Testosterone enanthate (Sustanon 250 mg)

Twenty-eight patients were treated with testosterone enanthate (TE),

Drug: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)

twenty-five patients were treated with human chorionic gonadotropin (hCG)

Drug: Testosteron gel (Testojel 50 mg)

Twenty-four patients were treated with testosterone gel (TG).

No Intervention: Control group

42 healthy controls

Drug: Testosterone enanthate (Sustanon 250 mg)

Twenty-eight patients were treated with testosterone enanthate (TE),

Outcome Measures

Primary Outcome Measures

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

Effect of testosterone enanthate on testis volumes [3 years]
Effect of testosterone gel on testis volumes [3 years]
Effect of human chorionic gonadotrophin on testis volumes [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane School of Medicine Dep. of Endocrine and Metabolism	Ankara		Turkey	06018
2	Gulhane School of Medicine Dep. of Endocrinology and Metabolism	Ankara		Turkey	06018