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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01601327
Other study ID # 01052012
Secondary ID
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


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
See also
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Terminated NCT01165619 - Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders N/A
Completed NCT01914172 - Health Needs of Patients With Kallmann Syndrome N/A
Completed NCT02042638 - The Effects of Gonadotropin Replacement Therapy in Patients With Hypogonadism N/A
Active, not recruiting NCT02310074 - Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism Phase 4
Completed NCT01758094 - Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism N/A
Completed NCT00493961 - Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism Phase 1
Recruiting NCT05569577 - An Open Labeled RCT on the Effect of Additional hCG Injection for LPS on Pregnancy Outcomes in IHH Patients N/A