Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy

Gulhane School of Medicine

Status and phase: Completed; Phase 4

Conditions: Hypogonadotrophic Hypogonadism

Treatments: Drug: Testosteron 50 mg transdermal gel; Drug: Testosterone 250mg injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02171390

GSM-042014

Details and patient eligibility

About

The study searched for answers to two questions

1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?
2. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?

Enrollment: 130 patients

Sex: Male

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men
• Treatment naive
• Hypogonadotrophic hypogonadism

Exclusion criteria

• Previous history of androgen replacement
• Chronic metabolic disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Daily testosterone transdermal gel

Active Comparator group

Treatment:

Drug: Testosteron 50 mg transdermal gel

Injectable Testosterone esters

Active Comparator group

Description:

Testosteron 250mg injection per 3-4 weeks for 6 months

Treatment:

Drug: Testosterone 250mg injection