The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

Gulhane School of Medicine

Status and phase: Completed; Phase 4

Conditions: Hypogonadotrophic Hypogonadism

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01533129

GSM-022011

Details and patient eligibility

About

The study searched for answers to two questions

1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.

Enrollment: 106 patients

Sex: Male

Ages: 18 to 26 years old

Volunteers: No 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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106 participants in 2 patient groups

Daily testosterone transdermal gel

Active Comparator group

Treatment:

Drug: Testogel 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