A clinical trial for the effects of testosterone replacement therapy in male patients with hypogonadism on arterial function markers

Phase 1

• Conditions: Male patients with hypogonadism; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005179-10-GR
• Lead Sponsor: Charalampos Vlachopoulos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1) Providing written consent prior to effecting any procedure of the study 2)Male patients 35-64 years 3) Diagnosis of hypogonadism. The deficiency of testosterone should be demonstrated by clinical features, as assessed by medical history, clinical examination and ADAM questionnaire (Annex B) and confirmed by two separate measurements of morning blood testosterone [either total testosterone < 350 ng / dL (12 nmol / L) or free testosterone < 8 ng / dL (270 pmol / L)].
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Participation in the design and conduct of the study 2) Participation in another study in the period between the time of the baseline measurement and evaluation which will take place during the observation period, except for participation in registries or epidemiological studies (surveys) that do not affect hypogonadism therapy 3) Female sex 4) Patients > 64 years old or patients < 35 years old 5) Patients with known cardiovascular disease 6) Androgen dependent prostate cancer or male breast gland 7) History or presence of liver tumors 8) Hypersensitivity to the active substance or to any excipient of injectable long-acting testosterone undecanoate solution 9)PSA > = 4 ng / ml 10) Severe symptoms of lower urinary tract due to benign prostatic hyperplasia 11) Malignancy, autoimmune disease or any other modern illness (eg, neurological or psychiatric illness), which could affect or prevent the study to be completed according to the researcher's view 12) Polycythemia / or hematocrit > 50% 13) Overt endocrine disease e.g. uncontrolled thyroid disorders or disorders of the hypothalamic-pituitary adrenal axis (except diabetes mellitus) 14) Contemporary or recent (last year) use of steroids (anabolic or androgenic), ACTH, 5-alpha reductase inhibitors, 5-phosphodiesterase inhibitors, beta-blockers and drugs that are known to affect the testosterone metabolism 15) Severe renal impairment (GFR < 30 ml / min / 1.73m2) 16) Severe hepatic impairment, defined as liver cirrhosis, increased transaminases (AST or ALT) or alkaline phosphatase more than three times the upper normal limit or hyperbilirubinemia 17) Severe obstructive sleep apnea 18) Infertility or desire for immediate procreation (within 2 years of study entry) 19) Simultaneous use of oral vitamin K antagonists (acenocoumarol, warfarin) 20) Patients with restrictions on the use of intramuscular injections as in patients with acquired or congenital abnormalities of blood coagulation 21) Life expectancy less than 3 years 22) Incompliance with the study protocol e.g. due to scheduled move away from the place of the study or abuse of alcohol or drug use.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified