Study of Testosterone vs Placebo in Testicular Cancer Survivors

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The overall purpose of the study is to evaluate the effect of 12 months testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in order to reduce the risk of cardiovascular disease.

The primary study objective is to evaluate changes in insulin sensitivity. The secondary study objective is to evaluate changes in the prevalence of metabolic syndrome, body composition, systemic inflammation and symptoms of testosterone deficiency.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mikkel Bandak
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Signed informed consent.

• Previous treatment for testicular cancer.

• No signs of relapse 1 year after last treatment (orchiectomy, radiotherapy, chemotherapy).

• Free testosterone < the age-adjusted median and > -2 standard deviations (SD) from the age-adjusted median and LH > 2 SD from the age-adjusted median.

Exclusion Criteria:

• Treatment with testosterone within the last 6 months.

• Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)> 4 ng/mL), malignancy suspect prostate by digital rectal examination, Alanine aminotransferase (ALT)> 1.5 upper reference level, Erythrocyte Volume Fraction (EVF) > 50%.

• Breast cancer.

• Symptomatic obstructive sleep apnoea syndrome

• Heart failure > NYHA II.

• Uncontrolled hypertension: (Systolic blood pressure > 160 mm Hg despite antihypertensive treatment, measured at two separate occasions)

• Inability to understand information about the trial

• Participation in any other clinical trial

• Allergy for the active substance or additives in Tostran or placebo.

• Known diabetes mellitus, or diabetes mellitus detected at screening or baseline tests.