Study of Testosterone vs Placebo in Testicular Cancer Survivors

Metabolic Syndrome Clinical Trial

— Einstein  

Official title:

A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02991209
• Other study ID #: 010815Testis
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: June 2019

Study information

• Verified date: March 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a single-center, randomized, double-blind, placebo-controlled intervention study, designed to evaluate the effect of testosterone replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency.

70 subjects will be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited for an information meeting where informed consent is signed. If a subject is suitable for participation in the trial, subject will be randomized to testosterone replacement therapy or placebo and baseline investigations will be performed. Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at the end of treatment (52 weeks) and three months after completion of treatment (week 64).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leydig Cell Failure in Adult
• Metabolic Syndrome
• Testicular Cancer
• Testicular Neoplasms

Intervention

Drug:
• Testosterone

• Placebos

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mikkel Bandak

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in insulin sensitivity	Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)	1 year
Secondary	Changes in fasting plasma lipids between baseline and 52 weeks		1 year
Secondary	Changes in BMD and fat percent between baseline 52 weeks	BMD and body composition evaluated by DXA-scan	1 year
Secondary	Changes in systemic inflammation between baseline and 52 weeks	Analysis of tnf-alfa, interleukine 1-beta, interleukine 1, interleukine 6, interleukine 8	1 year
Secondary	Changes in plasma-adipocytokines between baseline and 52 weeks		1 year
Secondary	Changes in fasting plasma glucose between baseline and 52 weeks		1 year
Secondary	Changes in Quality of life between baseline and 52 weeks.	EORTC-QLQ C30	1 year
Secondary	Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0		1 year
Secondary	Changes in prevalence of metabolic syndrome between baseline and 52 weeks	According to NCEP-ATPIII criteria	1 year
Secondary	Changes in haemoglobin A1c between baseline and 52 weeks		1 year
Secondary	Changes in plasma insulin between baseline and 52 weeks		1 year
Secondary	Changes in fatigue between baseline and 52 weeks	MFI-20 (Multidimensional Fatigue Inventory)	1 year
Secondary	Changes in Anxiety and depression between baseline and 52 weeks	HADS (Hospital Anxiety and Depression Scale)	1 year
Secondary	Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks	IIEF-15 (International Index of Erectile Dysfunction)	1 year