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Einstein: Study of Testosterone vs Placebo in Testicular Cancer Survivors

Sponsor
Mikkel Bandak (Other)
Overall Status
Completed
CT.gov ID
NCT02991209
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
30.9
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tostran 2%

1 years treatment with transdermal Tostran 2%

Drug: Testosterone
Other Names:
  • Tostran

    		•
    Placebo Comparator: Placebo

    1 years treatment with placebo gel

    Drug: Placebos

    Outcome Measures

    Primary Outcome Measures

    1. Changes in insulin sensitivity [1 year]

      Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)

    Secondary Outcome Measures

    1. Changes in fasting plasma lipids between baseline and 52 weeks [1 year]

    2. Changes in BMD and fat percent between baseline 52 weeks [1 year]

      BMD and body composition evaluated by DXA-scan

    3. Changes in systemic inflammation between baseline and 52 weeks [1 year]

      Analysis of tnf-alfa, interleukine 1-beta, interleukine 1, interleukine 6, interleukine 8

    4. Changes in plasma-adipocytokines between baseline and 52 weeks [1 year]

    5. Changes in fasting plasma glucose between baseline and 52 weeks [1 year]

    6. Changes in Quality of life between baseline and 52 weeks. [1 year]

      EORTC-QLQ C30

    7. Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0 [1 year]

    8. Changes in prevalence of metabolic syndrome between baseline and 52 weeks [1 year]

      According to NCEP-ATPIII criteria

    9. Changes in haemoglobin A1c between baseline and 52 weeks [1 year]

    10. Changes in plasma insulin between baseline and 52 weeks [1 year]

    11. Changes in fatigue between baseline and 52 weeks [1 year]

      MFI-20 (Multidimensional Fatigue Inventory)

    12. Changes in Anxiety and depression between baseline and 52 weeks [1 year]

      HADS (Hospital Anxiety and Depression Scale)

    13. Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks [1 year]

      IIEF-15 (International Index of Erectile Dysfunction)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Mikkel Bandak

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mikkel Bandak, MD, Research Fellow, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT02991209
    Other Study ID Numbers:
    • 010815Testis
    First Posted:
    Dec 13, 2016
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Testicular Neoplasms
    Metabolic Syndrome
    Testosterone

    Study Results

    No Results Posted as of Mar 6, 2020