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Study of Testosterone vs Placebo in Testicular Cancer Survivors (Einstein)

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ClinicalTrials.gov Identifier: NCT02991209
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Mikkel Bandak, Rigshospitalet, Denmark

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
Metabolic Syndrome Testicular Cancer Leydig Cell Failure in Adult Drug: Testosterone Drug: Placebos 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).

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Study Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tostran 2%
1 years treatment with transdermal Tostran 2%
Drug: Testosterone
Other Name: Tostran

Placebo Comparator: Placebo
1 years treatment with placebo gel
Drug: Placebos



Primary Outcome Measures :
  1. Changes in insulin sensitivity [ Time Frame: 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 [ Time Frame: 1 year ]
  2. Changes in BMD and fat percent between baseline 52 weeks [ Time Frame: 1 year ]
    BMD and body composition evaluated by DXA-scan

  3. Changes in systemic inflammation between baseline and 52 weeks [ Time Frame: 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 [ Time Frame: 1 year ]
  5. Changes in fasting plasma glucose between baseline and 52 weeks [ Time Frame: 1 year ]
  6. Changes in Quality of life between baseline and 52 weeks. [ Time Frame: 1 year ]
    EORTC-QLQ C30

  7. Adverse events evaluated by the Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: 1 year ]
  8. Changes in prevalence of metabolic syndrome between baseline and 52 weeks [ Time Frame: 1 year ]
    According to NCEP-ATPIII criteria

  9. Changes in haemoglobin A1c between baseline and 52 weeks [ Time Frame: 1 year ]
  10. Changes in plasma insulin between baseline and 52 weeks [ Time Frame: 1 year ]
  11. Changes in fatigue between baseline and 52 weeks [ Time Frame: 1 year ]
    MFI-20 (Multidimensional Fatigue Inventory)

  12. Changes in Anxiety and depression between baseline and 52 weeks [ Time Frame: 1 year ]
    HADS (Hospital Anxiety and Depression Scale)

  13. Changes in Symptoms of low levels of testosterone, erectile dysfunction between baseline and 52 weeks [ Time Frame: 1 year ]
    IIEF-15 (International Index of Erectile Dysfunction)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991209


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Mikkel Bandak
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mikkel Bandak, MD, Research Fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02991209    
Other Study ID Numbers: 010815Testis
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Testicular Neoplasms
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs