Study of Testosterone vs Placebo in Testicular Cancer Survivors
Einstein
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 25, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMarch 6, 2020
March 1, 2020
2.6 years
November 25, 2016
March 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in insulin sensitivity
Evaluation of changes in two hours plasma glucose investigated by Oral Glucose Tolerance Test (OGTT)
1 year
Secondary Outcomes (13)
Changes in fasting plasma lipids between baseline and 52 weeks
1 year
Changes in BMD and fat percent between baseline 52 weeks
1 year
Changes in systemic inflammation between baseline and 52 weeks
1 year
Changes in plasma-adipocytokines between baseline and 52 weeks
1 year
Changes in fasting plasma glucose between baseline and 52 weeks
1 year
- +8 more secondary outcomes
Study Arms (2)
Tostran 2%
EXPERIMENTAL1 years treatment with transdermal Tostran 2%
Placebo
PLACEBO COMPARATOR1 years treatment with placebo gel
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mikkel Bandaklead
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (4)
Kreiberg M, Jorgensen N, Juul A, Lauritsen J, Oturai P, Helge JW, Christensen JF, Aksglaede L, Schauer T, Wagner T, Rosenvilde J, Grunwald E, Dehlendorff C, Daugaard G, Bandak M. A randomized double-blind single center study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). Clin Genitourin Cancer. 2022 Oct;20(5):404-414. doi: 10.1016/j.clgc.2022.04.017. Epub 2022 May 2.
PMID: 35701334DERIVEDHojer EG, Kreiberg M, Dehlendorff C, Jorgensen N, Juul A, Lauritsen J, Wagner T, Rosenvilde J, Daugaard G, Bandak M. Effect of Testosterone Replacement Therapy on Quality of Life and Sexual Function in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency: Results From a Randomized Double-blind Trial. Clin Genitourin Cancer. 2022 Aug;20(4):334-343. doi: 10.1016/j.clgc.2022.03.012. Epub 2022 Apr 1.
PMID: 35514022DERIVEDPriskorn L, Kreiberg M, Bandak M, Lauritsen J, Daugaard G, Petersen JH, Aksglaede L, Juul A, Jorgensen N. Testicular cancer survivors have shorter anogenital distance that is not increased by 1 year of testosterone replacement therapy. Hum Reprod. 2021 Aug 18;36(9):2443-2451. doi: 10.1093/humrep/deab162.
PMID: 34223605DERIVEDBandak M, Jorgensen N, Juul A, Lauritsen J, Kreiberg M, Oturai PS, Helge JW, Daugaard G. A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). BMC Cancer. 2017 Jul 3;17(1):461. doi: 10.1186/s12885-017-3456-5.
PMID: 28673265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Research Fellow
Study Record Dates
First Submitted
November 25, 2016
First Posted
December 13, 2016
Study Start
November 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
March 6, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share