Clinical trial · Interventional
Study of Testosterone vs Placebo in Testicular Cancer Survivors
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
NCT02991209CI-TRIAL-00043864EinsteincompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leydig Cell Failure in Adult | — | UNRESOLVED | — |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebos | Drug | — | UNRESOLVED |
| Testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tostran 2%
- description
- 1 years treatment with transdermal Tostran 2%
- interventionNames
- Drug: Testosterone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1 years treatment with placebo gel
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
- Changes in insulin sensitivity
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (4)
- DERIVEDKreiberg 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 35701334
- DERIVEDHojer 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 35514022
- DERIVEDPriskorn 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 34223605
- DERIVEDBandak 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 28673265