A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig Cell Insufficiency (Einstein-invervention)

A Randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig Cell Insufficiency (Einstein-intervention) - EINSTEIN INTERVENTION

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001452-30-DK

Enrollment

Registered

2015-09-17

Start date

2015-12-07

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leydig Cell dysfunction MedDRA version: 18.1 Level: LLT Classification code 10067734 Term: Testosterone deficiency System Organ Class: 100000004860

Interventions

Trade Name: Tostran Product Name: Tostran Product Code: G03BA03 Pharmaceutical Form: Transdermal gel INN or Proposed INN: TESTOSTERONE

Eligibility

Sex/Gender

Male

Inclusion 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 -2 standard deviations (SD) from the age-adjusted median and LH > 2 SD from the age-adjusted median. Age > 18 years and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Paternity wish at the time of inclusion* Treatment with testosterone within the last 6 months. Contraindications to testosterone treatment (prostate cancer, prostate specific antigen (PSA)> 4 microg/L), 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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Prevalence of Metabolic Syndrome, body compostion, systemic inflammation, symptoms of testosterone deficiency;Primary end point(s): Insulin sensitivity (evaluated by Oral Glucose Tolerance Test);Timepoint(s) of evaluation of this end point: Evaluated at baseline and after 26 weeks and 52 weeks of treatment and 3 months after end of study;Main Objective: Investigation of changes in insulin sensitivity after 12 months treatment with testosterone substitution	—

Measure

Time frame

Secondary Objective: Prevalence of Metabolic Syndrome, body compostion, systemic inflammation, symptoms of testosterone deficiency;Primary end point(s): Insulin sensitivity (evaluated by Oral Glucose Tolerance Test);Timepoint(s) of evaluation of this end point: Evaluated at baseline and after 26 weeks and 52 weeks of treatment and 3 months after end of study;Main Objective: Investigation of changes in insulin sensitivity after 12 months treatment with testosterone substitution

—

Secondary

Measure	Time frame
Secondary end point(s): Metabolic Syndrome (International Diabetes Federation Criteria). Body composition and bone mineral density (Dual energy X-ray absorptiometry (DXA-scan)). Systemic inflammation Plasma -adipocytokines Fasting plasma-glucose, plasma-insulin, (homeostatic model assessment-index (HOMA-index)), haemoglobin A1c. Fasting plasma-lipids Quality of life (EORTC-QLQ-30-questionnaire) ;Timepoint(s) of evaluation of this end point: Evaluated at baseline and after 26 weeks and 52 weeks of treatment and 3 months after end of study	—

Measure

Time frame

Secondary end point(s): Metabolic Syndrome (International Diabetes Federation Criteria). Body composition and bone mineral density (Dual energy X-ray absorptiometry (DXA-scan)). Systemic inflammation Plasma -adipocytokines Fasting plasma-glucose, plasma-insulin, (homeostatic model assessment-index (HOMA-index)), haemoglobin A1c. Fasting plasma-lipids Quality of life (EORTC-QLQ-30-questionnaire) ;Timepoint(s) of evaluation of this end point: Evaluated at baseline and after 26 weeks and 52 weeks of treatment and 3 months after end of study

—

Countries

Denmark

Contacts

Public ContactClinical Research Unit Information

Copenhagen University Hospital Rigshospitalet

mikkel.bandak@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026