Testosterone replacement in young male cancer survivors

Phase 1

Conditions: Borderline low levels of testosterone in male cancer survivors who have previously had leukaemia, lymphoma or testicular cancer.
MedDRA version: 14.0Level: LLTClassification code 10047900Term: Weight lossSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-000677-31-GB

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 268

Inclusion Criteria

Able and willing to provide written informed consent • Able and willing to comply with all study procedures • Male • Aged between 25 and 50 years • Post-pubertal • Previous testicular cancer, lymphoma or leukaemia • At least 12 months from completion of curative treatment for testicular cancer, lymphoma or leukaemia • A serum testosterone level =7nmol/l and =12nmol/l • If taking any hormone replacement, on stable doses for the last 6 months
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 268
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• Body Mass Index (BMI) of more than 35 kg/m2 • Currently receiving corticosteroid therapy or likely to receive corticosteroids during the trial • Previous testosterone treatment within 12 months of entering the trial • Previous allogeneic bone marrow transplant • A history of hormone-dependent cancer (e.g. prostate or breast cancer) • A history of primary liver tumour • Previous history of hypercalcaemia • Nephrotic syndrome • Diabetes mellitus (type 1 or type 2) • Hypertension • Heart failure • Liver disease • Renal failure • Deep vein thrombosis • Systolic blood pressure > 100 mmHg diastolic or > 160 mmHg systolic after resting and three measurements - Clinically significant abnormal PSA or FBC • Other severe concurrent disease or mental disorder which would affect the collection of study measurements