EUCTR2011-005439-20-SE
Active, Not Recruiting
Phase 1
A randomised, double-blind study to investigate the effects of intramuscular testosterone undecanoate (Nebido®) on anemia treatment in testosterone deficient men undergoing hemodialysis. - DiaTest
Dept of Renal medicine0 sites40 target enrollmentDecember 5, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypogonadal males undergoing hemodialysis (HD).
- Sponsor
- Dept of Renal medicine
- Enrollment
- 40
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ambulant male HD patients (\>3 months) at least 18 yrs of age
- •Signed written informed consent obtained
- •Screening non\-fasting testosterone \<12 nmol/L in two consecutive tests (\>2 days apart) on a HD day.
- •Stable ESA dose within the interval equivalent to 25\-300 I.U. kg/week during the 6 weeks before inclusion
- •Mean pre\-dialysis Hb during screening in the interval 90\-120 g/l.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Contraindication to treatment with Nebido®, elevation of prostate specific antigen (PSA \=4\.5 ng/ml if \<70 yr and \=6\.5 ng/ml if \>70 yr) or severe symptomatic benign prostatic hyperplasia
- •Known acute bacterial infection requiring antibiotic treatment
- •Clinically significant overt bleeding
- •Active malignancy
- •Patients taking prednisolone in doses \>10 mg
- •Antiandrogens or estrogen medication
- •Uncontrolled epilepsia
- •Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range
- •Planned living donor kidney transplantation
- •Acute coronary syndrome or stroke within the 6 months prior to screening
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 1
ASC-201 Plus Trifluridine/Tipiracil for the Treatment of Advanced Gastric CancerAdvanced Gastric Cancer.MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]EUCTR2021-003799-15-ESAscelia Pharma AB139
Completed
N/A
A randomised double-blind trial to investigate the efficacy of intra-articular bupivacaine for pain relief following ankle arthroscopySigns and Symptoms: PainSigns and SymptomsPainISRCTN07238689Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)48
Active, Not Recruiting
N/A
Double-blind, randomised trial to investigate the antihypertensive and metabolic effects of candesartan in insulin-resistant obese patients with a hypertension not adequately controlled by previous beta-blocker or calcium channel blockerEUCTR2006-001998-25-DETakeda Pharma GmbH
Terminated
Phase 4
A randomized, double-blinded study investigating the safety and efficacy of daily low-dose oral fluconazole versus weekly fluconazole in the treatment of chronic vulvovaginal candidiasisChronic vulvovaginal candidiasisSkin - Dermatological conditionsInfection - Other infectious diseasesRenal and Urogenital - Other renal and urogenital disordersACTRN12614001258640Royal North Shore Hospital200
Active, Not Recruiting
N/A
A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from lumbosacral radiculopathyeuropathic pain from lumbosacral radiculopathyMedDRA version: 12.0Level: LLTClassification code 10037779Term: RadiculopathyEUCTR2009-012836-33-DEGlaxoSmithKline Research & Development Limited142