stop_circleTerminated/Withdrawn
Hypogonadism
Bayer Identifier:
91579
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Nebido versus placebo in elderly men with typical symptoms of late onset hypogonadism over a period of 54 weeks
Trial purpose
To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism
Key Participants Requirements
Sex
MaleAge
50 YearsTrial summary
Enrollment Goal
0Trial Dates
October 2008 - October 2008Phase
Phase 4Could I Receive a placebo
NoProducts
Nebido (Testosterone Undeconate, BAY86-5037)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg | Halle, 06097, Germany |
Not yet recruiting | Cardiff Clinical Research Centre | Cardiff, CF14 5GJ, United Kingdom |
Not yet recruiting | Hospital of St John and St Elizabeth | London, NW9 9NH, United Kingdom |
Not yet recruiting | Synexus Limited Birmingham | Birmingham, B15 2SQ, United Kingdom |
Not yet recruiting | Royal Free Hospital | London, NW3 2QG, United Kingdom |
Not yet recruiting | Synexus Limited Manchester | Manchester, M15 6SX, United Kingdom |
Not yet recruiting | Synexus Skandynawskie Centrum Medyczne | Wroclaw, 50-088, Poland |
Not yet recruiting | Szpital Bielanski im. Ks. Jerzego Popieluszki | Warszawa, 01-809, Poland |
Not yet recruiting | Centrum Leczenia Chorób Cywilizacyjnych | Warszawa, 02-777, Poland |
Not yet recruiting | Endocrinology Scientific Centre | Moscow, 117036, Russia |
Not yet recruiting | Central Hospital of Railway Ministry | Moscow, 123367, Russia |
Not yet recruiting | City Hospital no 25 | Volgograd, 400138, Russia |
Not yet recruiting | Paula Stradina Kliniskas Universitates slimnica | Riga, LV-1002, Latvia |
Not yet recruiting | Medizinische Einrichtungen der Universität Bonn | Bonn, 53105, Germany |
Not yet recruiting | Synexus Limited Reading | Reading, RG2 7AG, United Kingdom |
Not yet recruiting | Synexus Limited Glasgow | Glasgow, G81 2DR, United Kingdom |
Not yet recruiting | Synexus Lancashire Clinical Research | Chorley, PR7 7NA, United Kingdom |
Not yet recruiting | The Clinic | Lichfield, WS14 9JL, United Kingdom |
Not yet recruiting | NZOZ Centrum Medyczne Wola | Warszawa, 01-432, Poland |
Not yet recruiting | Klinika Andrologi i Endokrynologii Plodnosci | Lodz, 91-425, Poland |
Not yet recruiting | A.O.U. Federico II | Napoli, 80131, Italy |
Not yet recruiting | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Not yet recruiting | Azienda Policlinico Umberto I | Roma, 00155, Italy |
Not yet recruiting | State Medical Academy | Novosibirsk, 630091, Russia |
Not yet recruiting | St. Petersburg Medical University n.a. Pavlov | St. Petersburg, 197022, Russia |
Primary Outcome
- To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebodate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Change from baseline in total body massdate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- Change from baseline in fat massdate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- Change from baseline in bone mineral densitydate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- Aging Male Symptoms (AMS) rating scaledate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- International Index of Erectile Function- erectile function domain (IIEF-EF)date_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- Change in serum levels of testosterone (central laboratory)date_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
- Change in waist circumferencedate_rangeTime Frame:Baseline, week 30, week 54enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2