check_circleStudy Completed
Male, Hypogonadism
Bayer Identifier:
14203
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Use of Nebido® to assess tolerability and treatment outcomes in daily clinical practice
Trial purpose
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
1493Trial Dates
October 2006 - July 2010Phase
N/ACould I Receive a placebo
NoProducts
Nebido (Testosterone Undeconate, BAY86-5037)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Italy | |
Terminated | Many Locations, Lithuania | |
Completed | Many Locations, Hong Kong | |
Completed | Many Locations, Malaysia | |
Completed | Many Locations, Philippines | |
Completed | Many Locations, Thailand | |
Completed | Many Locations, Saudi Arabia | |
Completed | Many Locations, Moldova | |
Terminated | Many Locations, Jordan | |
Terminated | Many Locations, Lebanon | |
Terminated | Many Locations, Malta | |
Completed | Many Locations, Germany | |
Completed | Many Locations, United Kingdom | |
Terminated | Many Locations, Spain | |
Terminated | Many Locations, Mexico | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Australia | |
Completed | Many Locations, Bulgaria | |
Completed | Many Locations, Austria | |
Terminated | Many Locations, Turkey | |
Completed | Many Locations, Colombia | |
Completed | Many Locations, Russia | |
Completed | Many Locations, Ukraine | |
Completed | Many Locations, Indonesia | |
Completed | Many Locations, Korea, Republic Of | |
Completed | Many Locations, Taiwan | |
Terminated | Many Locations, Estonia | |
Completed | Many Locations, Singapore | |
Terminated | Many Locations, Latvia | |
Terminated | Many Locations, Slovenia | |
Completed | Many Locations, Romania | |
Completed | Many Locations, Kazakhstan | |
Completed | Many Locations, Macedonia | |
Terminated | Many Locations, Malta |
Primary Outcome
- Adverse events, adverse drug reactions, patient reported tolerabilitydate_rangeTime Frame:during 4 injection intervalsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observationdate_rangeTime Frame:after 4 injection intervalsenhanced_encryptionNoSafety Issue:
- Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observationdate_rangeTime Frame:after 4 injection intervalsenhanced_encryptionNoSafety Issue:
- Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observationdate_rangeTime Frame:after 4 injection intervalsenhanced_encryptionNoSafety Issue:
- Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)date_rangeTime Frame:after 4 injection intervalsenhanced_encryptionNoSafety Issue:
- Treatment continuation ratedate_rangeTime Frame:after 4 injection intervalsenhanced_encryptionNoSafety Issue:
- Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)date_rangeTime Frame:during 4 injection intervalsenhanced_encryptionYesSafety Issue:
- Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)date_rangeTime Frame:during 4 injection intervalsenhanced_encryptionYesSafety Issue:
- Digital rectal examinationdate_rangeTime Frame:during 4 injection intervalsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A