Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics
2 other identifiers
interventional
96
1 country
14
Brief Summary
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2003
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedDecember 30, 2014
December 1, 2014
4.7 years
September 16, 2005
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy and Safety of long term treatment with TU under real-life conditions
Every 3 months during treatment and after final injection
Secondary Outcomes (1)
Assessment of treatment satisfaction by patient
6,10, and 14 injections
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
Eligibility Criteria
You may qualify if:
- Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency
You may not qualify if:
- Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (14)
Unknown Facility
Nuremberg, Bavaria, 90441, Germany
Unknown Facility
Marburg, Hesse, 35037, Germany
Unknown Facility
Wolfsburg, Lower Saxony, 38440, Germany
Unknown Facility
Münster, North Rhine-Westphalia, 48129, Germany
Unknown Facility
Leipzig, Saxony, 04299, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06112, Germany
Unknown Facility
Naumburg, Saxony-Anhalt, 06618, Germany
Unknown Facility
Berlin, State of Berlin, 10249, Germany
Unknown Facility
Berlin, State of Berlin, 12159, Germany
Unknown Facility
Eisenberg, Thuringia, 07607, Germany
Unknown Facility
Gera, Thuringia, 07551, Germany
Unknown Facility
Jena, Thuringia, 07740, Germany
Unknown Facility
Jena, Thuringia, 07743, Germany
Unknown Facility
Leipzig, 04289, Germany
Related Publications (1)
Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
February 1, 2003
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
December 30, 2014
Record last verified: 2014-12