Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00220298
First received: September 16, 2005
Last updated: January 22, 2013
Last verified: January 2013

September 16, 2005
January 22, 2013
February 2003
October 2007   (final data collection date for primary outcome measure)
Efficacy and Safety of long term treatment with TU under real-life conditions [ Time Frame: Every 3 months during treatment and after final injection ] [ Designated as safety issue: Yes ]
Efficacy and Safety of long term treatment with TU under real-life conditions
Complete list of historical versions of study NCT00220298 on ClinicalTrials.gov Archive Site
Assessment of treatment satisfaction by patient [ Time Frame: 6,10, and 14 injections ] [ Designated as safety issue: No ]
Assessment of treatment satisfaction by patient
Not Provided
Not Provided
 
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

This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadism
Drug: Testosterone undecanoate (TU) - NebidoTM
Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
Experimental: Arm 1
Intervention: Drug: Testosterone undecanoate (TU) - NebidoTM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency

Exclusion Criteria:

  • 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.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00220298
91186, 306605
No
Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP