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
  Purpose

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


Condition Intervention Phase
Hypogonadism
Drug: Testosterone undecanoate (TU) - NebidoTM
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Assessment of treatment satisfaction by patient [ Time Frame: 6,10, and 14 injections ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: February 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220298

Locations
Germany
Nürnberg, Bayern, Germany, 90441
Marburg, Hessen, Germany, 35037
Wolfsburg, Niedersachsen, Germany, 38440
Münster, Nordrhein-Westfalen, Germany, 48129
Halle, Sachsen-Anhalt, Germany, 06112
Naumburg, Sachsen-Anhalt, Germany, 06618
Leipzig, Sachsen, Germany, 04299
Jena, Thueringen, Germany, 07740
Jena, Thueringen, Germany, 07743
Eisenberg, Thüringen, Germany, 07607
Gera, Thüringen, Germany, 07551
Berlin, Germany, 10249
Berlin, Germany, 12159
Leipzig, Germany, 04289
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00220298     History of Changes
Other Study ID Numbers: 91186, 306605
Study First Received: September 16, 2005
Last Updated: January 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 18, 2014