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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220298
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone undecanoate (TU) - NebidoTM Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy and Safety of long term treatment with TU under real-life conditions [ Time Frame: Every 3 months during treatment and after final injection ]

Secondary Outcome Measures :
  1. Assessment of treatment satisfaction by patient [ Time Frame: 6,10, and 14 injections ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220298

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
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
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.

Responsible Party: Bayer Identifier: NCT00220298     History of Changes
Other Study ID Numbers: 91186
306605 ( Other Identifier: company internal )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

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