check_circleStudy Completed

Hypogonadism

Bayer Identifier:

91186

ClinicalTrials.gov Identifier:

NCT00220298

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of long term treatment with testosterone undecanoate in males with hypogonadism

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

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


  • - 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.

Trial summary

Enrollment Goal
96
Trial Dates
February 2003 - October 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Drs. Müller/UmbreitNaumburg, 06618, Germany
Completed
Praxis Fr. C. BurgkhardtLeipzig, 04299, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04289, Germany
Completed
Urologische Praxis Dr. BoehmeGera, 07551, Germany
Completed
Praxis Hr. Dipl. Med. J. TelleWolfsburg, 38440, Germany
Completed
Gemeinschaftspraxis Dr. BueberBerlin, 12159, Germany
Completed
Urologische Praxis Dr. HagelNürnberg, 90441, Germany
Completed
Universitätsklinikum MünsterMünster, 48129, Germany
Completed
Med. Fakultät der Martin-Luther-Universität Halle-WittenbergHalle, 06112, Germany
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07743, Germany
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Completed
Urologische Praxis Dr. WilskiEisenberg, 07607, Germany
Completed
Gemeinschaftspraxis Dr. BueberBerlin, 12159, Germany
Completed
Gemeinschaftspraxis Dr. BueberBerlin, 12159, Germany
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35037, Germany
Completed
Praxis Hr. Dr. C. G. GirkeBerlin, 10249, Germany

Primary Outcome

  • Efficacy and Safety of long term treatment with TU under real-life conditions
    date_rangeTime Frame:
    Every 3 months during treatment and after final injection
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Assessment of treatment satisfaction by patient
    date_rangeTime Frame:
    6,10, and 14 injections
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.