Trial Condition(s):

Hypogonadism

Assessment of long term treatment with testosterone undecanoate in males with hypogonadism

Bayer Identifier:

91186

ClinicalTrials.gov Identifier:

NCT00220298

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
96
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Drs. Müller/Umbreit

Naumburg, Germany, 06618

Status
Completed
 
Locations

Praxis Fr. C. Burgkhardt

Leipzig, Germany, 04299

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04289

Status
Completed
 
Locations

Urologische Praxis Dr. Boehme

Gera, Germany, 07551

Status
Completed
 
Locations

Praxis Hr. Dipl. Med. J. Telle

Wolfsburg, Germany, 38440

Status
Completed
 
Locations

Gemeinschaftspraxis Dr. Bueber

Berlin, Germany, 12159

Status
Completed
 
Locations

Urologische Praxis Dr. Hagel

Nürnberg, Germany, 90441

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48129

Status
Completed
 
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06112

Status
Completed
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07743

Status
Completed
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Urologische Praxis Dr. Wilski

Eisenberg, Germany, 07607

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35037

Status
Completed
 
Locations

Praxis Hr. Dr. C. G. Girke

Berlin, Germany, 10249

Status
Completed
 

Trial Design