Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice - Full Text View

Purpose

This is an observational study with a drug called Nebido®, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido® have already been thoroughly evaluated through well controlled clinical trials.

The main purpose of this observational study is to confirm the established safety profile of Nebido® in daily clinical practice.

Condition

Hypogonadism

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study

Official Title:	International, Multi-Center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)

Further study details as provided by Bayer:

Study Start Date:

October 2006

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

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization

Exclusion Criteria:

Patients presenting with contraindications as stated in the product information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410306

Contacts


Contact: Bayer Schering Pharma AG, Germany, Medical Affairs	+493046811800

Locations


Australia
		Not yet recruiting
	Melbourne, Australia

Austria
		Recruiting
	Salzburg, Austria

Colombia
		Recruiting
	Bogota, Colombia

Germany
		Recruiting
	Muenster, Germany

Indonesia
		Active, not recruiting
	Jakarta, Indonesia

Korea, Republic of
		Recruiting
	Seongnam-Si, Korea, Republic of

Macedonia, The Former Yugoslav Republic of
		Recruiting
	Skopje, Macedonia, The Former Yugoslav Republic of

Romania
		Recruiting
	Bucharest, Romania

Russian Federation
		Recruiting
	Moscow, Russian Federation

Ukraine
		Recruiting
	Kiev, Ukraine

United Kingdom
		Not yet recruiting
	Barnsley, United Kingdom

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Schering Pharma AG, Germany, Medical Affairs	+493046811800

More Information

Study ID Numbers:	39732
First Received:	December 11, 2006
Last Updated:	August 17, 2007
ClinicalTrials.gov Identifier:	NCT00410306
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Germany: Federal Institute for Drugs and Medical Devices; Macedonia: Ministry of Health; Drugs Bureau Russia: Federal Service of Control and Supervision in the field of Healthcare; Romania: State Institute for Drug Control; Austria: Federal Ministry for Health and Women; Ukraine: Ministry of Health; Australia: Human Research Ethics Committee; Indonesia: National Agency for Drug and Food Control; Korea: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:

Hypogonadism

Nebido®

Testosterone

Observational Study

Study placed in the following topic categories:

Testosterone

Hypogonadism

Gonadal Disorders

Endocrine System Diseases

Methyltestosterone

Endocrinopathy

Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00410306