Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men - Full Text View

Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men (TU)

This study has been completed.

First Received on April 27, 2007. Last Updated on September 21, 2010 History of Changes

Sponsor:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00467870

Purpose

To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.

Condition	Intervention	Phase
Hypogonadism Primary Hypogonadism Secondary Hypogonadism	Drug: Testosterone Undecanoate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Two-Arm, Open-Label, Randomized, Multi-Center Pharmacokinetic and Long-Term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

To evaluate the pharmacokinetics of TU [ Time Frame: July 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare serum levels of DHT, E2, and SHBG to simultaneous levels of serum total testosterone at steady state [ Time Frame: July 2009 ] [ Designated as safety issue: Yes ]

Enrollment:	500
Study Start Date:	March 2006
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 750 mg dose	Drug: Testosterone Undecanoate 750 mg or 1000 mg dose
Experimental: 2 1000 mg dose	Drug: Testosterone Undecanoate 750 mg or 1000 mg dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male with primary or secondary hypogonadism at least 18 years of age
Morning screening serum testosterone concentration < 300 ng/dL

Exclusion Criteria:

History of carcinoma, tumors or induration of the prostate or the male mammary gland including suspicion thereof
Insulin-dependent diabetes mellitus
Use of steroidal anabolic drugs or supplements by any application method within the 28-days prior to the first administration of the study drug and throughout the study (exclusive of the administered study drug)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467870

Locations

United States, Massachusetts
Indevus Pharmaceuticals, Inc.
Lexington, Massachusetts, United States, 02421

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators

Study Director:

Indevus Pharmaceuticals, Inc.

Sponsor GmbH

More Information

No publications provided

Responsible Party:	Mark Roessel, VP Regulatory Affairs, Indevus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00467870 History of Changes
Other Study ID Numbers:	IP157-001
Study First Received:	April 27, 2007
Last Updated:	September 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

investigational
testosterone
testosterone undecanoate
TU

Hypogonadism
primary hypogonadism
secondary hypogonadism

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 February 09, 2012