Testosterone Treatment for Hypogonadal Men

This study has been completed.

First Received: February 8, 2007 Last Updated: November 29, 2007 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00433199

Purpose

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone Gel 1.62%	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of 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 Solvay Pharmaceuticals:

Primary Outcome Measures:

Percentage of subjects with TT within the normal range

Secondary Outcome Measures:

Evaluate safety for up to one year of use, TNF-alpha, IL-6, IL-10, hs-CRP, MMP-9, HDL2, HDL3, VCAM, D-Dimer, Fibrinogen, Bone-specific alkaline phosphatase, Type 1 cross-linked C telopeptide, SF-36 and % free PSA

Estimated Enrollment:	224
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Low T males 18 - 80 years of age

Exclusion Criteria:

Normal T levels
Elevated PSA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433199

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	S176.3.104
Study First Received:	February 8, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00433199 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Hypogonadism
Testosterone Deficiency

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010