A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone - Full Text View

Sponsor:	Prostrakan Pharmaceuticals
Information provided by:	Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00522431

Purpose

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

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 Prostrakan Pharmaceuticals:

Primary Outcome Measures:

The primary objective of this study is to replace testosterone in hypogonadal males so that the time averaged serum total testosterone (Cavg) on day 90 lies within specific limits within a pre-specified percentage of patients. [ Time Frame: 90 days ]

Secondary Outcome Measures:

To replace testosterone in hypogonadal males so that the maximum serum total testosterone (Cmax) on day 90 lies within specific limits. To determine the safety of Fortigel testosterone gel 2.0% in hypogonadal males. [ Time Frame: 90 days ]

Enrollment:	149
Study Start Date:	August 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2% testosterone gel	Drug: Testosterone 2% gel

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:
- Single serum total testosterone concentration < 250 ng/dL, or
- Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).
Has a BMI ³ 22 kg/m2 and < 35 kg/m2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522431

Sponsors and Collaborators

Prostrakan Pharmaceuticals

Investigators

Study Director:

Liz Waldie

Strakan Pharmaceuticals, Inc.

More Information

No publications provided

Study ID Numbers:	FOR01C
Study First Received:	August 28, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00522431 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Prostrakan Pharmaceuticals:

Hypogonadism

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 November 20, 2009