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A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Information source: Prostrakan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: Testosterone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Prostrakan Pharmaceuticals

Official(s) and/or principal investigator(s):
Liz Waldie, Study Director, Affiliation: Strakan Pharmaceuticals, Inc.

Summary

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.

Clinical Details

Official title: An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.

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.

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21287, United States
Additional Information

Starting date: August 2007
Ending date: June 2009
Last updated: January 15, 2008

Page last updated: June 20, 2008

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