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
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