A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
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...
Brief Summary
Official Title: “An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: Testosterone
- 2% gel
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 2% testosterone gel
Outcome Measures for this Clinical Trial
Primary 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
- Time Frame: 90 days
Secondary 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
- Time Frame: 90 days
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Prostrakan Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Liz Waldie Study Director Strakan Pharmaceuticals, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00522431
Study ID Number: FOR01C
ClinicalTrials.gov Identifier: NCT00522431
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00522431
