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A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
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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 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males |
- Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 ]Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
- Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 ]Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL
| 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 |
|---|---|
|
Experimental: 1
2% testosterone gel
|
Drug: Testosterone
2% gel
Other Name: Fortigel
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 ≥ 22 kg/m2 and < 35 kg/m2.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00522431
| Study Director: | Liz Waldie | Strakan Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00522431 History of Changes |
| Other Study ID Numbers: |
FOR01C |
| Study First Received: | August 28, 2007 |
| Results First Received: | January 24, 2014 |
| Last Updated: | April 3, 2017 |
Keywords provided by Endo Pharmaceuticals:
|
Hypogonadism |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |
ClinicalTrials.gov processed this record on July 19, 2017