A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
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ClinicalTrials.gov Identifier: NCT00522431 |
Recruitment Status :
Completed
First Posted : August 29, 2007
Results First Posted : March 7, 2014
Last Update Posted : October 5, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Hypogonadism | Drug: Testosterone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 149 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
2% testosterone gel
|
Drug: Testosterone
2% gel
Other Name: Fortigel |
- 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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522431
Study Director: | Liz Waldie | Strakan Pharmaceuticals, Inc. |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00522431 |
Other Study ID Numbers: |
FOR01C |
First Posted: | August 29, 2007 Key Record Dates |
Results First Posted: | March 7, 2014 |
Last Update Posted: | October 5, 2017 |
Last Verified: | September 2017 |
Hypogonadism |
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |