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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
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
2% testosterone gel
 Drug: Testosterone
2% gel
Other Name: Fortigel


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 ≥ 22 kg/m2 and < 35 kg/m2.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Liz Waldie Strakan Pharmaceuticals, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00522431     History of Changes
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

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