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A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

This study has been completed.
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals Identifier:
First received: August 28, 2007
Last updated: January 24, 2014
Last verified: January 2014

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
Drug: Testosterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

Resource links provided by NLM:

Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome 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 ]

Secondary Outcome 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 ]

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


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 ³ 22 kg/m2 and < 35 kg/m2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00522431

Sponsors and Collaborators
Prostrakan Pharmaceuticals
Study Director: Liz Waldie Strakan Pharmaceuticals, Inc.
  More Information

Responsible Party: Prostrakan Pharmaceuticals Identifier: NCT00522431     History of Changes
Other Study ID Numbers: FOR01C 
Study First Received: August 28, 2007
Results First Received: January 24, 2014
Last Updated: January 24, 2014

Keywords provided by Prostrakan Pharmaceuticals:

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on February 20, 2017