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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00522431
First received: August 28, 2007
Last updated: January 24, 2014
Last verified: January 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
Genders 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 ³ 22 kg/m2 and < 35 kg/m2.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522431

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

No publications provided

Responsible Party: Prostrakan 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: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Prostrakan 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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 14, 2014