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

History of Changes

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:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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 (Adult, Senior)
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

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 ClinicalTrials.gov identifier: NCT00522431

Sponsors and Collaborators

Prostrakan Pharmaceuticals

Investigators


Study Director:	Liz Waldie	Strakan Pharmaceuticals, Inc.

More Information


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 Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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