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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00522431

First Posted: August 29, 2007

Last Update Posted: October 5, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Endo Pharmaceuticals

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:	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

Resource links provided by NLM:

Drug Information available for: Testosterone

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

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:

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


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

Information from the National Library of Medicine

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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

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


Responsible Party:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00522431 History of Changes
Other Study ID Numbers:	FOR01C
First Submitted:	August 28, 2007
First Posted:	August 29, 2007
Results First Submitted:	January 24, 2014
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

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