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

Tracking Information

First Received Date ^ICMJE

August 28, 2007

Last Updated Date

May 6, 2009

Start Date ^ICMJE

August 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00522431 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase III

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypogonadism

Intervention ^ICMJE

Drug: Testosterone

2% gel

Other Name: Fortigel

Study Arms

Experimental: 1

2% testosterone gel

Intervention: Drug: Testosterone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

149

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00522431

Other Study ID Numbers ^ICMJE

FOR01C

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Prostrakan Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Liz Waldie

Strakan Pharmaceuticals, Inc.

Information Provided By

Prostrakan Pharmaceuticals

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP