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

Phase 3

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Testosterone

• Registration Number: NCT00522431
• Lead Sponsor: Endo Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-29
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2014-01-24
• Results First Submitted QC: 2014-01-24
• Results First Posted: 2014-03-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 149

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Testosterone	2% testosterone gel

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90	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

Name	Time	Method
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90	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