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

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522431
• Other study ID #: FOR01C
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2007
• Last updated: September 7, 2017
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2017
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone
2% gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90	Percentage of participants with Cavg0-24h =300-=1140 ng/dL	0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Secondary	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90	Percentage of participants with Cmax =1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL	0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90