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NCT Number: NCT00522431

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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone

Drug

2% gel

Other names: Fortigel

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2007
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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