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

NCT00522431 | Completed Phase 3 Results

• 1 other identifier: FOR01C
• Study Type: interventional
• Target: 149
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypogonadism

Keywords

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

2% testosterone gel

Drug: Testosterone

Interventions

Testosterone DRUG

2% gel

Also known as: Fortigel

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Liz Waldie

  Strakan Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 5, 2017
• Results First Posted: March 7, 2014

Record last verified: 2017-09