Phase 3 N=149 Treatment

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

Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT00522431 ↗

Enrolled (actual)

149

Serious AEs

3.4%

Results posted

Mar 2014

Primary outcome: Primary: Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 — 77.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Testosterone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Endo Pharmaceuticals
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90	77.5	—
SECONDARY Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90	94.6; 1.6; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00522431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.