Phase 3
Completed N=149
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Source: ClinicalTrials.gov NCT00522431 ↗Enrolled (actual)
149
Serious AEs
3.4%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 — 77.5 percentage of participants
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.
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 | — |
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.
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. Informational only — not medical advice.