A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

Completed · Phase 3

Conditions studied: Adult Male Hypogonadism

In brief

This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

Key facts

Study ID

NCT02149264

Run by

Ferring Pharmaceuticals

People needed

160

Starts

2014-07-01

Expected to finish

2015-06-01

Last updated by the study team

2017-10-26

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males between 18-75 years of age
• Two fasting serum testosterone levels <300 ng/dL

You may not qualify if…

• Previous use of the study drug
• History of prostate or breast cancer
• Prostate-Specific Antigen (PSA) ≥3 ng/mL
• Subject is sexually active and not willing to use adequate contraception

Where it is running

• Investigational site — Anniston, Alabama, United States
• Investigational site — Huntsville, Alabama, United States
• Investigational site — Newport Beach, California, United States
• Investigational site — Denver, Colorado, United States
• Investigational site — New Haven, Connecticut, United States
• Investigational site — Aventura, Florida, United States
• Investigational site — Clearwater, Florida, United States
• Investigational site — Mishawaka, Indiana, United States
• Investigational site — Watertown, Massachusetts, United States
• Investigational site — Troy, Michigan, United States
• Investigational site — Edison, New Jersey, United States
• Investigational site — Lawrence, New Jersey, United States
• Investigational site — Garden City, New York, United States
• Investigational site — New York, New York, United States
• Investigational site — Poughkeepsie, New York, United States
• Investigational site — Purchase, New York, United States
• Investigational site — Bala-Cynwyd, Pennsylvania, United States
• Investigational site — Warwick, Rhode Island, United States
• Investigational site — Mt. Pleasant, South Carolina, United States
• Investigational site — Nashville, Tennessee, United States
• Investigational site — Webster, Texas, United States
• Investigational site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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