A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

Completed · Phase 3

Conditions studied: Adult Male Hypogonadism

In brief

This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Key facts

Study ID

NCT01665599

Run by

Ferring Pharmaceuticals

People needed

180

Starts

2012-07-01

Expected to finish

2013-05-01

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 screening serum testosterone values less than 300 ng/dL
• One or more symptoms of testosterone deficiency

You may not qualify if…

• Previous use of the investigational product
• Use of any investigational product within 30 days prior to screening and during the study
• BMI less than 18 kg/m\^2 or more than 35 kg/m\^2
• Prostatic mass(es)
• Generalized skin irritation or skin disease
• Lower urinary tract obstruction
• Myocardial infarction or cerebrovascular accident in the last 6 months
• Unstable angina or congestive heart failure
• Thromboembolic disorders
• Sleep apnea
• Hyperparathyroidism or uncontrolled diabetes
• Untreated moderate to severe depression
• History of testicular, prostate, or breast cancer
• HIV, Hepatitis B, or Hepatitis C positive
• PSA more or equal to 3 ng/mL
• Use of any medications that could be considered anabolic
• Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
• Chronic use of any drug of abuse
• Involvement in a sport in which there is a screening for anabolic steroids
• Not willing to use adequate contraception during the study
• Partner is pregnant and/or breast feeding
• Partner has a history of breast, uterine or ovarian cancer

Where it is running

• Medical Affiliated Research Cente — Huntsville, Alabama, United States
• California Professional Research — Newport Beach, California, United States
• San Diego Sexual Medicine — San Diego, California, United States
• Connecticut Clinical Research — Middlebury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Michigan Institute of Urology — Saint Clair Shores, Michigan, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Premier Urology Associates — Lawrenceville, New Jersey, United States
• University Urology — New York, New York, United States
• Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States
• PMG Research of Wilmington — Winston-Salem, North Carolina, United States
• Tristate Urologic Services — Cincinnati, Ohio, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Clinical Research Associates — Nashville, Tennessee, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• St. Joseph's Healthcare — London, Ontario, Canada
• Private Practice and Clinical Research — North Bay, Ontario, Canada

Full record on ClinicalTrials.gov

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