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

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Male Hypogonadism

Intervention: Testosterone gel (FE 999303) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals


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 delivered using an applicator.

Clinical Details

Official title: A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percentage of subjects on day 90 whose Cavg (0-24) serum total testosterone levels are between 300 and 1050 ng/dL

Secondary outcome:

The percentage of subjects on Day 1 whose serum Cavg (0-24) serum total testosterone levels are between 300 and 1050 ng/dL

Pharmacokinetics of total testosterone measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2

Change from baseline in the international index of erectile dysfunction (IIEF)questionnaire

Pharmacokinetics of DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2

Change from baseline in the multidimensional assessment of fatigue (MAF)questionnaire

Change from baseline in the SF-12 health questionnaire


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


Inclusion Criteria: 1. Males between 18-75 years of age 2. Two screening serum testosterone values less than 300ng/dL 3. One or more symptoms of testosterone deficiency Exclusion Criteria: 1. Previous use of the investigational product 2. Use of any investigational product within 30 days prior to screening and during the study 3. BMI less than 18kg/m2 or more than 35kg/m2 4. Prostatic mass(es) 5. Generalized skin irritation or skin disease 6. Lower urinary tract obstruction 7. Myocardial infarction or cerebrovascular accident in the last 6 months 8. Unstable angina or congestive heart failure 9. Tromboembolic disorders 10. Sleep apnea 11. Hyperparathyroidism or uncontrolled diabetes 12. Untreated moderate to severe depression 13. History of testicular, prostate, or breast cancer 14. HIV, Hepatitis B, or Hepatitis C positive 15. PSA more or equal to 3 ng/mL 16. Use of any medications that could be considered anabolic 17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone 18. Chronic use of any drug of abuse 19. Involvement in a sport in which there is a screening for anabolic steroids 20. Not willing to use adequate contraception during the study 21. Partner is pregnant and/or breast feeding 22. Partner has a history of breast, uterine or ovarian cancer

Locations and Contacts

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, St. 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

St. Joseph's Healthcare, London, Ontario, Canada

Private Practice and Clinical Research, North Bay, Ontario, Canada

Omega Medical Research, Warwick, Rhode Island, United States

Coastal Carolina Research Center, Mount 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

Additional Information

Starting date: August 2012
Last updated: April 8, 2014

Page last updated: August 23, 2015

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