A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
NCT ID: NCT01665599
Last Updated: 2017-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2012-07-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Testosterone gel (FE 999303)
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
Testosterone gel (FE 999303)
Interventions
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Testosterone gel (FE 999303)
Eligibility Criteria
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Inclusion Criteria
2. Two screening serum testosterone values less than 300 ng/dL
3. One or more symptoms of testosterone deficiency
Exclusion Criteria
2. Use of any investigational product within 30 days prior to screening and during the study
3. BMI less than 18 kg/m\^2 or more than 35 kg/m\^2
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. Thromboembolic 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
18 Years
75 Years
MALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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000023
Identifier Type: -
Identifier Source: org_study_id