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
Summary
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/dLPharmacokinetics 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
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
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