A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
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, open-label, non-randomized, clinical trial to evaluate the efficacy and
safety of FE 999303 (Testosterone Gel) in adult hypogonadal males.
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 whose average concentration (Cave(0-24)) serum total testosterone levels are ≥300 and ≤1050 ng/dL
Secondary outcome: The percentage of subjects whose Cave(0-24) serum total testosterone levels are ≥300 and ≤1050 ng/dLChange from baseline in International Index of Erectile Function (IIEF) score Change from baseline in Multidimensional Assessment of Fatigue (MAF) score Change from baseline in Short Form-12 Health Survey (SF-12) score Average concentration (Cave) for total testosterone and dihydrotestosterone Area under the concentration-time curve (AUCτ) for total testosterone and dihydrotestosterone Time at which the maximum concentration occurs (Tmax) for total testosterone and dihydrotestosterone Maximum concentration observed (Cmax) for total testosterone and dihydrotestosterone Minimum concentration observed (Cmin) for total testosterone and dihydrotestosterone
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Males between 18-75 years of age
- Two serum testosterone levels <300 ng/dL
Exclusion Criteria:
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/dL
- Subject is sexually active and not willing to use adequate contraception
Locations and Contacts
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 Township, New Jersey, 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
Additional Information
Starting date: July 2014
Last updated: June 25, 2015
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