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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/dL

Change 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

Page last updated: August 23, 2015

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