A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01703741
First received: October 4, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.


Condition Intervention Phase
Male Hypogonadism
Drug: Testosterone Gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of subjects with a serum total testosterone level of 1500-1799, 1800-2499, or above 2500 ng/dL [ Time Frame: Between Month 3 and Month 6 ] [ Designated as safety issue: Yes ]
    Measurement of total testosterone level occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.


Secondary Outcome Measures:
  • Percentage of subjects with a serum total testosterone level greater than 300 ng/dL [ Time Frame: Between Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Measurement of total testosterone level occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

  • Domain scores for the IIEF questionnaire [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects with a negative ADAM questionnaire [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Domain scores for the MAF questionnaire [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Domain scores for the SF-12 questionnaire [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Percentage of subjects with a serum total testosterone level of 1500-1799, 1800-2499, or above 2500 ng/dL [ Time Frame: Month 3 ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with a serum total testosterone level of 1500-1799, 1800-2499, or above 2500 ng/dL [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of total testosterone measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2 [ Time Frame: Between Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Measurement of total testosterone level occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.

  • Pharmacokinetics of DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2 [ Time Frame: Between Month 3 and Month 6 ] [ Designated as safety issue: No ]
    Measurement of total testosterone level occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.


Enrollment: 145
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A.
Testosterone Gel delivered using an applicator
Drug: Testosterone Gel
Testosterone Gel delivered using an applicator

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of the Phase 3 protocol (NCT01665599)

Exclusion Criteria:

  • Use of another investigational product
  • Use of any medications that could be considered anabolic or interfere with androgen metabolism
  • Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
  • Use of another testosterone product
  • Chronic use of any drug of abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703741

Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States
United States, California
California Professional Research
Newport Beach, California, United States
San Diego Sexual Medicine
San Diego, California, United States
United States, Connecticut
Connecticut Clinical Research
Middlebury, Connecticut, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
United States, Michigan
Michigan Institute of Urology
St. Clair Shores, Michigan, United States
United States, New Jersey
Premier Urology Associates
Lawrenceville, New Jersey, United States
United States, New York
University Urology
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
United States, North Carolina
PMG Research of Wilmington
Winston-Salem, North Carolina, United States
United States, Ohio
Tristate Urologic Services
Cincinnati, Ohio, United States
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States
United States, Texas
Urology Clinics of North Texas
Dallas, Texas, United States
Canada, Ontario
St. Joseph's Healthcare
London, Ontario, Canada
Private Practice and Clinical Research
North Bay, Ontario, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01703741     History of Changes
Other Study ID Numbers: 000077
Study First Received: October 4, 2012
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 16, 2014