A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01665599
First received: August 1, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Adult Male Hypogonadism
Drug: Testosterone gel (FE 999303)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • The percentage of subjects on day 90 whose Cavg (0-24) serum total testosterone levels are between 300 and 1050 ng/dL [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of subjects on Day 1 whose serum Cavg (0-24) serum total testosterone levels are between 300 and 1050 ng/dL [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of total testosterone measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2 [ Time Frame: Day 1; Day 90 ] [ Designated as safety issue: No ]
  • Change from baseline in the international index of erectile dysfunction (IIEF)questionnaire [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cave, Cmin, and T1/2 [ Time Frame: Day 1; Day 90 ] [ Designated as safety issue: No ]
  • Change from baseline in the multidimensional assessment of fatigue (MAF)questionnaire [ Time Frame: Day 91 ] [ Designated as safety issue: No ]
  • Change from baseline in the SF-12 health questionnaire [ Time Frame: Day 91 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: August 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone gel (FE 999303) Drug: Testosterone gel (FE 999303)
The testosterone gel is 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:

  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
  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: NCT01665599

Locations
United States, Alabama
Medical Affiliated Research Cente
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, Nebraska
Quality Clinical Research
Omaha, Nebraska, 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: NCT01665599     History of Changes
Other Study ID Numbers: 000023
Study First Received: August 1, 2012
Last Updated: April 8, 2014
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 18, 2014