A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01665599
First received: August 1, 2012
Last updated: April 10, 2013
Last verified: April 2013
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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:
Drug Information available for:
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
U.S. FDA Resources
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:
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300ng/dL
- One or more symptoms of testosterone deficiency
Exclusion Criteria:
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18kg/m2 or more than 35kg/m2
- Prostatic mass(es)
- Generalized skin irritation or skin disease
- Lower urinary tract obstruction
- Myocardial infarction or cerebrovascular accident in the last 6 months
- Unstable angina or congestive heart failure
- Tromboembolic disorders
- Sleep apnea
- Hyperparathyroidism or uncontrolled diabetes
- Untreated moderate to severe depression
- History of testicular, prostate, or breast cancer
- HIV, Hepatitis B, or Hepatitis C positive
- PSA more or equal to 3 ng/mL
- Use of any medications that could be considered anabolic
- Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
- Chronic use of any drug of abuse
- Involvement in a sport in which there is a screening for anabolic steroids
- Not willing to use adequate contraception during the study
- Partner is pregnant and/or breast feeding
- Partner has a history of breast, uterine or ovarian cancer
Contacts and Locations
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 10, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Hypogonadism Eunuchism 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 May 16, 2013