A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
1 other identifier
interventional
180
2 countries
19
Brief Summary
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 (2%) delivered using an applicator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2012
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
September 20, 2017
CompletedOctober 26, 2017
September 1, 2017
9 months
August 1, 2012
July 3, 2017
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
The data were presented using descriptive statistics. No statistical analysis was performed.
Day 90
Secondary Outcomes (16)
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Day 1
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCÏ„)
Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 1; Day 90
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 1; Day 90
- +11 more secondary outcomes
Study Arms (1)
Testosterone gel (FE 999303)
EXPERIMENTALSubjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations. Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
Interventions
Eligibility Criteria
You may qualify if:
- Males between 18-75 years of age
- Two screening serum testosterone values less than 300 ng/dL
- One or more symptoms of testosterone deficiency
You may not qualify if:
- Previous use of the investigational product
- Use of any investigational product within 30 days prior to screening and during the study
- BMI less than 18 kg/m\^2 or more than 35 kg/m\^2
- 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
- Thromboembolic 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Medical Affiliated Research Cente
Huntsville, Alabama, United States
California Professional Research
Newport Beach, California, United States
San Diego Sexual Medicine
San Diego, California, United States
Connecticut Clinical Research
Middlebury, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Michigan Institute of Urology
Saint Clair Shores, Michigan, United States
Quality Clinical Research
Omaha, Nebraska, United States
Premier Urology Associates
Lawrenceville, New Jersey, United States
University Urology
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
PMG Research of Wilmington
Winston-Salem, North Carolina, United States
Tristate Urologic Services
Cincinnati, Ohio, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Clinical Research Associates
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
St. Joseph's Healthcare
London, Ontario, Canada
Private Practice and Clinical Research
North Bay, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 15, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
October 26, 2017
Results First Posted
September 20, 2017
Record last verified: 2017-09