A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
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
160
1 country
22
Brief 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.
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 2014
Shorter than P25 for phase_3
22 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
First Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 28, 2017
CompletedOctober 26, 2017
September 1, 2017
10 months
May 19, 2014
June 29, 2017
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
At Day 90
Secondary Outcomes (9)
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
At 14, 35 and 56
Change From Baseline in International Index of Erectile Function (IIEF) Score
At Days 35 and 90
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
At Days 35 and 90
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
At Days 35 and 90
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90
- +4 more secondary outcomes
Study Arms (1)
Testosterone gel (FE 999303)
EXPERIMENTALSubjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
Interventions
Eligibility Criteria
You may qualify if:
- Males between 18-75 years of age
- Two fasting serum testosterone levels \<300 ng/dL
You may not qualify if:
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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, New Jersey, United States
Investigational site
Garden City, New York, 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
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
May 19, 2014
First Posted
May 29, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
October 26, 2017
Results First Posted
July 28, 2017
Record last verified: 2017-09