Clinical trial NCT02149264: A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Male Hypogonadism
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Males between 18-75 years of age
* Two fasting serum testosterone levels \<300 ng/dL

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
timeFrame: At Day 90
Secondary outcomes:
measure: The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
timeFrame: At 14, 35 and 56
measure: Change From Baseline in International Index of Erectile Function (IIEF) Score
timeFrame: At Days 35 and 90
measure: Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
timeFrame: At Days 35 and 90
measure: Change From Baseline in Short Form-12 Health Survey (SF-12) Score
timeFrame: At Days 35 and 90
measure: Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
timeFrame: 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
measure: Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
timeFrame: 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
measure: Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
timeFrame: 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
measure: Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
timeFrame: 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
measure: Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
timeFrame: 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
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigational site
state: Alabama
city: Huntsville
country: United States
facility: Investigational site
state: Alabama
city: Newport Beach
country: United States
facility: Investigational site
state: California
city: Denver
country: United States
facility: Investigational site
state: Colorado
city: New Haven
country: United States
facility: Investigational site
state: Connecticut
city: Aventura
country: United States
facility: Investigational site
state: Florida
city: Clearwater
country: United States
facility: Investigational site
state: Florida
city: Mishawaka
country: United States
facility: Investigational site
state: Indiana
city: Watertown
country: United States
facility: Investigational site
state: Massachusetts
city: Troy
country: United States
facility: Investigational site
state: Michigan
city: Edison
country: United States
facility: Investigational site
state: New Jersey
city: Lawrence Township
country: United States
facility: Investigational site
state: New Jersey
city: Garden City
country: United States
facility: Investigational site
state: New York
city: New York
country: United States
facility: Investigational site
state: New York
city: Poughkeepsie
country: United States
facility: Investigational site
state: New York
city: Purchase
country: United States
facility: Investigational site
state: New York
city: Bala-Cynwyd
country: United States
facility: Investigational site
state: Pennsylvania
city: Warwick
country: United States
facility: Investigational site
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Investigational site
state: South Carolina
city: Nashville
country: United States
facility: Investigational site
state: Tennessee
city: Webster
country: United States
facility: Investigational site
state: Texas
city: Norfolk
country: United States
facility: Investigational site
state: Virginia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: