Clinical trial NCT01703741: A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Official title: A Multicenter Extension Trial to Evaluate the 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: 2012-10-10
Enrollment: 145
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 multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.


Eligibility criteria: Inclusion Criteria:

* Completion of the Phase 3 protocol (NCT01665599)

Exclusion Criteria:

* Use of another investigational product
* Use of any medications that could be considered anabolic or interfere with androgen metabolism
* Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
* Use of another testosterone product
* Chronic use of any drug of abuse

Primary outcomes:
measure: Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Secondary outcomes:
measure: Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
measure: Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire
timeFrame: At Month 6
measure: Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire
timeFrame: At Month 6
measure: Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire
timeFrame: At Month 6
measure: Domain Scores for the Short Form-12 (SF-12) Questionnaire
timeFrame: At Month 6
measure: Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
timeFrame: At Month 3
measure: Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL
timeFrame: At Month 6
measure: Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
measure: Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
measure: Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
measure: Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
measure: Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
timeFrame: Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Newport Beach
country: United States
facility: California Professional Research
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Middlebury
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Saint Clair Shores
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Lawrenceville
country: United States
facility: Premier Urology Associates
state: New Jersey
city: New York
country: United States
facility: University Urology
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Winston-Salem
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Cincinnati
country: United States
facility: Tristate Urologic Services
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: London
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: North Bay
country: Canada
facility: Private Practice and Clinical Research
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: