Clinical trial NCT01665599: A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
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: 2012-08-15
Enrollment: 180
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 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.


Eligibility criteria: Inclusion Criteria:

1. Males between 18-75 years of age
2. Two screening serum testosterone values less than 300 ng/dL
3. One or more symptoms of testosterone deficiency

Exclusion Criteria:

1. Previous use of the investigational product
2. Use of any investigational product within 30 days prior to screening and during the study
3. BMI less than 18 kg/m\^2 or more than 35 kg/m\^2
4. Prostatic mass(es)
5. Generalized skin irritation or skin disease
6. Lower urinary tract obstruction
7. Myocardial infarction or cerebrovascular accident in the last 6 months
8. Unstable angina or congestive heart failure
9. Thromboembolic disorders
10. Sleep apnea
11. Hyperparathyroidism or uncontrolled diabetes
12. Untreated moderate to severe depression
13. History of testicular, prostate, or breast cancer
14. HIV, Hepatitis B, or Hepatitis C positive
15. PSA more or equal to 3 ng/mL
16. Use of any medications that could be considered anabolic
17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
18. Chronic use of any drug of abuse
19. Involvement in a sport in which there is a screening for anabolic steroids
20. Not willing to use adequate contraception during the study
21. Partner is pregnant and/or breast feeding
22. Partner has a history of breast, uterine or ovarian cancer

Primary outcomes:
measure: The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
timeFrame: Day 90
Secondary outcomes:
measure: The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
timeFrame: Day 1
measure: Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT Measuring Tmax
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT Measuring Cmax
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT Measuring Cave
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT Measuring Cmin
timeFrame: Day 1; Day 90
measure: Pharmacokinetics of DHT Measuring Tmin
timeFrame: Day 1; Day 90
measure: Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
timeFrame: Day 91
measure: Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
timeFrame: Day 91
measure: Change From Baseline in the SF-12 Health Questionnaire
timeFrame: Day 91
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Cente
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: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
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: