A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

Adult Male Hypogonadism Clinical Trial

Official title:

A Multicenter Extension Trial to Evaluate the Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703741
• Other study ID #: 000077
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2012
• Last updated: September 19, 2017
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2017
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Male Hypogonadism
• Hypogonadism

Intervention

Drug:
• Testosterone Gel (FE 999093)

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	London	Ontario
Canada	Private Practice and Clinical Research	North Bay	Ontario
United States	South Florida Medical Research	Aventura	Florida
United States	Tristate Urologic Services	Cincinnati	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Premier Urology Associates	Lawrenceville	New Jersey
United States	Connecticut Clinical Research	Middlebury	Connecticut
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Clinical Research Associates	Nashville	Tennessee
United States	University Urology	New York	New York
United States	California Professional Research	Newport Beach	California
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Michigan Institute of Urology	Saint Clair Shores	Michigan
United States	San Diego Sexual Medicine	San Diego	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	PMG Research of Wilmington	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL	Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.	Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire	Data collected from the five domains of sexual functions were summarized by descriptive statistics.; The domains are: Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30); Orgasmic function (2 items, questions 9-10) (Score range: 0-10); Sexual desire (2 items, questions 11-12) (Score range: 2-10); Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15); Overall satisfaction (2 items, questions 13-14) (Score range: 2-10); A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain.	At Month 6
Secondary	Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire	In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions.; The data were presented using descriptive statistics.	At Month 6
Secondary	Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire	The MAF contains four sub-domains: Severity (2 items, questions 1-2) (Score range: 2-20); Distress (1 item, question 3) (Score range: 1-10); Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110); Timing (2 items, questions 15-16) (Score range: 5-20); A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.; To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).; The data were presented using descriptive statistics.	At Month 6
Secondary	Domain Scores for the Short Form-12 (SF-12) Questionnaire	Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item); MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item); The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.; The data were presented using descriptive statistics.	At Month 6
Secondary	Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL	The data were presented using descriptive statistics.	At Month 3
Secondary	Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL	The data were presented using descriptive statistics.	At Month 6
Secondary	Area Under the Concentration-time Curve (AUCt) for Total Testosterone and Dihydrotestosterone	Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone	Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone	Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone	Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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	Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone	Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.; The data were presented using descriptive statistics.	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)