A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

Adult Male Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665599
• Other study ID #: 000023
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2012
• Last updated: September 25, 2017
• Start date: July 2012
• Est. completion date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Male Hypogonadism
• Hypogonadism

Intervention

Drug:
• Testosterone gel (FE 999303)

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 Cente	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	Quality Clinical Research	Omaha	Nebraska
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	The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL	The data were presented using descriptive statistics. No statistical analysis was performed.	Day 90
Secondary	The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL	The data were presented using descriptive statistics. No statistical analysis was performed.	Day 1
Secondary	Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCt)	A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)	A validated LC/MS/MS method was used to determine the levels of total testosterone.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCt	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT Measuring Tmax	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT Measuring Cmax	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT Measuring Cave	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT Measuring Cmin	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Pharmacokinetics of DHT Measuring Tmin	A validated LC/MS/MS method was used to determine the levels of DHT.	Day 1; Day 90
Secondary	Change From Baseline in the International Index of Erectile Dysfunction (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 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.	Day 91
Secondary	Change From Baseline in the Multidimensional Assessment 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 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.	Day 91
Secondary	Change From Baseline in the SF-12 Health 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 standard deviation 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.	Day 91