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



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:10/28/2017
Start Date:July 2012
End Date:May 2013

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A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

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.


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
We found this trial at
18
sites
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Aventura, Florida 33180
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Cincinnati, Ohio
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Dallas, Texas 75231
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Huntsville, Alabama
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Lawrenceville, New Jersey
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London, Ontario
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Middlebury, Connecticut 06762
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Mount Pleasant, South Carolina 29464
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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Nashville, Tennessee 37203
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New York, New York 10016
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Newport Beach, California 92660
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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20952 East Twelve Mile Road
Saint Clair Shores, Michigan 48081
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San Diego, California 92120
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Winston-Salem, North Carolina
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