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Huntsville, Alabama

  • Adult Male Hypogonadism

Purpose:

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.


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


NCT ID:

NCT01665599


Primary Contact:

Study Director
Clinical Development Support
Ferring Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Huntsville, Alabama
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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