Status:
COMPLETED
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Hypogonadal Males
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999...
Eligibility Criteria
Inclusion
- Ages 18-75
- History of hypogonadism
- In good health based on medical history, physical examination, and clinical laboratory tests
- Serum testosterone deficiency
- One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
- Body mass index (BMI) between 18 and 35 kg/m\^2
- All screening lab tests within 20% of the normal range (exceptions are liver function tests)
- HIV, Hepatitis B and C negative
Exclusion
- Previous use of FE 999303
- Prostate cancer
- Breast carcinoma, patient or partner
- Palpable prostatic mass(es)
- Serum PSA levels ≥3 ng/dL
- Chronic use of any drug of abuse
- Lower urinary tract obstruction
- Clinically significant anemia or renal dysfunction
- Cardiovascular disease
- Hyperparathyroidism or uncontrolled diabetes
- Generalized skin irritation or significant skin disease
- Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
- Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
- Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
- Sleep apnea
- Untreated depression
- Subject with a partner who is pregnant or will not use contraception
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01464879
Start Date
December 1 2011
End Date
May 1 2012
Last Update
September 13 2017
Active Locations (1)
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1
AccuMed Research Associates
Garden City, New York, United States