A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Completed · Phase 2
Conditions studied: Hypogonadal Males
In brief
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 999303, delivered using an applicator in comparison to hand application
Key facts
- Study ID
- NCT01464879
- Run by
- Ferring Pharmaceuticals
- People needed
- 20
- Starts
- 2011-12-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2017-09-13
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- AccuMed Research Associates — Garden City, New York, United States
Full record on ClinicalTrials.gov
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