Efficacy, Pharmacokinetics and Safety of Testosterone

Completed · Phase 2

Conditions studied: Testicular Hypogonadism

In brief

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations \< 297 ng/dL.

Key facts

Study ID

NCT01370369

Run by

Ferring Pharmaceuticals

People needed

20

Starts

2011-05-01

Expected to finish

2011-07-01

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-65
• History of hypogonadism
• In good health based on medical history, physical examination and clinical laboratory tests
• Screening morning serum testosterone ≤ 297 ng/dL
• One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
• Body mass index (BMI) between 18 and 31

You may not qualify if…

• Prostate cancer
• Palpable prostatic mass(es)
• 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, finasteride, ketoconazole)
• Clinically significant anemia or renal dysfunction
• Hyperparathyroidism or uncontrolled diabetes
• Serum PSA Levels; ≥ 4ng/mL
• History of cardiovascular disease
• Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
• Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)

Where it is running

• AccuMed Research Associates — Garden City, New York, United States

Full record on ClinicalTrials.gov

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