A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

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 999303, delivered using an applicator in comparison to hand application

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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