Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarus Therapeutics, Inc.
• Collaborators: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; PharmaNet
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

• Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness

• Recent history of stroke, not including transient ischemic attack

• Untreated, sever obstructive sleep apnea.

• Hematocrit <35% or >48

• Serum transaminases >2 times upper limit of normal, serum bilirubin > 2.0 mg/dL and serum creatinine > 2.0 mgk/dL

• BMI > or equal to 36

• Stable doses of lipid-lowering medication for less than 3 months

• Stable doses of oral medication for diabetes for less than 2 months

• Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or equal to 19 points.

• History of breast cancer

• Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks

• Known malabsorption syndrome and/or current treatment with oral lipase inhibitors

• History of abuse of alcohol or any drug substance within the previous 2 years

• Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics

• Receipt of any drug as part of a research study within 30 days of initial dose administration in this study.

• Blood donation within the 12 week period before the initial study dose.