Status:
COMPLETED
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Lead Sponsor:
Clarus Therapeutics, Inc.
Collaborating Sponsors:
PharmaNet
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Male Hypogonadism
Eligibility:
MALE
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
This was a randomized, open-label, 2-arm, active controlled, 12-month study of Oral TU that planned to enroll ≈ 300 hypogonadal men (≈ 150/group) at multiple study sites. Incorporated in the design wa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT01403116
Start Date
July 1 2011
End Date
September 1 2013
Last Update
August 14 2018
Active Locations (30)
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1
Alabama Clinical Therapeutics, Inc.
Birmingham, Alabama, United States, 35235
2
Alabama Internal Medicine, PC
Birmingham, Alabama, United States, 35235
3
Alabama Clinical Therapeutics
Calera, Alabama, United States, 35040
4
Medical Affliated Research Center, Inc.
Huntsville, Alabama, United States, 35801