Safety and Efficacy Trial of Testosterone Undecanoate
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
1 other identifier
interventional
144
1 country
27
Brief Summary
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2013
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
September 21, 2017
CompletedDecember 12, 2017
November 1, 2017
6 months
January 8, 2013
August 22, 2017
November 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Secondary Outcomes (1)
Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Study Arms (1)
Oral testosterone undecanoate
EXPERIMENTALInterventions
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
Eligibility Criteria
You may qualify if:
- Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
You may not qualify if:
- Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
- Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
- Untreated, severe 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 mg/dL
- BMI \> or equal to 38
- Stable doses of lipid-lowering medication for less than three months
- Stable doses of oral medication for diabetes for less than two months
- Abnormal prostate digital rectal examination \[palpable nodule(s)\], elevated PSA (serum PSA \>3.9 ng/mL), IPSS score \> or equal to 19 points, and /or history of prostate cancer.
- History of breast cancer
- Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
- Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
- Known history of abuse of alcohol or any drug substance with 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clarus Therapeutics, Inc.lead
- inVentiv Health Clinicalcollaborator
Study Sites (27)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Alabama Internal Medicine, PC
Birmingham, Alabama, 35235, United States
Medical Affliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Precision Trials/Valley Urologic Associates
Glendale, Arizona, 85308, United States
Premier Clinical Research Center
Phoenix, Arizona, 85027, United States
Precision Trials/Valley Urologic Associates
Phoenix, Arizona, 85032, United States
Quality of LIfe Medical and Research Center
Tucson, Arizona, 85712, United States
SC Clinical Research, Inc.
Garden Grove, California, 92844, United States
South ORange County Endocrinology
Laguna Hill, California, 92653, United States
Tower Urology, Tower Research Institute
Los Angeles, California, 90048, United States
San Diego Sexual Medicine
San Diego, California, 92120, United States
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Conneticut Clinical Research Center
Middlebury, Connecticut, 06762, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223, United States
University Urology Associates
New York, New York, 10016, United States
Sunstone Medical Research
Medford, Oregon, 97504, United States
Unrologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Research Across America
Carrollton, Texas, 75010, United States
Research Across America
Dallas, Texas, 75234, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Potenium Clinical Research, LLC
Hurst, Texas, 76053, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Rainer Clinical Research Center, Inc.
Renton, Washington, 98057, United States
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP Clinical and Medical Affairs
- Organization
- Clarus Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Swerdloff, MD
Los Andgeles Biomedical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2013
First Posted
January 10, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 12, 2017
Results First Posted
September 21, 2017
Record last verified: 2017-11