Phase 3
N=144
Safety and Efficacy Trial of Testosterone Undecanoate
Male Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01765179 ↗Enrolled (actual)
144
Serious AEs
1.4%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL — 87 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral testosterone undecanoate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Clarus Therapeutics, Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL |
87 | — |
| SECONDARY Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population |
95; 10; 7; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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 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
- Blood donation within the 12 week period before initial dose administration in this study
Data sourced from ClinicalTrials.gov (NCT01765179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.