Phase 3
N=321
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Male Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01403116 ↗Enrolled (actual)
321
Serious AEs
5.3%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL — 83.6; 79.2 percentage of partipants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral testosterone undecanoate (Drug); topical testosterone gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Clarus Therapeutics, Inc.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL |
83.6; 79.2 | — |
| SECONDARY % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 |
61 | — |
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.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT01403116). 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.