Phase 3
N=222
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02722278 ↗Enrolled (actual)
222
Serious AEs
0.9%
Results posted
Feb 2018
Primary outcome: Primary: Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 — 145; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral Testosterone Undecanoate (Drug); Axiron Testosterone Topical Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Clarus Therapeutics, Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 |
145; 48 | — |
Summary
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Eligibility Criteria
Inclusion Criteria
- Man 18 to 65 years of age, inclusive, with hypogonadism as defined by 2 AM total T values of 150 mm Hg and/or diastolic blood pressure (dBP) > 90 mm Hg at screening.
- Recent (within 2 years) history of angina or stent (coronary or carotid) placement.
- Untreated, severe obstructive sleep apnea.
- Clinically significant abnormal laboratory values (serum transaminases > 2 × ULN, serum bilirubin > 1.5 × ULN and serum creatinine > 1.5 × ULN).
- Hematocrit (HCT) value of 48%.
- Has a history of polycythemia, either idiopathic or associated with testosterone replacement therapy (TRT).
- Glycosylated hemoglobin (A1C) > 8.5%.
- BMI ≥ 38 kg/m2.
- If receiving the following medications:
- Has been on stable doses of lipid-lowering medication for 4.0 ng/mL), International Prostate Symptom Score (I-PSS) > 19 points at screening, and/or history of, or current or suspected, prostate cancer.
- History of, or current or suspected, breast cancer.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation within the previous 2 years.
- Use of dietary supplements such as saw palmetto or phytoestrogens and any dietary supplements that may increase total T, such as androstenedione or dehydroepiandrosterone within the previous 4 weeks.
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors and bile acid-binding resins.
- Inability to refrain from smoking during the confinement periods as required by the individual study center.
- History of alcohol abuse or any drug substance within the previous 2 years.
- Poor compliance or unlikely to keep clinic appointments.
- Has received any drug as part of another research study within 30 days of initial dose administration in this study.
- Donated blood (≥ 500 mL) within the 12-week period before the initial study dose.
- Currently uses antiandrogens, 5-alpha-reductase inhibitors, estrogens, potent oral CYP3A4 inducers, potent CYP3A4 inhibitors, or long acting opioid analgesics.
- Unwilling or unable to follow the dietary guidelines for this study, related to taking oral TU with meals that contain approximately 20 to 40 g of fat
Data sourced from ClinicalTrials.gov (NCT02722278). 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.