At a glance
ClinicalIndex Comparison Record- ✓Male age 18-65 years with hypogonadism defined by two AM total testosterone values <300 ng/dL on separate days ~7 days apart
- ✓Naive to androgen replacement therapy or adequately washed out from prior androgen therapies; willing to stop current T treatment and remain off all T except study drug
- ✓If on replacement therapy for hypopituitarism or multiple endocrine deficiencies, must be on stable doses of thyroid and adrenal replacement hormones for at least 14 days before screening
- ✓Adequate venous access
- ✕Recent cardiovascular events within 2 years: stroke, TIA, acute coronary event, angina, or stent placement
- ✕Uncontrolled or poorly controlled heart disease, including hypertension (mean sBP >150 mm Hg or dBP >90 mm Hg), congestive heart failure, or coronary heart disease
- ✕Untreated severe obstructive sleep apnea
- ✕Abnormal liver, kidney, or hematologic function: serum transaminases >2× ULN, bilirubin >1.5× ULN, creatinine >1.5× ULN, or hematocrit <35% or >48%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
In Brief
A Phase 3 clinical trial evaluating Oral Testosterone Undecanoate and Axiron Testosterone Topical Solution for Hypogonadism. Completed, enrolled 222 participants across 1 site.
Detailed Summary
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Study Details
Timeline
Interventions
Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.