At a glance
ClinicalIndex Comparison Record- ✓Age 50 years or older
- ✓Low testosterone: total T <280 ng/dL on one occasion OR ≤300 ng/dL on average of two occasions
- ✓Prostate volume ≥30 cc by MRI
- ✓PSA 1.5–10 ng/mL; if >4.0 ng/mL, negative prostate biopsy required
- ✕History of prostate or breast cancer
- ✕Prior invasive BPH therapy
- ✕Acute urinary retention in the 3 months prior to screening
- ✕Previous treatment with 5-alpha reductase inhibitor (finasteride or dutasteride)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Testosterone Replacement and Dutasteride Effectiveness (TRADE)
In Brief
A Phase 4 clinical trial evaluating Dutasteride, Testosterone gel, and 1 other intervention for Hypogonadism and Benign Prostatic Hyperplasia. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).
Study Details
Timeline
Interventions
Dutasteride 0.5 mg orally daily
Testosterone gel 7.5 g daily topical
placebo dutasteride orally daily