A Phase 3 interventional study of Doxazosin and Finasteride in Prostatic Hyperplasia and Prostatic Hypertrophy, Benign, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 17 sites in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-28.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Treatment
The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).
MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 3,407 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Doxazosin and Finasteride placebos
Drug: Doxazosin placebo · Drug: Finasteride placebo
Doxazosin and Finasteride placebo
Drug: Doxazosin · Drug: Finasteride placebo
Doxazosin placebo and Finasteride
Drug: Finasteride · Drug: Doxazosin placebo
Doxazosin and Finasteride
Drug: Doxazosin · Drug: Doxazosin placebo
Plan to share: Yes — Data and specimens will be submitted to the NIDDK Central Repository
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)