They will be followed very
Tests and all medications needed as part of the study will be provided at no charge to the participant. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with BPH from getting worse. DURATION Participants will continue on study treatment until they meet protocol defined reason for treatment discontinuation or complete weeks of followup at the assigned treatment. SAMPLE SIZE participants randomized in allocation to Serenoa repens or placebo. Arms 2Other NamesSerenoa repens saw palmettoAny prior invasive intervention for BPH. Phytotherapy for BPH or 5alpha reductase inhibitor within months. Alpha blocker within one month.
During the study, men will not know which of the two treatments they are assigned to. Participants will be randomized to one of the treatment armsSerenoa repens mg once daily for weeks. Placebo for weeks. Men in the CAMUS trial will be studied over weeks.
DURATION Participants will continue on study treatment until they meet protocol defined reason for treatment discontinuation or complete weeks of followup at the assigned treatment. SAMPLE SIZE participants randomized in allocation to Serenoa repens or placebo. Arms 2Other NamesSerenoa repens saw palmetto Drug Placebo matching placebo interventionDrug Saw Palmetto Drug Saw PalmettoREGIMEN Participants will be responsible for all other costs not associated with the study tests and medications. Tests and all medications needed as part of the study will be provided at no charge to the participant.
All information on study participants will be held in the strictest confidence and no one would have access to patient information other than the required authorized health care and research personnel. Drug Saw Palmetto Drug Saw PalmettoREGIMEN Participants will be randomized to one of the treatment armsSerenoa repens mg once daily for weeks. Placebo for weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with BPH from getting worse.
potential participant is considered cured or not. Unable to follow protocol directions due to organic brain or psychiatric disease. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol. Any serious medical condition likely to impede successful completion of the study.. They will be followed very closely by study team every weeks to see how they are doing. DURATION Participants will continue on study treatment until they meet protocol defined reason for treatment discontinuation or complete weeks of followup at the assigned treatment.
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