Clinical trial NCT00603304
Conditions: Urological
Keywords: Serenoa repens Urological symptoms hyperplasia BPH
Sponsor: University of Alabama at Birmingham
Start date: 2008-02-01; Completion date: 2010-12-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the CAMUS trial will be given one out of two possible treatments at random. One out of every two men would get an inactive placebo treatment. One out of every two men would get Saw palmetto pills.

This kind of scientific study is the best way to find out if the plant extracts really work to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study, men will not know which of the two treatments they are assigned to. They will be followed very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial will be studied over 72 weeks. Tests and all medications needed as part of the study will be provided at no charge to the participant. Participants will be responsible for all other costs not associated with the study tests and medications. 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.

Detailed description:
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic hyperplasia (BPH).

BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or urgent urination during the day or at night. Men with BPH can also have a weak urine stream, a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a need to strain to get urination started. BPH is NOT the same as prostate cancer.

A number of natural products (extracts of different plants) seem to be able to reduce the bothersome symptoms of BPH with very few side effects over a few months. One of the plant extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether these plant extracts will reduce the symptoms of BPH over a longer period of treatment.

Arms: arm 1: Participants will take one 320 mg placebo gelcap daily for 24 weeks one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps). arm 2: Extract of Serenoa Repens 320 mg once daily for 24 weeks (one gelcap); followed by 640 mg daily for 24 weeks (two gelcaps) followed by 960 mg daily for 24 weeks (three gelcaps).
Interventions: intervention 1: Saw Palmetto - first 24 weeks intervention 2: Placebo - first 24 weeks intervention 3: Saw Palmetto - weeks 24 - 48 intervention 4: Placebo - weeks 24 - 48 intervention 5: Saw Palmetto - weeks 48 - 72 intervention 6: Placebo - weeks 48 - 72
Intervention descriptions: intervention 1: Participants will take one 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. intervention 2: Participants will take one 320 mg chocolate-colored soft gelcaps containing a placebo for 24 weeks. intervention 3: Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. intervention 4: Participants will take 640 mg (2) chocolate-colored soft gelcaps containing a placebo for 24 weeks. intervention 5: Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract for 24 weeks. intervention 6: Participants will take 960 (3) mg chocolate-colored soft gelcaps containing a placebo for 24 weeks.

Protocol documents: