Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto
Lead SponsorinnoVactiv Inc.
StatusCompleted No Results Posted
Indication/ConditionBenign Prostatic Hyperplasia
Intervention/Treatmentsaw palmetto saw palmetto lipidic extract 2007rd01 ...
The purpose of this study is to determine if the combination of 2007RD01, a natural extract, and saw palmetto lipidic extract, is more effective at treating lower urinary tract symptoms associated with benign prostatic hyperplasia than saw palmetto lipidic extract alone.
Oral administration of one capsule containing a combination of 250 mg of 2007RD01 (a natural extract) and 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
Oral administration of one capsule of 160 mg of saw palmetto lipidic extract plus inactive fillers, twice a day between meals
Inclusion Criteria: Patient must be an adult man aged between 50 and 75 Patient must have Benign Prostatic Hyperplasia symptoms Exclusion Criteria: Patient has a malfunction of the urinary tract, is suffering from acute urinary retention, or is suffering from prostate cancer or urinary tract infection Patient has been subjected to surgery of the prostate, bladder or urethra Patient has taken a 5-alpha-reductase inhibitor in the 6-month period preceding screening Patient has taken an alpha-blocker in the 2-week period preceding screening