Efficacy of Natural Extract 2007RD01 Combined With Saw Palmetto in Benign Prostatic Hyperplasia Patients Compared to Saw Palmetto

innoVactiv

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Dietary Supplement: Saw palmetto lipidic extract; Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797394

2007-RD-01-CLN

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

Treated

Experimental group

Treatment:

Dietary Supplement: Combination of 2007RD01 and saw palmetto lipidic extract

Control

Active Comparator group

Treatment:

Dietary Supplement: Saw palmetto lipidic extract