Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions

A. Vogel AG

Status and phase: Unknown; Phase 4

Conditions: Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Treatments: Drug: Saw palmetto berry extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01021267

920136

Details and patient eligibility

About

Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
• IPSS > 4
• BSFI, sexual drive questions < 5

Exclusion criteria

• Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
• Patients with severe vascular disorders (microangiopathies)
• Patients with known neuropathies
• Severe diabetes mellitus
• Patients with hypertension who are for less than two months on a stable antihypertensive medication
• Known bad compliance of the patient

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Saw palmetto berry extract

Experimental group

Description:

Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%

Treatment:

Drug: Saw palmetto berry extract