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

November 25, 2009 updated by: A. Vogel AG

Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saw palmetto berry extract
Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%
Drug: Saw palmetto berry extract
1x daily 1 capsule containing 320mg lipophilic extract
Other Names:
  • Prostasan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the brief Sexual Function Inventory
Time Frame: day 0 and day 56
day 0 and day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
change in IPSS change in Urolife Quality of Life questionnaire
Time Frame: day 0 and day 56
day 0 and day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A. Vogel AG

Collaborators

University of London

Investigators

  • Principal Investigator: Eugen Riedi, MD, Independent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 26, 2009

Study Record Updates

Last Update Posted (Estimate)

November 26, 2009

Last Update Submitted That Met QC Criteria

November 25, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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