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

Primary Purpose

Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Saw palmetto berry extract
Sponsored by
A. Vogel AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia focused on measuring sexual dysfunctions, benign prostatic hyperplasia, saw palmetto

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Dr. Eugen Riedi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saw palmetto berry extract

Arm Description

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

Outcomes

Primary Outcome Measures

Change of the brief Sexual Function Inventory

Secondary Outcome Measures

change in IPSS change in Urolife Quality of Life questionnaire

Full Information

First Posted
November 25, 2009
Last Updated
November 25, 2009
Sponsor
A. Vogel AG
Collaborators
University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01021267
Brief Title
Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
Official Title
Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
A. Vogel AG
Collaborators
University of London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia
Keywords
sexual dysfunctions, benign prostatic hyperplasia, saw palmetto

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saw palmetto berry extract
Arm Type
Experimental
Arm Description
Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%
Intervention Type
Drug
Intervention Name(s)
Saw palmetto berry extract
Other Intervention Name(s)
Prostasan
Intervention Description
1x daily 1 capsule containing 320mg lipophilic extract
Primary Outcome Measure Information:
Title
Change of the brief Sexual Function Inventory
Time Frame
day 0 and day 56
Secondary Outcome Measure Information:
Title
change in IPSS change in Urolife Quality of Life questionnaire
Time Frame
day 0 and day 56

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Suter, M.Sc.
Phone
0041714546203
Email
a.suter@bioforce.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugen Riedi, MD
Organizational Affiliation
independent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Eugen Riedi
City
Chur
ZIP/Postal Code
7000
Country
Switzerland

12. IPD Sharing Statement

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

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