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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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ClinicalTrials.gov Identifier: NCT01021267
Recruitment Status : Unknown
Verified November 2009 by Bioforce AG.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2009
Last Update Posted : November 26, 2009
Sponsor:
Collaborator:
University of London
Information provided by:
Bioforce AG

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia Drug: Saw palmetto berry extract Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
Study Start Date : November 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Prostasan



Primary Outcome Measures :
  1. Change of the brief Sexual Function Inventory [ Time Frame: day 0 and day 56 ]

Secondary Outcome Measures :
  1. change in IPSS change in Urolife Quality of Life questionnaire [ Time Frame: day 0 and day 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021267


Contacts
Contact: Andy Suter, M.Sc. 0041714546203 a.suter@bioforce.ch

Locations
Switzerland
Dr. Eugen Riedi
Chur, Switzerland, 7000
Sponsors and Collaborators
Bioforce AG
University of London
Investigators
Principal Investigator: Eugen Riedi, MD independent

Responsible Party: Andy Suter, Head of Med. Dept., Bioforce AG
ClinicalTrials.gov Identifier: NCT01021267     History of Changes
Other Study ID Numbers: 920136
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: November 26, 2009
Last Verified: November 2009

Keywords provided by Bioforce AG:
sexual dysfunctions
benign prostatic hyperplasia
saw palmetto

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Saw palmetto extract
Urological Agents