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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Bioforce AG.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

University of London

Information provided by:

Bioforce AG

ClinicalTrials.gov Identifier:

NCT01021267

First received: November 25, 2009

Last updated: NA

Last verified: November 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 25, 2009

Last Updated Date

November 25, 2009

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change of the brief Sexual Function Inventory [ Time Frame: day 0 and day 56 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

change in IPSS change in Urolife Quality of Life questionnaire [ Time Frame: day 0 and day 56 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: Saw palmetto berry extract

1x daily 1 capsule containing 320mg lipophilic extract

Other Name: Prostasan

Study Arm (s)

Experimental: Saw palmetto berry extract

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

Intervention: Drug: Saw palmetto berry extract

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andy Suter, M.Sc.

0041714546203

a.suter@bioforce.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01021267

Other Study ID Numbers ^ICMJE

920136

Has Data Monitoring Committee

Responsible Party

Andy Suter, Head of Med. Dept., Bioforce AG

Study Sponsor ^ICMJE

Bioforce AG

Collaborators ^ICMJE

University of London

Investigators ^ICMJE

Principal Investigator:

Eugen Riedi, MD

independent

Information Provided By

Bioforce AG

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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