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

November 25, 2009
November 25, 2009
November 2009
September 2010   (final data collection date for primary outcome measure)
Change of the brief Sexual Function Inventory [ Time Frame: day 0 and day 56 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
change in IPSS change in Urolife Quality of Life questionnaire [ Time Frame: day 0 and day 56 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia
Drug: Saw palmetto berry extract
1x daily 1 capsule containing 320mg lipophilic extract
Other Name: Prostasan
Experimental: Saw palmetto berry extract
Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%
Intervention: Drug: Saw palmetto berry extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 80 Years
No
Contact: Andy Suter, M.Sc. 0041714546203 a.suter@bioforce.ch
Switzerland
 
NCT01021267
920136
No
Andy Suter, Head of Med. Dept., Bioforce AG
Bioforce AG
University of London
Principal Investigator: Eugen Riedi, MD independent
Bioforce AG
November 2009

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