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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

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
  Purpose

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 Intervention Phase
Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia
 Drug: Saw palmetto berry extract
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Bioforce AG:

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

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

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Andy Suter, Head of Med. Dept., Bioforce AG
ClinicalTrials.gov Identifier: NCT01021267     History of Changes
Other Study ID Numbers: 920136
Study First Received: November 25, 2009
Last Updated: November 25, 2009
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Sexual Dysfunctions, Psychological
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Sexual and Gender Disorders
Mental Disorders
 Permixon
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists

ClinicalTrials.gov processed this record on June 18, 2013