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

NCT ID: NCT01021267

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Keywords

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sexual dysfunctions benign prostatic hyperplasia saw palmetto

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saw palmetto berry extract

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

Group Type EXPERIMENTAL

Saw palmetto berry extract

Intervention Type DRUG

1x daily 1 capsule containing 320mg lipophilic extract

Interventions

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Saw palmetto berry extract

1x daily 1 capsule containing 320mg lipophilic extract

Intervention Type DRUG

Other Intervention Names

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Prostasan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of London

OTHER

Sponsor Role collaborator

A. Vogel AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Bioforce AG

Principal Investigators

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Eugen Riedi, MD

Role: PRINCIPAL_INVESTIGATOR

independent

Locations

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Dr. Eugen Riedi

Chur, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Andy Suter, M.Sc.

Role: CONTACT

Phone: 0041714546203

Email: [email protected]

Other Identifiers

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920136

Identifier Type: -

Identifier Source: org_study_id