NCT01021267

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

November 25, 2009

Last Update Submit

November 25, 2009

Conditions

Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Keywords

sexual dysfunctionsbenign prostatic hyperplasiasaw palmetto

Outcome Measures

Primary Outcomes (1)

  • Change of the brief Sexual Function Inventory

    day 0 and day 56

Secondary Outcomes (1)

  • change in IPSS change in Urolife Quality of Life questionnaire

    day 0 and day 56

Study Arms (1)

Saw palmetto berry extract

EXPERIMENTAL

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

Drug: Saw palmetto berry extract

Interventions

Saw palmetto berry extractDRUG

1x daily 1 capsule containing 320mg lipophilic extract

Also known as: Prostasan
Saw palmetto berry extract

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
  • IPSS \> 4
  • BSFI, sexual drive questions \< 5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Eugen Riedi

Chur, 7000, Switzerland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

saw palmetto extractProstasan

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Eugen Riedi, MD

    independent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Suter, M.Sc.

CONTACT

0041714546203a.suter@bioforce.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

CH(1)