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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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01021267
Enrollment
50
Registered
2009-11-26
Start date
2009-11-30
Completion date
2010-09-30
Last updated
2009-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Keywords

sexual dysfunctions, benign prostatic hyperplasia, saw palmetto

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.

Interventions

DRUGSaw palmetto berry extract

1x daily 1 capsule containing 320mg lipophilic extract

Sponsors

University of London
CollaboratorOTHER
A. Vogel AG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change of the brief Sexual Function Inventoryday 0 and day 56

Secondary

MeasureTime frame
change in IPSS change in Urolife Quality of Life questionnaireday 0 and day 56

Countries

Switzerland

Contacts

Primary ContactAndy Suter, M.Sc.
a.suter@bioforce.ch0041714546203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026