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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01021267
• Date of registration: 25/11/2009
• Prospective Registration: No
• Primary sponsor: Bioforce AG
• Public title: Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions
• Scientific title: Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
• Date of first enrolment: November 2009
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01021267
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Switzerland

Contacts

• Name: Eugen Riedi, MD
• Affiliation: independent

• Name: Andy Suter, M.Sc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Sexual Dysfunctions in Men With Benign Prostatic Hyperplasia

Intervention(s)

Drug: Saw palmetto berry extract

Primary Outcome(s)

Change of the brief Sexual Function Inventory [Time Frame: day 0 and day 56]

Secondary Outcome(s)

change in IPSS change in Urolife Quality of Life questionnaire [Time Frame: day 0 and day 56]

Secondary ID(s)

920136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of London