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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01021267
Other study ID # 920136
Secondary ID
Status Unknown status
Phase Phase 4
First received November 25, 2009
Last updated November 25, 2009
Start date November 2009
Est. completion date September 2010

Study information

Verified date November 2009
Source Bioforce AG
Contact Andy Suter, M.Sc.
Phone 0041714546203
Email a.suter@bioforce.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Unknown status
Enrollment 50
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Saw palmetto berry extract
1x daily 1 capsule containing 320mg lipophilic extract

Locations

Country Name City State
Switzerland Dr. Eugen Riedi Chur

Sponsors (2)

Lead Sponsor Collaborator
Bioforce AG University of London

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of the brief Sexual Function Inventory day 0 and day 56
Secondary change in IPSS change in Urolife Quality of Life questionnaire day 0 and day 56