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A Study to Evaluate the Effects of a Prostate Health Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02886832
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Supplement Formulators, Inc.

No Study Results Posted on ClinicalTrials.gov for this Study
  Recruitment Status : Completed
  Actual Primary Completion Date : February 27, 2018
  Actual Study Completion Date : March 27, 2018
Publications:
Aguilar F, Autrup H, Barlow S et al. Scientific Opinion of the Panel onf Food Additives, Flavourings, Processing Adids and Materials in Contact with Food on a request from the Commission on the safety in use of lycopene as a food colour. The EFSA Journal. 2008;675:1-66.
Andro M, Riffaud J. Pygeum Africanum extract for the treatment of patients with benign prostatic hyperplasia: A review of 25 years of published experience. Current Therapeutic Research. 1995;56(8):796-817.
ConvertUnits.com. Convert lbs to kg - Conversion of Measurement Units. http://www.convertunits.com/from/lbs/to/kg. Copyright 2016. Accessed 6/20/2016. Cui Y, Winton M, Zhang Z et al. Dietary boron intake and prostate cancer risk. Oncology Reports. 2004;11(4):887-892.
Culver B, Hubbard S. 1996. Inorganic boron health effects in humans: An aid to risk assessment and clinical judgment. J Trace Elem Exp Med 9:175-184.
DHHS. U. S. Department of Health and Human Services. Center for Drug Evaluation and Research. Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapetuics in Adult Heathy Volunteers. 7/2005. http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf. Accessed 6/21/2016.
Kava. In: Natural Medicines Comprehensive Database. Stockton, CA: Therapeutic Research Faculty. [Updated January 6, 2016; Accessed May 24, 2016]. http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?cs=OSU&s=ND&pt=100&id=872&ds =&name=KAVA&searchid=37784702
Mace, A.E. (1964), Sample Size Determination, New York: Reinhold Publishing Corporation
Risk Profile. Beta-sitosterol. CAS No. 83-46-5. http://www.mattilsynet.no/kosmetikk/stoffer_i_kosmetikk/risk_profile_betasitosterol.11370/binary/Risk%20Profile%20Beta-Sitosterol. 8/27/2012. Accessed 6/20/2016.
Stokinger HE. 1981. The halogens and nonmetals boron and silicon. In: Clayton GD, Clayton FE, eds. Patty's Industrial Hygiene and Toxicology, Vol. 2B. New York: John Wiley and Sons. Pp. 2978- 3005.