A Study to Evaluate the Effects of a Prostate Health Formulation
Summary
The purpose of this study is to assess the efficacy of a Prostate Health formulation on scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will also be assessed.
Description
This study is a pilot, open-label study to evaluate the efficacy, safety and tolerability of a Prostate Health formulation. Each subject will receive a specific dose of the formulation once daily.
Participants will undergo assessments of blood tests, vital signs, body weight, BMI with completion of questionnaires.
The primary objective of the study is to assess effectiveness of the Prostate Health formulation on the I-PSS score.
Secondary objectives:
1. To assess the I-PSS "Quality of Life" question score
2. To assess the PSA level
3. To assess the IIEF-5 questionnaire score
4. To assess body weight
5. To assess BMI
6. To assess the score on a questionnaire for health-related quality of life
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Conditions
Prostate Health
Intervention
Prostate Health formulation
Location
Life Extension Clinical Research, Inc.
Fort Lauderdale
Florida
United States
33308
Status
Recruiting
Source
Supplement Formulators, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02886832
- ClinicalTrials.gov processed this data on August 31, 2016
Published on BioPortfolio: 2016-09-01T14:53:21-0400
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Medical and Biotech [MESH] Definitions
Prostatic Secretory Proteins
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
Prostate-specific Antigen
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Transurethral Resection Of Prostate
Removal of all or part of the PROSTATE, often using a cystoscope and/or resectoscope passed through the URETHRA.
Tissue Kallikreins
A family of trypsin-like SERINE ENDOPEPTIDASES that are expressed in a variety of cell types including human prostate epithelial cells. They are formed from tissue prokallikrein by action with TRYPSIN. They are highly similar to PROSTATE-SPECIFIC ANTIGEN. EC 3.4.21.35.
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
