Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT02886832
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of a Prostate Health Formulation
Sponsor:
Supplement Formulators, Inc.
Organization:
Study Overview
Official Title:
A Pilot, Open-label Study to Evaluate the Effects of a Prostate Health Formulation on Scores Attained From the International Prostate Symptom Score (I-PSS) Questionnaire Among Overall Healthy Male Participants Who Report Lower Urinary Tract Complaints
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: