NCT02886832

A Study to Evaluate the Effects of a Prostate Health Formulation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Prostate Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prostate Health formulation

Timeline

• Start date: 2016-09-21
• Primary completion: 2018-02-27
• Completion: 2018-03-27
• First posted: 2016-09-01
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States