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Completed

NCT Number: NCT06504472

A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.

This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participants aged 40+
  • Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
  • Difficulty in getting or maintaining an erection
  • Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period

Exclusion criteria

  • Recent surgeries or invasive treatments
  • History of prostate or male reproductive cancers
  • Urinary issues caused by neurological conditions
  • Previous surgery on the genitals, prostate, bladder, or urethra
  • Known allergies to product ingredients
  • Diagnosed with chronic health conditions impacting study participation
  • Current substance abuse
  • Participation in other clinical trials
  • Taking medications or supplements targeting LUTS or erectile dysfunction

Treatment and study plan

ProstaThrive™ Supplement

Dietary Supplement

Participants in this arm will take three ProstaThrive™ capsules daily after the final meal of the day for 90 days.

Placebo

Dietary Supplement

Participants in this arm will take three placebo capsules daily after the final meal of the day for 90 days. The placebo capsules will contain an inert substance that mimics the appearance of the ProstaThrive™ supplement.

Primary outcomes

  1. Change in Lower Urinary Tract Symptoms (LUTS)

    Time frame: Baseline, Day 30, Day 60, and Day 90

    Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).

Secondary outcomes

  1. Change in Sexual Function and Performance

    Time frame: Baseline, Day 30, Day 60, and Day 90

    Measured by the ability to get and maintain an erection at Baseline, Day 30, Day 60, and Day 90 via study-specific questionnaires.

Sponsors and collaborators

Lead sponsor

Optimale

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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