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NCT Number: NCT07816172

Effects of Macanity on Urinary Health in Males With Lower Urinary Tract Symptoms

The goal of this study is to evaluate the effects of Macanity on urinary health in males experiencing LUTS. Males aged over 40 years of age who experience LUTS will be recruited and assigned to a study treatment which they will take for 12 weeks. They will have 3 remote visits over 12 weeks.

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Key information

Conditions

Lower Urinary Tract Symptoms (LUTS) Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult males > 40 years of age experiencing LUTS
  • Generally healthy
  • BMI 18-32 kg/m2
  • Moderate International Prostate Symptom Score (IPSS) score: 8-19.
  • IPSS quality of life (QoL) score >3
  • Able to provide informed consent
  • Agree to not participate in another clinical trial while enrolled in this trial

Exclusion criteria

  • Have a serious illness e.g. mood disorders such as depression or bipolar disorder, anxiety, neurological disorders such as MS, kidney disease, liver disease, heart conditions, hypertension
  • Have an unstable illness e.g. diabetes and thyroid gland dysfunction, uncontrolled hypertension with diastolic blood pressure > 100 mmHg
  • Prostate specific antigen (PSA) testing > 2 years ago
  • Have used a drug/supplement for benign prostatic hyperplasia (BPH) or other urological symptoms within the last 30 days
  • Have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis
  • Have had urogenital surgery within the last 6 months
  • Have had bladder biopsy and/or cystoscopy and biopsy within the past 30 days.
  • Have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones)
  • Current malignancy including prostatic cancer (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
  • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; antihypertensive medications, tetracyclic antidepressants, thyroid medications
  • Active smokers, nicotine use or drug (prescription or illegal substances) abuse
  • Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
  • Allergic to any of the ingredients in active or placebo formula, or an allergy to cruciferous vegetables
  • Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
  • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

Treatment and study plan

Maca Root

Dietary Supplement

Participants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity.

Other names: Macanity

Placebo

Other

Participants will take 2 capsules of placebo daily for 12 weeks.

Primary outcomes

  1. Change from baseline to the end of the study period in IPSS

    Time frame: Baseline to 12 weeks

    Change from baseline to the end of the study period in overall IPSS score, IPSS QoL score and individual IPSS items between baseline and each assessment time.

Secondary outcomes

  1. Change from baseline to the end of the study period in urinary symptoms and their effect on QoL

    Time frame: Baseline to 12 weeks

    Change from baseline to the end of the study period in urinary symptoms and their effect on QoL via the Incontinence Quality of Life questionnaire (I-QOL).

  2. Change from baseline to the end of the study period in overall improvement via the PGI-C

    Time frame: week 6 and week 12

    Change from baseline to the end of the study period in overall improvement via the Patient Global Impression of Change (PGI-C) questionnaire

  3. Change from baseline to the end of the study period in Self-Assessment Questionnaire

    Time frame: Week 6, week 12

    Change from baseline to the end of the study period in Self-Assessment Questionnaire

  4. Change from baseline to the end of the study period in Safety via AE monitoring

    Time frame: Baseline to 12 weeks

    Change from baseline to the end of the study period in Safety via AE monitoring

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Rao

CONTACT

[email protected]

+61(0)731024486

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Laboratoires Expanscience SAS

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Macanity on Urinary Health in Males Experiencing Lower Urinary Tract Symptoms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

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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