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

NCT07816172 | Not Yet Recruiting Phase 2

• 1 other identifier: EXMENS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Urinary Tract Symptoms (LUTS)

Keywords

LUTS

Outcome Measures

Primary Outcomes (1)

• Change from baseline to the end of the study period in IPSS

  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.

  Baseline to 12 weeks

Secondary Outcomes (4)

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

  Baseline to 12 weeks

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

  week 6 and week 12

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

  Week 6, week 12

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

  Baseline to 12 weeks

Study Arms (2)

Macanity

EXPERIMENTAL

Participants will take 2 capsules containing Macanity each day for 12 weeks

Dietary Supplement: Maca Root

Placebo

PLACEBO COMPARATOR

Participants will take 2 capsules containing placebo each day for 12 weeks

Other: Placebo

Interventions

Maca Root DIETARY_SUPPLEMENT

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

Also known as: Macanity

Macanity

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Laboratoires Expanscience SAS: collaborator

Study Sites (1)

RDC Clinical

Fortitude Valley, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaëtan Boyer

  Laboratoires Expanscience SAS

  STUDY DIRECTOR

Central Study Contacts

Amanda Rao

CONTACT

+61(0)731024486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-07

Locations

AU (1)