Lower Urinary Tract Symptoms (LUTS)Phase 2NCT07816172
Effects of Macanity on Urinary Health in Males With Lower Urinary Tract Symptoms
A Phase 2 study testing Maca Root in people with Lower Urinary Tract Symptoms (LUTS), run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- Maca Root
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
RDC Clinical
Fortitude Valley, Queensland, 4006
Amanda Rao, +61 (0) 731024486, research@rdcglobal.com.au
Amanda Rao, PhD
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Macanity on Urinary Health in Males Experiencing 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.
- Conditions
- Lower Urinary Tract Symptoms (LUTS)
- Being tested
- Maca Root, Placebo
- Keywords
- LUTS
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maca RootDietary supplement
Also called Macanity
Participants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity.
PlaceboOther
Participants will take 2 capsules of placebo daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Macanity | Experimental | Participants will take 2 capsules containing Macanity each day for 12 weeks Receives: Dietary Supplement: Maca Root |
| Placebo | Placebo comparator | Participants will take 2 capsules containing placebo each day for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline to 12 weeks
Change from baseline to the end of the study period in overall improvement via the PGI-C
Change from baseline to the end of the study period in overall improvement via the Patient Global Impression of Change (PGI-C) questionnaire
Measured: week 6 and week 12
Change from baseline to the end of the study period in Self-Assessment Questionnaire
Change from baseline to the end of the study period in Self-Assessment Questionnaire
Measured: Week 6, week 12
Change from baseline to the end of the study period in Safety via AE monitoring
Change from baseline to the end of the study period in Safety via AE monitoring
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Symptoms (LUTS)Studies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratoires Expanscience SAS
- Responsible party
- Sponsor
- Investigators
- Gaëtan Boyer, Study director, Laboratoires Expanscience SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816172
- Sponsor's protocol ID
- EXMENS
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Macanity on Urinary Health in Males Experiencing Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT07816172
- Acronym / sponsor ID
- EXMENS
- Conditions
- Lower Urinary Tract Symptoms (LUTS)
- Keywords
- LUTS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Laboratoires Expanscience SAS
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macanity | Experimental | Dietary Supplement: Maca RootParticipants will take 2 capsules containing Macanity each day for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take 2 capsules containing placebo each day for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maca RootAlso: MacanityParticipants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity. | Dietary supplement | Macanity |
| PlaceboParticipants will take 2 capsules of placebo daily for 12 weeks. | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
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 overall improvement via the PGI-C
Time frame: week 6 and week 12
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 Safety via AE monitoring
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaëtan Boyer study director
Laboratoires Expanscience SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maca Root in people with Lower Urinary Tract Symptoms (LUTS), run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rao (+61(0)731024486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to the end of the study period in IPSS (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.