A Phase 2 interventional study of Maca Root and Placebo in Lower Urinary Tract Symptoms (LUTS), sponsored by RDC Clinical Pty Ltd. Not yet recruiting at 1 site in Australia. Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by RDC Clinical Pty Ltd · Phase 2, Interventional, and Treatment
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.
416 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →RDC Clinical Pty Ltd is the lead sponsor of 34 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take 2 capsules containing Macanity each day for 12 weeks
Dietary Supplement: Maca Root
Participants will take 2 capsules containing placebo each day for 12 weeks
Other: Placebo
Participants will take 2 capsules daily for 12 weeks, total daily dose of 290mg Macanity.
Also known as: Macanity
Participants will take 2 capsules of placebo daily for 12 weeks.
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.
Time frame: Baseline to 12 weeks
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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 27, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Lower Urinary Tract Symptoms →