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NCT06351683 · ClinicalTrials.gov registry record · Phase 2
Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome
A Phase 2 study of Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, sponsored by Iman Al-Naggar, PhD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06351683: Recruiting Phase 2 study of Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, sponsored by Iman Al-Naggar, PhD.
NCT06351683 is a Phase 2 study of Lower Urinary Tract Symptoms and Overactive Bladder Syndrome that is actively recruiting participants, run by Iman Al-Naggar, PhD. The registered enrollment target is 50 participants, below the 748-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06351683, a Phase 2 study of Lower Urinary Tract Symptoms and Overactive Bladder Syndrome, is actively recruiting participants, sponsored by Iman Al-Naggar, PhD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women 50 years and older who have the metabolic syndrome. The main questions it aims to answer are: * Is the study design feasible and acceptable to participants? * Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)? Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.)
Primary Outcome
The OBSS is a validated bladder symptom questionnaire routinely used in assessing lower urinary tract symptoms and overactive bladder syndrome. The OABSS questionnaire consists of 4 questions and has a minimum score of 0 and a maximum score of 15. Scores on the OABSS of ≤5 are defined as mild, those of 6-11 as moderate, and those of ≥12 as severe LUTS.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MitoQ (mitoquinol mesylate)
Study Locations (1)
Connecticut
- UConn Health - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What NCT06351683 shows while recruiting
NCT06351683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 748-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Lower Urinary Tract Symptoms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06351683 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06351683 about?
NCT06351683 is a clinical study titled "Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome". The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women 50 years and older who have the metabolic syndrome. The main questions it aims to answer are: * Is the study design feasible and accept...
What is the current status of trial NCT06351683?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-04-03. Estimated completion is 2025-12-31.
What conditions does trial NCT06351683 study?
This clinical trial studies the following conditions: Lower Urinary Tract Symptoms, Overactive Bladder Syndrome.
What interventions are being tested in trial NCT06351683?
The interventions under investigation include: Placebo (OTHER), MitoQ (mitoquinol mesylate) (DRUG).
Who is sponsoring clinical trial NCT06351683?
This trial is sponsored by Iman Al-Naggar, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351683 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06351683's enrollment target sits among peer trials
50 16th of 21 higher than 6 of 21 other Lower Urinary Tract Symptoms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lower Urinary Tract Symptoms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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