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NCT07088419 · ClinicalTrials.gov registry record · Phase 2
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
A Phase 2 study of Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU), sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07088419: Recruiting Phase 2 study of Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU), sponsored by University of Washington.
NCT07088419 is a Phase 2 study of Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU) that is actively recruiting participants, run by University of Washington. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07088419, a Phase 2 study of Mycoplasma Genitalium and Non-gonococcal Urethritis (NGU), is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Food and Drug Administration (FDA) in May 2004 to treat other infections (i.e., trichomoniasis, giardiasis, amebiasis, bacterial vaginosis) but has not been systematically tested for effectiveness against M. genitalium. The dosing that the investigators are proposing does not significantly increase the risk associated with taking tinidazole and this investigation meets criteria for an IND exemption.
Primary Outcome
Microbiologic cure of M. genitalium will be determined at a test of cure visit. Microbiologic cure will be defined as a negative test for M. genitalium in a urine specimen using a nucleic acid amplification test.
Conditions Studied
Interventions
- DRUG Tinidazole
Study Locations (1)
Washington
- Harborview Medical Center, Public Health - Seattle & King County Sexual Health Clinic - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-07-23 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What NCT07088419 shows while recruiting
NCT07088419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Mycoplasma Genitalium appearing as the primary indexed condition, and to 1 intervention - of which Tinidazole is the first listed.
NCT07088419 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT07088419 about?
NCT07088419 is a clinical study titled ""Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"". The objective is to estimate the efficacy of tinidazole for the treatment of Mycoplasma genitalium (MG) among male patients who have been diagnosed with non-gonococcal urethritis (NGU) at the Public Health - Seattle \&King County (PHSKC) Sexual Health Clinic (SHC). Tinidazole was approved by the Foo...
What is the current status of trial NCT07088419?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-07-23. Estimated completion is 2026-08-31.
What conditions does trial NCT07088419 study?
This clinical trial studies the following conditions: Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU).
What interventions are being tested in trial NCT07088419?
The interventions under investigation include: Tinidazole (DRUG).
Who is sponsoring clinical trial NCT07088419?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07088419 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07088419's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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