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NCT00322465 · ClinicalTrials.gov registry record · Phase 2
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
A Phase 2 study of Urethritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 305
- Enrollment target
- 4
- Study locations
NCT00322465: Completed Phase 2 study of Urethritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00322465 is a Phase 2 study of Urethritis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 305 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00322465, a Phase 2 study of Urethritis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 305 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.
Primary Outcome
At all study visits, unsolicited adverse events were recorded. Nausea, Vomiting, Abdominal pain, and Diarrhea were recorded using National Cancer Institute Common Toxicity Criteria (Version 3.0).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Azithromycin
- DRUG Tinidazole
- DRUG Doxycycline
Study Locations (4)
Alabama
- University of Alabama Hospital - Infectious Diseases - Birmingham
Louisiana
- Delgado Personal Health Center - New Orleans
Maryland
- Johns Hopkins Hospital - Emergency Medicine - Baltimore
North Carolina
- University of North Carolina School of Medicine - Center for Infectious Diseases - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00322465 record still lists
NCT00322465 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher).
The record links to 1 condition, with Urethritis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00322465 reports a single indexed study location in Alabama, Louisiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT00322465 about?
NCT00322465 is a clinical study titled "NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)". This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during ...
What is the current status of trial NCT00322465?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 305 participants. The study started on 2006-11. Estimated completion is 2009-04.
What conditions does trial NCT00322465 study?
This clinical trial studies the following conditions: Urethritis.
What interventions are being tested in trial NCT00322465?
The interventions under investigation include: Placebo (OTHER), Azithromycin (DRUG), Tinidazole (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT00322465?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00322465 being conducted?
This trial has 4 study locations across Alabama, Louisiana, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00322465's enrollment target sits among peer trials
305 166th of 2000 higher than 1,835 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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