NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 204 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2009 to Apr 20, 2009
    • Start date: Nov 2006 to Nov 17, 2006
    • Study sites revised (4)
    v204
  2. Re-verified, no change to tracked fieldsv203
  3. Interventions: Azithromycin (Drug), Doxycycline (Drug), Placebo Azithromycin (Drug), Placebo Doxycycline (Drug), Placebo Tinidazole (Drug), Tinidazole… to Azithromycin (Drug), Doxycycline (Drug), Placebo (Other), Tinidazole (Drug)
    • Study sites revised (4)
    v202
  4. Eligibility criteria revised
    • Study sites revised (4)
    v201
  5. Eligibility criteria revisedv200
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  1. Results first posted: Aug 17, 2011v199 Show 4 more changesShow less
    • Primary endpoints: 2 to 6
    • Interventions: Azithromycin (Drug), Doxycycline (Drug), Placebo (Drug), Tinidazole (Drug) to Azithromycin (Drug), Doxycycline (Drug), Placebo Azithromycin (Drug), Placebo Doxycycline (Drug), Placebo Tinidazole (Drug), Tinidazole…
    • Secondary endpoints: 4 to 11
    • Study description expanded, about 3 words
  2. 5 versions Re-verified since Jan 7, 2010, no change to tracked fieldsv194-v198
  3. Secondary endpoints reorderedv193
  4. Secondary endpoints reorderedv192
  5. 2 versions Re-verified since Dec 3, 2009, no change to tracked fieldsv190-v191
  6. Primary and study completion dates: May 2009 to Apr 2009v189
  7. Secondary endpoints reorderedv188
  8. 6 versions Re-verified since Oct 8, 2009, no change to tracked fieldsv182-v187
  9. Secondary endpoints reorderedv181
  10. Re-verified, no change to tracked fieldsv180
  11. Secondary endpoints reorderedv179
  12. Secondary endpoints reorderedv178
  13. Secondary endpoints reorderedv177
  14. Secondary endpoints reorderedv176
  15. 6 versions Re-verified since Jul 16, 2009, no change to tracked fieldsv170-v175
  16. Secondary endpoints reorderedv169
  17. Re-verified, no change to tracked fieldsv168
  18. Trial status: Active, Not Recruiting to Completedv167
  19. 2 versions Re-verified since Jun 11, 2009, no change to tracked fieldsv165-v166
  20. Secondary endpoints reorderedv164
  21. Re-verified, no change to tracked fieldsv163
  22. Secondary endpoints reorderedv162
  23. 4 versions Re-verified since May 1, 2009, no change to tracked fieldsv158-v161
  24. Secondary endpoints reorderedv157
  25. Re-verified, no change to tracked fieldsv156
  26. Primary and study completion dates: Nov 2009 to May 2009v155
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00322465
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Urethritis
Related terms Urethritis
Enrollment 305 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov