Trial · NCT00322465
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
NCT00322465, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2011-08-17
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole). Trials, record NCT00322465. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00322465
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)
- NCT number
- NCT00322465
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 305 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Urethritis
- Interventions
- Doxycycline, Placebo, Tinidazole, Azithromycin
- First posted
- 2006-05-08
- Last updated
- 2026-08-27
- Results first posted
- 2011-08-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | 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). |
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | 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). |
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Stomach Upset | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | At all study visits, unsolicited adverse events were recorded. |
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting of Abdominal Pain | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | 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). |
| Primary | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Diarrhea | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | 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). |
| Primary | Percentage of Participants Achieving Clinical Cure of Non-gonococcal Urethritis (NGU) With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: \[Persistent symptoms AND \>= 5 polymorphonuclear leukocytes (PMNs) per 3-5 oil immersion fields (regardless of urethral discharge)\] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: \>= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs) |
| Secondary | Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Clinical Cure of NGU: Did not meet criteria for clinical failure at last evaluable follow-up visit. Clinical Failure at first follow-up: \[Persistent symptoms AND \>= 5 PMNs per 3-5 oil immersion fields (regardless of urethral discharge)\] OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs). Clinical Failure at second follow-up: \>= 5 PMNs per 3-5 oil immersion fields (regardless of symptoms or presence of urethral discharge) OR Persistent urethral discharge on exam (regardless of symptoms or number of PMNs) |
| Secondary | Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Microbiological cure of Chlamydia trachomatis refers to the percentage of men with NGU who were negative for Chlamydia trachomatis at the last available result and had been positive for Chlamydia trachomatis at baseline. |
| Secondary | Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Microbiological cure of Trichomonas vaginalis refers to the percentage of men with NGU who were negative for Trichomonas vaginalis (swab and urine specimens) at the last available result and had been positive for Trichomonas vaginalis at baseline (swab or urine specimen). |
| Secondary | Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Microbiological Cure of Mycoplasma Genitalium refers to the percentage of men with NGU who were negative for Mycoplasma Genitalium at the last available result and had been positive for Mycoplasma Genitalium at baseline. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Participants | NUMBER |
| PRIMARY | Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Modified intent-to-treat population was comprised of all subjects randomized who received at least one dose of study drug therapy or placebo | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Microbiological Cure of Chlamydia Trachomatis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Microbiological Cure of Trichomonas Vaginalis With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Microbiological Cure of Mycoplasma Genitalium With Doxycycline Versus Doxycycline With Tinidazole; and Azithromycin Versus Azithromycin With Tinidazole | First follow-up visit (Day 15-19), second follow-up visit (Day 35-45) | Participants who were positive at baseline, returned for follow-up, and had evaluable test results. | Percentage of participants | NUMBER |
| SECONDARY | Prevalence of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Baseline (enrollment visit) | All study participants with evaluable baseline test results. | Percentage of participants | NUMBER |
| SECONDARY | Prevalence of Trichomonas Vaginalis (Swab or Urine Specimen) in Men With Non-gonococcal Urethritis | Baseline (enrollment visit) | All study participants with evaluable baseline test results. | Percentage of participants | NUMBER |
| SECONDARY | Prevalence of Mycoplasma Genitalium in Men With Non-gonococcal Urethritis | Baseline (enrollment) | All study participants with evaluable baseline test results. | Percentage of participants | NUMBER |
| SECONDARY | Clinical, Behavioral, and Demographic Predictors of Chlamydia Trachomatis in Men With Non-gonococcal Urethritis | Baseline (enrollment visit) | All study participants who met major eligibility criteria (per protocol) with evaluable baseline measures. | Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | Doxycycline | 3 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | Doxycycline + Tinidazole | 4 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | Azithromycin | 0 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Nausea | Azithromycin + Tinidazole | 4 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | Doxycycline | 4 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | Doxycycline + Tinidazole | 2 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | Azithromycin | 0 | Participants | ||
| Safety and Tolerability of Doxycycline/Tinidazole and Azithromycin/Tinidazole: Number of Participants Reporting Vomiting | Azithromycin + Tinidazole | 0 | Participants | ||
| Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) | Doxycycline + (Doxycycline + Tinidazole) | 49 | Percentage of participants | ||
| Percentage of Participants Achieving Clinical Cure of NGU With (Doxycycline Plus Doxycycline/Tinidazole) Versus (Azithromycin Plus Azithromycin/Tinidazole) | Azithromycin + (Azithromycin + Tinidazole) | 44 | Percentage of participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline | 76 | |
| Overall Study | STARTED | Doxycycline + Tinidazole | 73 | |
| Overall Study | STARTED | Azithromycin | 77 | |
| Overall Study | STARTED | Azithromycin + Tinidazole | 79 | |
| Overall Study | COMPLETED | Doxycycline | 56 | |
| Overall Study | COMPLETED | Doxycycline + Tinidazole | 49 | |
| Overall Study | COMPLETED | Azithromycin | 51 | |
| Overall Study | COMPLETED | Azithromycin + Tinidazole | 53 | |
| Overall Study | NOT COMPLETED | Doxycycline | 20 | |
| Overall Study | NOT COMPLETED | Doxycycline + Tinidazole | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Doxycycline | 6 | 76 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Doxycycline + Tinidazole | 5 | 73 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Azithromycin | 3 | 77 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Azithromycin + Tinidazole | 5 | 79 | 5 |
| other | Balanoposthitis | Reproductive system and breast disorders | Doxycycline | 0 | 76 | 0 |
| other | Balanoposthitis | Reproductive system and breast disorders | Doxycycline + Tinidazole | 0 | 73 | 0 |
| other | Balanoposthitis | Reproductive system and breast disorders | Azithromycin | 0 | 77 | 0 |
| other | Balanoposthitis | Reproductive system and breast disorders | Azithromycin + Tinidazole | 1 | 79 | 1 |
| other | Blister | Skin and subcutaneous tissue disorders | Doxycycline | 0 | 76 | 0 |
| other | Blister | Skin and subcutaneous tissue disorders | Doxycycline + Tinidazole | 0 | 73 | 0 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxycycline | ||
| Total, all-cause mortality | Doxycycline + Tinidazole | ||
| Total, all-cause mortality | Azithromycin | ||
| Total, all-cause mortality | Azithromycin + Tinidazole | ||
| Total, other adverse events | Doxycycline | 18 | 76 |
| Total, other adverse events | Doxycycline + Tinidazole | 25 | 73 |
| Total, other adverse events | Azithromycin | 11 | 77 |
| Total, other adverse events | Azithromycin + Tinidazole | 24 | 79 |
| Total, serious adverse events | Doxycycline | 0 | 76 |
| Total, serious adverse events | Doxycycline + Tinidazole | 0 | 73 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21288838 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00322465
GET https://conductscience.org/api/trials/v1/NCT00322465/results?page=2