Trial · NCT00334633

Treatment of Bacterial Vaginosis (BV) With Tinidazole

NCT00334633, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2011-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Bacterial Vaginosis (BV) With Tinidazole. Trials, record NCT00334633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00334633

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Bacterial Vaginosis (BV) With Tinidazole
NCT number: NCT00334633
Status: Completed
Phases: Phase 4
Enrollment: 593 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Bacterial Vaginosis
Interventions: tinidazole, metronidazole
First posted: 2006-06-08
Last updated: 2017-12-02
Results first posted: 2011-06-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cure of Bacterial Vaginosis	one month	resolution of Amsel criteria for bacterial vaginosis
Secondary	Recurrence of BV	baseline to 4 weeks

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cure of Bacterial Vaginosis	one month	ITT	participants	NUMBER
SECONDARY	Recurrence of BV	baseline to 4 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Cure of Bacterial Vaginosis	Metronidazole	75	participants
Cure of Bacterial Vaginosis	Tinidazole 500 mg	73	participants
Cure of Bacterial Vaginosis	Tinidazole 1 gm	77	participants
Recurrence of BV	Control	42	Participants
Recurrence of BV	Tinidazole 500	45	Participants
Recurrence of BV	Tinidazole 1 gm	37	Participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metronidazole	197
Overall Study	STARTED	Tinidazole 500 mg	200
Overall Study	STARTED	Tinidazole 1 gm	196
Overall Study	COMPLETED	Metronidazole	117
Overall Study	COMPLETED	Tinidazole 500 mg	118
Overall Study	COMPLETED	Tinidazole 1 gm	114
Overall Study	NOT COMPLETED	Metronidazole	80
Overall Study	NOT COMPLETED	Tinidazole 500 mg	82
Overall Study	NOT COMPLETED	Tinidazole 1 gm	82

Source ClinicalTrials.gov

Adverse events9

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	vaginal candidiasis	Infections and infestations	Metronidazole	32	126	32
other	vaginal candidiasis	Infections and infestations	Tinidazole 500 mg	33	161	33
other	vaginal candidiasis	Infections and infestations	Tinidazole 1 gm	27	196	27
other	gastrointestinal	Gastrointestinal disorders	Metronidazole	39	126	39
other	gastrointestinal	Gastrointestinal disorders	Tinidazole 500 mg	54	161	54
other	gastrointestinal	Gastrointestinal disorders	Tinidazole 1 gm	91	196	91
other	headache	Nervous system disorders	Metronidazole	16	126	16
other	headache	Nervous system disorders	Tinidazole 500 mg	22	161	22
other	headache	Nervous system disorders	Tinidazole 1 gm	27	196	27

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metronidazole
Total, all-cause mortality	Tinidazole 500 mg
Total, all-cause mortality	Tinidazole 1 gm
Total, other adverse events	Metronidazole	87	197
Total, other adverse events	Tinidazole 500 mg	109	200
Total, other adverse events	Tinidazole 1 gm	145	196
Total, serious adverse events	Metronidazole	0	197
Total, serious adverse events	Tinidazole 500 mg	0	200
Total, serious adverse events	Tinidazole 1 gm	0	196

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AI058033	Tinidazole for the Treatment of Bacterial Vaginosis	SCHWEBKE, JANE R.	UNIVERSITY OF ALABAMA AT BIRMINGHAM	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2004 to 2007

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00334633

GET https://conductscience.org/api/trials/v1/NCT00334633/registered

API reference For AI assistants