Treatment of Bacterial Vaginosis (BV) With Tinidazole

This study has been completed.

Study NCT00334633 Information provided by University of Alabama at Birmingham

First Received on June 7, 2006. Last Updated on May 24, 2011 History of Changes

Results First Received: March 3, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bacterial Vaginosis
Intervention:	Drug: tinidazole, metronidazole

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
women attending an STD clinic with symptomatic BV

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Metronidazole	metronidazole 500 BID for 7 days; 197 participants
Tinidazole 500 mg	tinidazole 500 BID for 7 days; 200 particpants
Tinidazole 1 gm	tinidazole 1 gm BID for 7 days; 196 particpants

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Metronidazole	metronidazole 500 BID for 7 days; 197 participants
Tinidazole 500 mg	tinidazole 500 BID for 7 days; 200 particpants
Tinidazole 1 gm	tinidazole 1 gm BID for 7 days; 196 particpants

Baseline Measures

	Metronidazole	Tinidazole 500 mg	Tinidazole 1 gm	Total
Number of Participants [units: participants]	197	200	196	593
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	197	200	196	593
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	28 ± 6.2	28.3 ± 6.6	28.5 ± 6.8	28.3 ± 6.7
Gender [units: participants]
Female	197	200	196	593
Male	0	0	0	0
Region of Enrollment [units: participants]
United States	197	200	196	593

Outcome Measures

1. Primary:

Cure of Bacterial Vaginosis [ Time Frame: one month ]

Show Outcome Measure 1

2. Secondary:

Recurrence of BV [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: jane R Schwebke, MD
Organization: University of Alabama at Birmingham
phone: 205-975-5665
e-mail: schwebke@uab.edu

No publications provided

Responsible Party:	Jane Schwebke , MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00334633 History of Changes
Other Study ID Numbers:	F040329003, R01AI058033
Study First Received:	June 7, 2006
Results First Received:	March 3, 2011
Last Updated:	May 24, 2011
Health Authority:	United States: Federal Government