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Treatment of Bacterial Vaginosis With Oral Tinidazole

Information source: Mission Pharmacal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: Tinidazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mission Pharmacal

Summary

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

Clinical Details

Official title: A Phase III Randomized, Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Therapeutic efficacy

Safety

Secondary outcome:

Clinical efficacy

Microbiological efficacy

Detailed description: Tinidazole is a second-generation nitroimidazole i. e. an updated form of the standard drug used to treat bacterial vaginosis (metronidazole). Two dosing regimens are being compared to placebo to treat bacterial vaginosis, one of the most common vaginal infections.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria: Other sexually transmitted disease

-

Locations and Contacts

Duke University School of Medicine, Durham, North Carolina 27710, United States
Additional Information

Starting date: January 2005
Last updated: June 18, 2007

Page last updated: August 23, 2015

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