Treatment of Bacterial Vaginosis With Oral Tinidazole

Bacterial Vaginosis Clinical Trial

Official title:

A Phase III Randomized, Multi-center, Double-blind, Double-dummy, Placebo-controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229216
• Other study ID #: T-500
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: March 21, 2017
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: March 2017
• Source: Mission Pharmacal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria:

Other sexually transmitted disease

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Tinidazole

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mission Pharmacal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic efficacy
Primary	Safety
Secondary	Clinical efficacy
Secondary	Microbiological efficacy