NCT00229216

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

September 27, 2005

Last Update Submit

March 21, 2017

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (2)

  • Therapeutic efficacy

  • Safety

Secondary Outcomes (2)

  • Clinical efficacy

  • Microbiological efficacy

Interventions

TinidazoleDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and microbiological diagnosis of bacterial vaginosis -

You may not qualify if:

  • Other sexually transmitted disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Livengood CH 3rd, Ferris DG, Wiesenfeld HC, Hillier SL, Soper DE, Nyirjesy P, Marrazzo J, Chatwani A, Fine P, Sobel J, Taylor SN, Wood L, Kanalas JJ. Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):302-9. doi: 10.1097/01.AOG.0000275282.60506.3d.

    PMID: 17666604DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Tinidazole

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

January 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(1)