A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis

NCT00324142 | Withdrawn Phase 2

• 1 other identifier: CN-06JGunt-01-B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks.

Conditions

Recurrent Bacterial Vaginosis

Keywords

Bacterial vaginosis; Tinidazole; Vaginitis

Outcome Measures

Primary Outcomes (2)

• Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis

• Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis

Secondary Outcomes (1)

• Patient satisfaction with tinidazole for recurrent bacterial vaginosis

Interventions

Oral tinidazole DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current infection with bacterial vaginosis
• previous episodes of bacterial vaginosis within the past 12 months
• Willing to use contraception
• Able to swallow pills
• Willing to refrain from douching or using vaginal products
• Willing to refrain from alcohol consumption 24 hours before and for 72 hours after taking study medication (tinidazole)

You may not qualify if:

• Women with same sex partners
• Menstruating at initial exam
• Presence of yeast, a sexually transmitted disease, or other vaginal infection
• Purulent cervical discharge
• Use of any drug for bacterial vaginosis or yeast within the past 2 weeks prior to enrollment
• Pregnant or nursing
• Taking lithium
• Taking blood thinners (anticoagulation therapy)
• Use of any investigational drug within the previous 30 days
• Active HPV infection requiring treatment
• Use of drugs that suppress the immune system
• History of alcoholism
• Taking disulfiram

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Vaginitis

Interventions

Tinidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Gunter, MD

  Kaiser Permamente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 10, 2006
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

US (1)