Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(Study Terminated Prematurely)
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00324142
First received: May 9, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Bacterial Vaginosis
Drug: Oral tinidazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
  • Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis

Secondary Outcome Measures:
  • Patient satisfaction with tinidazole for recurrent bacterial vaginosis

Enrollment: 0
Detailed Description:

This study will recruit 60 women with recurrent bacterial vaginosis. These women must have a current infection to be enrolled in the study and have had two other infections within the past 12 months. After initial screening to make sure that the vaginal symptoms are due to bacterial vaginosis and not the results of a different infection, all of the women will receive tinidazole (a drug that is similar to metronidazole) by mouth for 10 days. At the end of the 10 days, patients will be re-examined. Those women who are free of bacterial vaginosis will enter the second phase of the study, where half of the patients will continue to take tinidazole twice a week for twelve weeks and the other half will take no medication. During this time participants will be examined by the study doctor every 4 weeks to see how effective the treatment has been at preventing the recurrence of bacterial vaginosis. At the end of the 12 weeks, women who are still free of bacterial vaginosis will be seen for 3 more visits over 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current infection with bacterial vaginosis
  • 2 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324142

Locations
United States, California
Kaiser Permanente
San Francisco, California, United States, 94115
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Jennifer Gunter, MD Kaiser Permamente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00324142     History of Changes
Other Study ID Numbers: CN-06JGunt-01-B
Study First Received: May 9, 2006
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaiser Permanente:
Bacterial vaginosis
Tinidazole
Vaginitis

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis
Tinidazole
Alkylating Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014