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Treatment of Bacterial Vaginosis (BV) With Tinidazole

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ClinicalTrials.gov Identifier: NCT00334633
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : June 23, 2011
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: tinidazole, metronidazole Phase 4

Detailed Description:

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.

The specific aims of this project are:

  1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
  2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
  3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tinidazole for the Treatment of Bacterial Vaginosis
Study Start Date : November 2004
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: control
metronidazole 500 BID for 7 days
Drug: tinidazole, metronidazole
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Other Name: Tindamax, Flagyl
Active Comparator: tinidazole 500
tinidazole 500 BID for 7 days
Drug: tinidazole, metronidazole
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Other Name: Tindamax, Flagyl
Active Comparator: tinidazole 1 gm
tinidazole 1 gm BID for 7 days
Drug: tinidazole, metronidazole
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Other Name: Tindamax, Flagyl


Outcome Measures

Primary Outcome Measures :
  1. Cure of Bacterial Vaginosis [ Time Frame: one month ]
    resolution of Amsel criteria for bacterial vaginosis


Secondary Outcome Measures :
  1. Recurrence of BV [ Time Frame: baseline to 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women be at least 18 years of age
  • Have symptoms of vaginal odor and or/discharge
  • Meet the clinical (Amsel) criteria for BV
  • Willing to participate in research

Exclusion Criteria:

  • Presence of another vaginal infection or STD
  • Allergy to metronidazole
  • Pregnant or nursing
  • Use of oral or intravaginal antibiotics within the past 2 weeks
  • HIV or other chronic disease
  • Inability to keep return appointments
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334633


Locations
United States, Alabama
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Jane Schwebke, MD University of Alabama at Birmingham
More Information

Responsible Party: Jane Schwebke, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00334633     History of Changes
Other Study ID Numbers: F040329003
R01AI058033 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2006    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: December 1, 2017
Last Verified: October 2017

Keywords provided by Jane Schwebke, University of Alabama at Birmingham:
bacterial vaginosis
tinidazole

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