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Sponsors and Collaborators: |
University of Pittsburgh Mission Pharmacal |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00510614 |
This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV).
This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment.
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.
Condition | Intervention | Phase |
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Bacterial Vaginosis |
Drug: tinidazole Drug: Placebo |
Phase 0 |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
1 gram tinidazole twice weekly for 12 weeks
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Drug: tinidazole
1 gram twice weekly for 12 weeks
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B: Placebo Comparator
Placebo twice weekly for 12 weeks
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Drug: Placebo
one pill twice weekly for 12 weeks
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recurrent BV as defined by:
Presence of bacterial vaginosis at the enrollment visit using Amsel Criteria (at least 3 of 4):
Exclusion Criteria:
Contact: Ingrid S Macio, PA-C | 412-641-4242 | imacio@mail.magee.edu |
Contact: Jamie Haggerty, BA | 412-641-4242 | jhaggerty@mail.magee.edu |
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Richard Beigi, MD, MSc. |
Principal Investigator: | Richard Beigi, MD, MSc. | Magee-Womens Hospital of UPMC |
Responsible Party: | University of Pittsburgh ( Richard H Beigi, MD ) |
Study ID Numbers: | PRO07030019 |
Study First Received: | August 1, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00510614 |
Health Authority: | United States: Institutional Review Board |
Bacterial Vaginosis Recurrent Bacterial Vaginosis |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis |
Vaginal Diseases Recurrence Tinidazole |
Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Antitrichomonal Agents Alkylating Agents Pharmacologic Actions |