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Completed

NCT Number: NCT00334633

Treatment of Bacterial Vaginosis (BV) With Tinidazole

We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Jefferson County Department of Health STD Clinic

Birmingham, Alabama, 35294, United States

About this study

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:

  • 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
  • To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tinidazole, metronidazole

Drug

Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

Other names: Tindamax, Flagyl

Primary outcomes

  1. Cure of Bacterial Vaginosis

    Time frame: one month

    resolution of Amsel criteria for bacterial vaginosis

Secondary outcomes

  1. Recurrence of BV

    Time frame: baseline to 4 weeks

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Tinidazole for the Treatment of Bacterial Vaginosis

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2006
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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