Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Bacterial Vaginosis Clinical Trial

Official title:

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510614
• Other study ID #: PRO07030019
• Status: Completed
• Phase: Phase 0
• First received: August 1, 2007
• Last updated: February 16, 2011
• Start date: October 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 18-45 at time of enrollment.

2. Recurrent BV as defined by:

• 2 previously documented diagnoses of BV in the past 6 months or

• 3 previously documented diagnoses of BV in the past year

3. Non-pregnant, non-lactating.

4. Premenopausal.

5. Presence of bacterial vaginosis at the enrollment visit using Amsel Criteria (at least 3 of 4):

• Presence of homogenous vaginal discharge

• pH of vaginal secretions of > 4.7

• Presence of a positive "whiff" test of the vaginal secretions upon mixing with 10% KOH

• Presence of > 20% clue cells on saline microscopy

6. Willingness to undergo randomization to a possible placebo arm (for suppressive therapy).

7. Ability to undergo informed consent.

8. Willingness to refrain from use of any intravaginal products (including douching, contraceptive spermicides, creams, gels, foams).

9. Currently using an acceptable method of birth control (such as a hormonal method including oral contraceptives, Depo Provera, Ortho Evra, abstinence x 60 days, consistent condom use, surgically sterile, lesbian orientation).

10. Willing to refrain from alcohol consumption during use of study medication and three days following completion of medication (which includes the 10 day open label treatment and the entire 3 month suppressive phase of treatment).

Exclusion Criteria:

1. Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.

2. Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).

3. Current use of any of the following medications: lithium, fluorouracil, anticonvulsant/seizure medications, Questran (cholestyramine) or CYP3A4 inducer/inhibitors (i.e. phenobarbital, rifampin, phenytoin, fosphenytoin).

4. Use of Antabuse (disulfiram) currently or within the past 2 weeks.

5. Allergy to metronidazole or tinidazole (related drugs with likely cross-over allergy potential).

6. Use of any antibiotics (oral or vaginal) in the past 7 days.

7. Current use of an IUD, Nuva Ring.

8. Known immunosuppressive condition (i.e. HIV, end-stage renal disease, currently-treated diabetes mellitus, etc.) or on immunosuppressive medications [i.e. steroids, cyclosporine, Protopic (tacrolimus), immunomodulators].

9. Participation in an investigational drug study within the past 30 days.

10. Any condition which in the opinion of the investigator would impose a health risk to the subject or interfere with the evaluation of the study medication or procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• tinidazole
1 gram twice weekly for 12 weeks
• Placebo
one pill twice weekly for 12 weeks

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Mission Pharmacal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.		at each study visit	No
Secondary	Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.		at each study visit	No