Status:
COMPLETED
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Wayne State University
Conditions:
Recurrent Bacterial Vaginosis
Eligibility:
All Genders
19-50 years
Phase:
PHASE3
Brief Summary
Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women
Detailed Description
This study will be performed as a phase III randomized, double-blinded trial to evaluate the efficacy of 1) metronidazole 500 mg PO BID for 7 days versus 2) placebo capsules alone for treatment of the...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Female
- At least 18 years of age (19 years of age in Alabama due to State law)
- Sexual partner to a female who meets study eligibility
- Willingness to provide informed consent
- Willingness to abstain from sexual intercourse or use condoms {during the study}
- Willingness to abstain from alcohol for the first week of the study
- Inclusion Criteria: Male
- At least 18 years of age (19 years of age in Alabama due to State law)
- Heterosexual with a regular partner
- History of 2 or more episodes of BV in the previous 12 months
- Symptoms of BV including vaginal discharge and/or odor
- Positive Amsel criteria for BV including vaginal pH \>4.5, positive whiff test, presence of clue cells
- Willingness to provide informed consent
- Willingness to abstain from sexual intercourse or use condoms {during the study}
- Willingness to abstain from alcohol for the first week of the study
- Exclusion criteria (both genders)
- Allergy to metronidazole
- Failure of the male partner to keep his appointment to be seen within 48 hours
- Pregnant or breast feeding (females)
- HIV or other chronic disease which in the opinion of the investigator would interfere with the ability to participate in this study
- Subject requires concurrent lithium, coumadin, dilantin, or antabuse
- Presence of trichomonas on wet prep of vaginal fluid (females)
- Women with a history of recurrent BV for \>3 years or women who have failed previous treatment studies for BV
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT02209519
Start Date
February 1 2015
End Date
March 1 2019
Last Update
April 27 2020
Active Locations (1)
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1
Jane Schwebke
Pell City, Alabama, United States, 35128