CompletedPhase 3

Randomized Controlled Trial of Treatment of Male Partners of Women With BV

United States214 participantsStarted 2015-02

Plain-language 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

Who can participate

Age range19 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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

What they're measuring

Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female

Timeframe: 16 weeks post start of receipt of study drug

Trial details

NCT IDNCT02209519

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03

Results submitted2020-03-27

View on ClinicalTrials.gov More Recurrent Bacterial Vaginosis trials