Phase 3 N=214 Randomized Quadruple-blind Prevention

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

Recurrent Bacterial Vaginosis

Bottom Line

View on ClinicalTrials.gov: NCT02209519 ↗

Enrolled (actual)

214

Serious AEs

0.5%

Results posted

Apr 2020

Primary outcome: Primary: 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 — 87; 86 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Metronidazole (male partner) (Drug); Placeob (male partner) (Other)
Age: Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	87; 86	—
SECONDARY Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole	—	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02209519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.