Randomized Controlled Trial of Treatment of Male Partners of Women With BV (NCT02209519) | Clinical Trial Compass
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 range
19 Years – 50 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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