Phase 3
Completed N=214
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Recurrent Bacterial Vaginosis
Source: ClinicalTrials.gov NCT02209519 ↗
Enrolled (actual)
214
Serious AEs
0.5%
Results posted
Apr 2020
Primary outcomePrimary: 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
◆ Published Evidence
Established
47citations · ~9 / year
Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial.
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
Linked Publications
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Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial.
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 |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02209519) and the linked publication. 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. Informational only — not medical advice.