University of Oklahoma Health Sciences Center

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Author/s:

Lenka A Vodstrcil, Erica L Plummer, Christopher K Fairley, Jane S Hocking, Matthew G Law, Kathy Petoumenos, Deborah Bateson, Gerald L Murray, Basil Donovan, Eric P F Chow, Marcus Y Chen, John Kaldor, Catriona S Bradshaw, StepUp Team

Date Added:

March 10, 2025

Journal/Publication:

New England Journal of Medicine

Publisher:

Massachusetts Medical Society

Publication Date:

March 6, 2025

Issue:

Volume:

392

Pages:

947-957

URL:

Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa2405404

PMID (1):

40043236

Keywords

vaginosis

bacterial vaginosis

bacterial imbalance

reproductive-aged women

MeSH

Anti-Infective Agents

anti-bacterial agents

RPR Commentary

Treatment of male sexual partners can reduce reoccurrence of bacterial vaginosis in women. James W. Mold, MD, MPH

Abstract

Background
Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis–associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure.

Methods
This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks.

Results
A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of −2.6 recurrences per person-year (95% CI, −4.0 to −1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.

Conclusions
The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care. (Funded by the National Health and Medical Research Council of Australia; StepUp Australian New Zealand Clinical Trials Registry number, ACTRN12619000196145.)

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