TY - JOUR
T1 - Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis
AU - StepUp Team
AU - Vodstrcil, Lenka A.
AU - Plummer, Erica L.
AU - Fairley, Christopher K.
AU - Hocking, Jane S.
AU - Law, Matthew G.
AU - Petoumenos, Kathy
AU - Bateson, Deborah
AU - Murray, Gerald L.
AU - Donovan, Basil
AU - Chow, Eric P.F.
AU - Chen, Marcus Y.
AU - Kaldor, John
AU - Bradshaw, Catriona S.
N1 - Publisher Copyright:
Copyright © 2025 Massachusetts Medical Society.
PY - 2025/3/6
Y1 - 2025/3/6
N2 - 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.).
AB - 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.).
UR - http://www.scopus.com/inward/record.url?scp=86000576832&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2405404
DO - 10.1056/NEJMoa2405404
M3 - Article
C2 - 40043236
AN - SCOPUS:86000576832
SN - 0028-4793
VL - 392
SP - 947
EP - 957
JO - The New England Journal of Medicine
JF - The New England Journal of Medicine
IS - 10
ER -