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Trial question
What is the role of addition of combined oral and topical antimicrobial therapy in male partners to prevent recurrence of bacterial vaginosis in women?
Study design
Multi-center
Open label
RCT
Population
159 patients (undefined female, 159 male).
Inclusion criteria: couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner.
Key exclusion criteria: current sex worker; concurrent sexual partners; HIV-positive.
Interventions
N=80 male partner treatment (receipt of first-line recommended antimicrobial agents for woman and receipt of oral metronidazole 400 mg BID and 2% clindamycin cream applied to penile skin BID for 7 days for male partner).
N=79 usual care (receipt of first-line antimicrobial agents for woman and no treatment for male partner).
Primary outcome
Rate of recurrence of bacterial vaginosis in women within 12 weeks
35%
63%
63.0 %
47.3 %
31.5 %
15.8 %
0.0 %
Male partner
treatment
Usual
care
Significant
decrease ▼
NNT = 3
Significant decrease in the rate of recurrence of bacterial vaginosis in women within 12 weeks (35% vs. 63%; HR 0.37, 95% CI 0.22 to 0.61).
Secondary outcomes
Significant decrease in the rate of bacterial vaginosis recurrence, 3-4 Amsel criteria and Nugent score 4-10 within 4 weeks (17.4% vs. 45.6%; HR 0.31, 95% CI 0.16 to 0.59).
Significant decrease in the rate of bacterial vaginosis recurrence, Nugent score 7-10 within 12 weeks (37.7% vs. 57.4%; HR 0.46, 95% CI 0.28 to 0.76).
Significant decrease in missing data imputed as cure (30% vs. 56%; HR 0.39, 95% CI 0.24 to 0.64).
Safety outcomes
No significant difference in adverse effects in women.
Conclusion
In couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner, male partner treatment was superior to usual care with respect to the rate of recurrence of bacterial vaginosis in women within 12 weeks.
Reference
Lenka A Vodstrcil, Erica L Plummer, Christopher K Fairley et al. Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis. N Engl J Med. 2025 Mar 6;392(10):947-957.
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