Background: Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by mucopurulent discharge from the cervix and other signs of inflammation. This was a phase III, multicenter study designed to evaluate the effectiveness of placebo versus empiric antibiotic treatment for clinical cure of MPC of unknown etiology at 2-month follow-up. Unfortunately, enrollment was terminated because of low accrual of women with cervicitis of unknown etiology, but important prevalence and outcome data were obtained.
Methods: Five hundred seventy-seven women were screened for MPC. Women with MPC were randomized to the treatment or placebo arm of the study, and the 2 arms were evaluated based on the etiology, clinical cure rates, adverse events (AEs), and rates of pelvic inflammatory disease.
Results: One hundred thirty-one (23% [131/577]) screened women were found to have MPC. Eighty-seven were enrolled and randomized. After excluding women with sexually transmitted infections and other exclusions, 61% (53/87) had cervicitis of unknown etiology. The overall clinical failure rate was 30% (10/33), and the clinical cure rate was only 24% (8/33). Rates were not significantly different between the arms. There were 24 gastrointestinal AEs in the treatment arm compared with 1 AE in the placebo arm.
Conclusions: More than half of the cases of MPC were of unknown etiology. Clinical cure rates for the placebo and treatment arms were extremely low, with most women concluding the study with a partial response. Gastrointestinal AEs were higher in the treatment arm.
Among women with mucopurulent cervicitis, the prevalence of mucopurulent cervicitis of unknown etiology was 61% and the rate of clinical cure was only 24%.
From the *Louisiana State University Health Sciences Center, New Orleans, LA; †University of Arkansas for Medical Sciences, Little Rock, AR; ‡University of Alabama at Birmingham, Birmingham, AL; §University of Mississippi, Jackson, MS; ∥Women’s Health Care Clinic/LA Biomedical Institute, Los Angeles, CA; and ¶FHI 360, Triangle Park, NC
The authors thank David H. Martin, MD; Edward Hook, III, MD; Christina Muzny, MD; Jill Stanton, BA; and Heather Craig, MPH, for their tremendous contributions and support for this project (DMID Protocol Number: 7-0082).
This clinical trial was funded by DMID/NIAID/National Institutes of Health contract number N01AI40073C through STICTG (DMID Protocol Number: 7-0082).
Conflict of interest: J.S. has received support from Combe and Medicis.
Correspondence: Stephanie N. Taylor, MD, Section of Infectious Diseases, Louisiana State University Health Sciences Center, 517 N Rampart St, New Orleans, LA 70112. E-mail: email@example.com.
Received for publication August 14, 2012; accepted November 19, 2012.