Baseline colposcopic findings in women entering studies on female vaginal products

Abstract

Background Colposcopy is commonly used for genital tract assessment in safety studies on female-controlled vaginal products. However, findings that are considered “lesions” are present even without product use. We sought to categorize the type and frequency of lesions found on baseline colposcopy evaluation in healthy women to describe natural lower genital tract changes due to environmental factors. Study Design We reviewed demographic information and baseline colposcopic examination findings from subjects in 13 studies of vaginal products. All studies included an aim of identifying colposcopic changes as a means of monitoring safety of a vaginal product or device. Colposcopic evaluations were performed according to the WHO/CONRAD Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products. Results A total of 317 lesions were found on 569 baseline colposcopy evaluations, with 192 women (34%) having at least one lesion. The most commonly identified lesions were petechiae and erythema, accounting for 45% and 37% of lesions, respectively. Seventy-three percent of lesions were located on the cervix, whereas 15% of lesions were located on the vaginal wall or fornix. Conclusions Lower genital tract colposcopic findings are common in healthy women. Such findings likely represent normal physiologic changes. Future research needs to address whether routine colposcopic examination is necessary in the evaluation of new vaginal products.