Abstract
Objectives: With a panel of experts, we developed a prototype over-the-counter (OTC) Drug Facts Label (DFL) for a combined oral contraception (COC) 0.1mg levonorgestrel/0.02mg ethinyl estradiol pill. The objective of this pilot label comprehension study was to evaluate understanding of our primary communication messages.
Highlights
With a panel of experts, we developed a prototype over-the-counter (OTC) Drug Facts Label (DFL) for a combined oral contraception (COC) 0.1mg levonorgestrel/0.02mg ethinyl estradiol pill
Eleven primary communication messages were developed based on an assessment of the clinical risks that are likely if consumers fail to heed key communication messages on the DFL, and included those that, if not heeded, represent the greatest potential for clinical consequence to consumers
After reading the prototype OTC COC label, 10 of the 11 primary communication messages were each understood by ≥95% of participants, and the remaining message was understood by 88% of participants; 99% of participants correctly understood what the product was used for
Summary
The Vaginal pH Modulator (VPM; Phexxi R ) was recently approved for prevention of pregnancy for use as an on-demand method of contraception. The objectives of the current analysis are to present self-reported GU symptoms by frequency of use of VPM. Incidents of GU symptoms, including vaginal burning, itching, pain, discharge or odor, were reported by women via their daily eDiary and at the time they recorded product use and vaginal intercourse. Over the course of the study, most women used the product once or twice per day (50.5% [674/1,335] and 41.3% [551/1,335], respectively). There were an average of 4.9 study days with product use per cycle. GU symptoms were reported in 3.7% (1,263/34,117) of days with recorded product use. Conclusions: Women did not report/experience GU symptoms on the vast majority of days of VPM use, regardless of the frequency of use.
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