Abstract
Objectives: Progestin-only pills (POPs) prevent pregnancy through a combination of mechanisms including ovarian suppression and cervical mucus changes. In this study, we sought to evaluate the potential contraceptive efficacy of a norgestrel 75 mcg POP based on cervical mucus and ovulatory effect changes during a 28 day cycle.
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
Current approaches rely on imaging studies or invasive exploratory exams to confirm a copper intrauterine device (Cu-IUD) when strings are missing. Our study objective was to determine whether Cu levels in cervical mucus could be used to discriminate between Cu-IUD users and nonusers. We collected cervical mucus at any time in the menstrual cycle as well as subject and Cu-IUD usage characteristics. Using inductively coupled plasma mass spectrometry (ICPMS), we determined the concentration of Cu in cervical mucus samples and compared Cu levels between Cu-IUD users and non-users. We found higher Cu levels in the cervical mucus of Cu-IUD users compared to nonusers (mean Cu concentration 2.80 μg/g vs 0.33 μg/g, p
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