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Abstract
Background Efforts are underway to make a progestin-only pill (POP) over the counter (OTC) in the United States (US); however, little is known about POP user experiences, which could impact uptake and continuation.
Methods From January 2020–September 2021, we conducted a cross-sectional online survey with individuals who used OTC POPs in a US trial. We calculated descriptive statistics and Pearson chi-square and Fisher’s exact tests to assess menstrual bleeding acceptability, how OTC POP experiences compared with prior contraceptive methods, and preferred ways to get answers to questions during OTC POP use.
Results Among 550 adult and 115 adolescent participants, 80% (n=531) felt their menstrual bleeding was acceptable. Participants reported a range of menstrual bleeding experiences compared with prior long-acting or hormonal methods used; 58% (n=84) said the POP bleeding was similar or better and 36% (n=53) said it was worse. Among participants who used contraception in the month prior to the trial, 77% (n=201) said their overall OTC POP experience was similar or better. Top benefits compared with prior methods included less worry about pregnancy, ease of access, fewer side effects, and greater decision-making power. Adults preferred to get answers about OTC POPs via webpage or app, whereas teens preferred asking pharmacists or other healthcare providers.
Conclusions Overall, OTC POP users in a trial setting found the menstrual bleeding acceptable and the method similar to or better than previous methods. POP labelling should provide clear messaging about bleeding changes users may experience.
- Contraceptive Agents, Female
- contraceptives, oral
- family planning policy
- Health Policy
- hormonal contraception
- Reproductive Health
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Statistics from Altmetric.com
- Contraceptive Agents, Female
- contraceptives, oral
- family planning policy
- Health Policy
- hormonal contraception
- Reproductive Health
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Footnotes
Twitter @DrDGrossman
Contributors KG: conceptualisation, methodology, formal analysis, writing - original draft, writing - review and editing, supervision, project administration, funding acquisition, guarantor. KK: formal analysis, writing - review and editing. CZ: formal analysis, writing - review and editing, supervision, project administration. AW: conceptualisation, writing - review and editing. DG: conceptualisation, writing - review and editing. KB: conceptualisation, writing - review and editing, funding acquisition.
Funding This research was made possible with support from Arnold Ventures, the Collaborative for Gender + Reproductive Equity, and The David and Lucile Packard Foundation. The funders had no involvement in the study design; collection, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication.
Competing interests Ibis Reproductive Health, where all study authors have an affiliation, has a partnership with HRA Pharma in which Ibis Reproductive Health provided financial support for some of the research that will be part of the over-the-counter switch application to the US Food and Drug Administration for a progestin-only pill. Ibis Reproductive Health receives no monetary compensation nor ownership of any rights to the product. Ibis Reproductive Health raised the funding for this partnership from a private foundation and selected HRA Pharma as its partner through an open process overseen by the Oral Contraceptives Over-the-Counter Working Group steering committee in an effort to incentivise a pharmaceutical company to complete the work to make a birth control pill available over the counter.
Patient and public involvement The study topic was identified as a priority at meetings of the Oral Contraceptives Over-the-Counter Working Group, a coalition of reproductive health, rights and justice organizations, researchers, youth activists and clinicians who represent and/or work closely with populations that could benefit from over-the-counter oral contraception access. Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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