# A review of recommendations, efficacy, and patient safety for over-the-counter norgestrel for daily contraception

**Authors:** Gia Tran, Joshua Wollen, Shantera Davis, Elisabeth M. Wang, Julia Arriazola, Natalie Rosario

PMC · DOI: 10.1016/j.rcsop.2025.100591 · 2025-03-11

## TL;DR

This paper reviews the impact of making norgestrel, a progestin-only contraceptive, available over-the-counter in the U.S., focusing on its safety, effectiveness, and potential to improve contraceptive access.

## Contribution

The paper provides a comprehensive analysis of the implications of OTC norgestrel availability in the U.S., emphasizing its potential to reduce barriers to contraception.

## Key findings

- OTC access to norgestrel may significantly reduce barriers to contraception and improve public health outcomes.
- Progestin-only pills are generally safe and effective, with cervical mucus thickening providing contraception within 48 hours.
- Widespread education and proper use will be critical to realizing the full benefits of OTC norgestrel.

## Abstract

This narrative review examines the implications of norgestrel, a progestin-only oral contraceptive, becoming newly available over-the-counter (OTC) in the United States. The objectives are to explore the pharmacotherapy,mechanism of action, efficacy, safety, and implications to clinical practice of OTC progestin-only pills (POPs), and how this may impact contraceptive access and public health.

The review synthesizes data from clinical studies, public health reports, global perspectives, and recent policy changes to assess the potential impact of OTC access to norgestrel in the United States. The analysis includes the evaluation of the pharmacodynamics of norgestrel 0.075 mg on ovarian activity, the effectiveness of POPs, and benefits and barriers to contraceptive access.

The evidence indicates that POPs thickens cervical mucus, providing effective contraception within 48 h of use. While ovulation inhibition may take up to 28 days and occurs in approximately half of users, the availability of POPs OTC is anticipated to significantly reduce barriers to contraceptive access. This could lead to a broader use of effective contraception and potentially reduce unintended pregnancies. Additionally, the review highlights that the introduction of OTC contraceptives could increase access among populations historically facing difficulties in obtaining prescriptions.

Making norgestrel available OTC represents a critical advancement in contraceptive access with the potential to enhance public health by reducing unintended pregnancies. However, the extent of its impact will depend on widespread education and adherence to proper use. The review underscores the need for further research to monitor outcomes post-OTC availability and to assess the broader implications for reproductive health and equity.

•Many countries have hormonal contraceptives available without a prescription.•The US approved over-the-counter norgestrel, a progestin only contraceptive.•Access to contraceptives can improve childbearing individuals' quality of life.•Progestin only contraceptives are generally safe and efficacious.

Many countries have hormonal contraceptives available without a prescription.

The US approved over-the-counter norgestrel, a progestin only contraceptive.

Access to contraceptives can improve childbearing individuals' quality of life.

Progestin only contraceptives are generally safe and efficacious.

## Linked entities

- **Chemicals:** norgestrel (PubChem CID 4542)

## Full-text entities

- **Species:** Homo sapiens (human, species) [taxon 9606]

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Source: https://tomesphere.com/paper/PMC11957599