The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study

Glasier, Anna; Edelman, Alison; Creinin, Mitchell D.; Brache, Vivian; Westhoff, Carolyn; Han, Leo; Chen, Melissa J.; Hemon, Agnes

doi:10.1016/j.contraception.2022.09.002

Cited by 10 publications

(5 citation statements)

References 15 publications

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“…The label information for the norgestrel 75 μg pill instructs users to use a nonhormonal backup method of contraception for 48 h if a dose is missed or taken more than three hours late, noting it can take 2 days for the pill to start working again after a late or missed dose [23]. This recommendation assumes the primary mechanism of action of this pill is thickening cervical mucus and is based on data from a very small 1968 study indicating cervical mucus returned to normal within 22–24 h after ingestion of the progestin megestrol acetate; however, limited recent data indicate this recommendation may be overly conservative [18 ▪ ,21 ▪ ,30 ▪▪ ], and further research on this topic is needed.…”

Section: Norgestrel and Other Progestin-only Pillsmentioning

confidence: 99%

Over-the-counter access to hormonal contraception: a global perspective

Otto,

Klein,

Lau

et al. 2024

Current Opinion in Pediatrics

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Purpose of review Oral contraceptive pills are among the most popular contraceptives worldwide, including among adolescents, and are available over the counter in over 100 countries. However, when a prescription is required, oral contraceptives may be difficult to obtain, particularly for adolescents. Recent approvals of over-the-counter progestin-only pills in the United Kingdom and United States have brought widespread attention to this topic. Recent findings Progestin-only pills, including the norgestrel pill recently approved for over-the-counter use in the United States, are highly effective and may be used safely without a prescription or medical monitoring, including by adolescents. These pills are associated with relatively high user satisfaction. Although over-the-counter availability may improve contraceptive access overall, issues related to insurance coverage and out-of-pocket cost may continue to pose practical barriers to access for many individuals. Summary Over-the-counter oral contraceptives are an appropriate and important contraceptive option for many adolescents. Over-the-counter availability has the potential to increase access to safe and effective contraception in the United States, United Kingdom, and other countries where a prescription is currently required. Future research on use patterns among adolescents is needed, as are advocacy efforts and policies to ensure access and affordability.

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Section: Norgestrel and Other Progestin-only Pillsmentioning

confidence: 99%

Over-the-counter access to hormonal contraception: a global perspective

Otto,

Klein,

Lau

et al. 2024

Current Opinion in Pediatrics

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“…7 Indeed, a recent small study of the norgestrel pill in which participants deliberately missed 1 day or delayed taking their pill by 6 hours showed that there was little effect on cervical mucus scores. 12 Thus, more research needs to be done and, as is evidenced by the much longer bioavailability of the drospirenone-containing progestin-only pill, not all progestin-only pills are the same when it comes to what constitutes a delayed or missed dose. 13…”

Section: Although It Is Widely Believed That Progestin-only Pillsmentioning

confidence: 99%

Opill

Allen,

Bartz

2023

Obstetrics &Amp; Gynecology

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The U.S. Food and Drug Administration has approved the first oral contraceptive pill (OCP) for over-the-counter status. This progestin-only pill contains norgestrel 0.075 mg taken daily, with a Pearl Index estimated at 4.4 (95% CI, 1.9–8.8). This formulation has an excellent safety profile, with current breast cancer as the only absolute contraindication and few relative contraindications. Ultimately, this approval has great potential to improve the accessibility of effective contraception for many pregnancy-capable Americans, especially those who have poor access to the health care system for prescription-required contraception, most notably people who hold marginalized identities. The pill’s overall success in reducing rates of unintended pregnancy will rely on its availability, particularly in rural communities that may rely on one pharmacy, and affordability, especially for uninsured or underinsured individuals. However, given the need for improved contraceptive provision, particularly in abortion-restrictive settings, the over-the-counter approval of this daily OCP is a major advancement in the nation’s contraceptive ecosystem.

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“…The remaining 3 participants ovulated and had intermediate mucus scores; ultimately, these participants were considered to have medium protection against pregnancy. 7,8 (See the contraceptive protection algorithm [TABLE, page E13]). 8 In the second and third cycles, the investigators evaluated ovulation and cervical mucus changes in the setting of either a delayed (by 6 hours) or missed dose midcycle.…”

Section: Norgestrel's Mechanism Of Action On Ovarian Activity and Cer...mentioning

confidence: 99%

“…7,8 (See the contraceptive protection algorithm [TABLE, page E13]). 8 In the second and third cycles, the investigators evaluated ovulation and cervical mucus changes in the setting of either a delayed (by 6 hours) or missed dose midcycle. 8 Of the 46 participants with evaluable data during the intervention cycles, 32 (70%) did not ovulate in each of the delayed-and missed-dose cycles.…”

Section: Norgestrel's Mechanism Of Action On Ovarian Activity and Cer...mentioning

confidence: 99%

“…8 In the second and third cycles, the investigators evaluated ovulation and cervical mucus changes in the setting of either a delayed (by 6 hours) or missed dose midcycle. 8 Of the 46 participants with evaluable data during the intervention cycles, 32 (70%) did not ovulate in each of the delayed-and missed-dose cycles. Most participants (n = 27; 59%) also demonstrated unfavorable mucus scores (modified Insler score ≤4) over the entire cycle despite delaying or missing a pill.…”

Section: Norgestrel's Mechanism Of Action On Ovarian Activity and Cer...mentioning

confidence: 99%

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