Publications by authors named "Alison B Edelman"

Objective: To determine the cost effectiveness of a policy change making a progestin-only contraceptive pill available over-the-counter (OTC).

Methods: We created a decision analytic model to determine the cost effectiveness of making an OTC progestin-only contraceptive pill available in the United States in two distinct policy environments: one in which abortion is legal and available and one in which abortion is restricted. Our theoretical population included 1,000,000 women at risk of unintended pregnancy over 1 year.

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Importance: The US Food and Drug Administration approved the first over-the-counter (OTC) oral contraceptive pill (OCP) in 2023, potentially expanding access to contraception. Understanding whether OTC availability reaches individuals with systemic barriers to care is essential to assessing its public health impact.

Objective: To evaluate whether the newly available OTC progestin-only OCP is reaching individuals not previously using contraception or who rely on less-effective methods.

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Through the examination of scientific evidence related to human embryo development, the aim of this commentary is to support the right to science in sexual and reproductive health, to outline why science supports a legal approach to embryos as the biological material of human life but not as human persons, and to recognise that international human rights law adopts this approach in the protection of sexual and reproductive health and rights.

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Objectives: To understand how changes to in-person health care during the COVID pandemic impacted contraceptive use in Oregon's state-funded network.

Study Design: A retrospective cohort of 245,600 visits (virtual and in-person) among 70,295 women presenting to publicly funded family planning clinics in Oregon between January 2019 and June 2021. Data were abstracted from clinic records and restricted to visits of patients identifying as female, 12-51 years old, not using sterilization as a method.

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Objective: To assess whether dose escalation (ie, doubling the dose) of emergency contraception that contains levonorgestrel (LNG) improves pharmacodynamic outcomes in individuals with obesity.

Methods: We enrolled healthy, reproductive-age individuals with regular menstrual cycles, body mass index (BMI) higher than 30, and weight at least 176 lbs in a randomized pharmacodynamic study. After confirming ovulation (luteal progesterone level greater than 3 ng/mL), we monitored participants with transvaginal ultrasonography and blood sampling for progesterone, luteinizing hormone, and estradiol every other day until a dominant follicle measuring 15 mm or greater was visualized.

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Background: States have passed legislation to expand the scope of pharmacists to directly prescribe contraception. It is thought that pharmacist prescription of contraception may promote correct and consistent use of contraception by reducing barriers to access. However, it is not known how this may impact ongoing contraceptive use.

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Objective: Expanding access to medical abortion through pharmacies is a potential strategy to promote safe abortion care. To compare the effectiveness and safety of medical abortion offered in pharmacy settings with clinic-based medical abortion.

Study Design: We searched multiple databases and the gray literature through November 2020.

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Background: Although heavy menstrual bleeding (HMB) is a known complication of anticoagulant therapy, rates of HMB in users of the direct oral anticoagulants (OACs) apixaban and rivaroxaban are largely unknown.

Methods: We performed a retrospective cohort study of menstruating women prescribed rivaroxaban, apixaban and warfarin over a six-year period (2012-2018). The primary outcome was HMB requiring medical or surgical intervention.

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Background: Postpartum hemorrhage is a leading cause of maternal mortality globally. A tamponade agent that can be quickly and easily placed in a range of settings could advance the treatment of atonic hemorrhage.

Method: We adapted a highly effective trauma dressing for use in postpartum hemorrhage.

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Objective: To develop a method to simultaneously quantify the synthetic contraceptive progestin segesterone acetate (Nestorone®, NES) and the endogenous steroid hormones estradiol (E2), progesterone (P4), and estrone (E1) in human serum samples by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Study Design: We analyzed 615 serum samples collected from 67 reproductive-age women actively using a contraceptive vaginal ring (CVR) designed to release NES (200 mcg/d) and E2 (75-200 mcg/d). Samples were taken prior to and up to 30 days after CVR insertion and analyzed for concentrations of NES, E2, P4, and E1 in human serum using a Shimadzu Nexera-LCMS-8050 LC-MS/MS platform.

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Objective: To evaluate whether a short course of tamoxifen decreases bothersome bleeding in etonogestrel contraceptive implant users.

Methods: In a 90-day, double-blind randomized control trial, we enrolled etonogestrel implant users with frequent or prolonged bleeding or spotting. A sample size of 40 per group (N=80) was planned to compare 10 mg tamoxifen or placebo twice daily for 7 days after 3 consecutive days of bleeding or spotting no more than once per 30 days (maximum three treatments).

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Objective: To describe reasons for and experiences with obtaining contraception from pharmacists.

Study Design: Cross-sectional survey.

Results: Our sample included 426 women presenting for hormonal contraception (n = 150 pharmacist prescribers).

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Importance: Since 2016, 11 states have expanded the scope of pharmacists to include direct prescription of hormonal contraception. Dispensing greater than 1 month's supply is associated with improved contraceptive continuation rates and fewer breaks in coverage. Scant data exist on the practice of pharmacist prescription of contraception and its outcomes compared with traditional, clinic-based prescriptions.

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Objective: To estimate the effect of oral opioids on patient pain during first-trimester medical abortion.

Methods: We conducted a randomized, double-blind, placebo-controlled trial where patients up to 10 0/7 weeks of gestation undergoing a medical abortion with mifepristone and misoprostol took 10 mg oral oxycodone or placebo at onset of painful cramping. Additionally, all patients received 800-mg ibuprofen tablets, 4-mg ondansetron oral dissolving tablets, and a written prescription for adjunctive pain medication (six tablets oxycodone 5 mg).

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Objective: To determine if a course of oral tamoxifen initiated following placement of a levonorgestrel 52-mg intrauterine system (IUS) reduces bleeding/spotting days over 30 days.

Study Design: In this single-center, double-blind, placebo-controlled trial, we recruited women ages 15-45 years initiating the levonorgestrel 52-mg IUS. We randomized eligible women to tamoxifen 10 mg or placebo twice daily for 7 days starting 21 days after levonorgestrel 52-mg IUS insertion.

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Objective: To estimate unintended pregnancies averted and the cost effectiveness of pharmacist prescription of hormonal contraception.

Methods: A decision-analytic model was developed to determine the cost effectiveness of expanding the scope of pharmacists to prescribe hormonal contraception compared with the standard of care and contraceptive access in clinics. Our perspective was that of the payor, Oregon Medicaid.

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Objective: To estimate the cost-effectiveness of ulipristal acetate (UPA) and levonorgestrel (LNG) emergency contraception (EC) on pregnancy prevention among combined oral contraceptive (COC) pill users with an extended pill-free interval. We accounted for the potential interaction of COCs and obesity on EC efficacy.

Methods: We built a decision-analytic model using TreeAge software to evaluate the optimal oral EC strategy in a hypothetical cohort of 100,000 twenty-five-year-old women midcycle with a prolonged "missed" pill episode (8-14 days).

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Background: In 2016, Oregon became the first of eight states to allow pharmacists to directly prescribe hormonal contraception (HC), including the pill, patch, or ring, without a clinic visit. In the two years following this policy change, the majority of ZIP codes across the state of Oregon had a pharmacist certified to prescribe HC.

Methods: We will utilize complementary methodologies to evaluate the effect of this policy change on convenient access to contraception (cost, supply dispensed), safety, contraceptive continuation and unintended pregnancy rates.

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Objective: The objective was to evaluate the pharmacokinetics (PKs) of levonorgestrel (LNG)-containing combined oral contraceptives (COCs) in obese women.

Study Design: We pooled and reanalyzed data from 89 women with different body mass index (BMI) categories from four clinical studies. The LNG and ethinyl estradiol (EE) PKs were analyzed utilizing a zero-order absorption (K), two-compartment PK model to evaluate key PK parameters in relation to a range of weights, BMI and body surface area (BSA).

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