Evaluation of adherence to a daily progestin-only pill in a simulated over-the-counter setting.

Objective: The Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study assessed whether consumers can adhere to the regimen for a progestin-only pill (norgestrel 0.075 mg) in an over-the-counter (OTC) setting.

Study Design: An actual use study in a simulated OTC environment assessed adherence to directions to take norgestrel 0.

Evaluation of consumer self-selection of a proposed over-the-counter, progestin-only daily oral contraceptive.

Objectives: In an effort to switch a norgestrel 0.075 mg progestin-only pill (Opill) from prescription to over-the-counter, we conducted this study to assess whether consumers can use the drug facts label alone to guide appropriate self-selection.

Study Design: Two studies assessed self-selection: (1) an all-comers, actual-use study evaluating self-selection before purchasing and using norgestrel 0.

Modeling the potential benefit of an over-the-counter progestin-only pill in preventing unintended pregnancies in the U.S.

Objectives: To develop a model to estimate the possible impact of use of an over-the-counter (OTC) progestin-only pill (POP) on the number of unintended pregnancies in the United States.

Study Design: Using typical use failure rates (7% for POPs), we compared the expected number of unintended pregnancies for two theoretical cohorts of 100,000 women: one which purchased and used an OTC POP exclusively for contraception, the other using contraceptive methods at proportions obtained from an actual-use clinical trial simulating OTC use of norgestrel 0.075 mg (including 35% using no method and only 19% using hormonal contraception or long-acting contraceptives).

The views of women and pharmacists on the desirability of a progestogen-only pill over the counter. Results of a survey in Germany, Italy and Spain.

Purpose: To explore the perceived need and enthusiasm for over the counter (OTC) progestogen-only pills (POP).

Materials And Methods: A web-based survey of 1000 sexually active women (16-45) and 100 pharmacists in Germany, Italy and Spain.

Results: Despite not wanting to conceive, 5-6% of women in each country were not using contraception and 8-20% were using methods less effective than condoms.

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

Objectives: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill.

Study Design: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.

Adherence among a cohort taking progestin-only pills prescribed by a healthcare provider: Results of the BENCHMARK study.

Objectives: To measure adherence over six months of progestin-only pill (POP) use.

Study Design: Prospective observational cohort study measuring adherence to daily dosing and timing of dose in patients prescribed a POP, with up to six months of follow-up, conducted from January to October 2020. A pharmacy benefit manager identified potential participants with a newly prescribed POP and extended an invitation to participate.

Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception.

Objective: To evaluate the cervical mucus effects of a norgestrel 0.075 mg progestin-only contraceptive pill over a 28-day cycle.

Study Design: We recruited persons ages 18 to 35 with normal cycles at 2 US academic medical centers.

Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity.

Objective: To explore the effect on ovarian activity and ovulation of 28 days of correct daily use of a progestogen-only pill containing norgestrel 0.075 mg.

Study Design: We performed a prospective, randomized, crossover study at 2 US sites, recruiting healthy women of reproductive age to use norgestrel 0.

Improving effective contraception uptake through provision of bridging contraception within community pharmacies: findings from the Bridge-it Study process evaluation.

Objective: To present process evaluation results from the Bridge-it Study, a pragmatic cluster randomised cross-over trial to improve effective contraception uptake through provision of the progestogen only pill (POP) plus sexual and reproductive health (SRH) clinic rapid-access to women presenting to community pharmacies for emergency contraception (EC).

Research Design And Methods: A multimethod process evaluation was conducted to assess intervention implementation, mechanisms of change and contextual factors. Data were gathered from screening logs (n=599), observations of pharmacist training, analysis of data from 4-month follow-up questionnaires (n=406), monitoring of contemporaneous events and qualitative interviews with 22 pharmacists, 5 SRH clinical staff and 36 study participants in three participating UK sites in Lothian, Tayside and London.

Early medical abortion by telemedicine in the United Kingdom: a costing analysis.

Objective: To determine the potential cost savings resulting from the introduction of routine early medical abortion (EMA) at home by telemedicine in the UK.

Design: A costing study.

Setting: The UK.

A review of the effectiveness of a progestogen-only pill containing norgestrel 75 µg/day.

Objectives: To review published data on the effectiveness of a progestogen-only pill containing norgestrel 75 µg/day which should be under consideration by the FDA in 2022 for sale over the counter in the US.

Study Design: A literature search in MEDLINE, EMBASE, and COCHRANE REVIEWS using specified search terms and adding related cross-references.

Results: We identified a total of thirteen relevant studies of women using norgestrel 75 µg/day.

Perspectives of obstetricians and midwives on the provision of immediate postpartum intrauterine devices: a qualitative service evaluation.

Background: Immediate postpartum intrauterine device (PPIUD) insertion is safe and effective but largely unavailable in Europe. Data on maternity staff views on the provision and implementation of PPIUD services are limited. The objective of this qualitative evaluation was to explore the views and experiences of obstetricians and midwives providing PPIUD within a UK maternity setting, in order to identify areas for improvement and inform service provision in other areas.

Assessing the Pregnancy Protective Impact of Scheduled Nonadherence to a Novel Progestin-Only Pill: Protocol for a Prospective, Multicenter, Randomized, Crossover Study.

Background: Progestin-only contraceptive pills (POP) are commonly reserved for women with medical comorbidities but in actuality, POPs can be safely used by anyone wanting to prevent pregnancy. This wide safety profile makes them an ideal candidate for being available over the counter without a prescription, but adherence issues may be more common with over-the-counter use. We need a better understanding of the ability of POPs to prevent pregnancy when adherence issues occur in the form of a missed or delayed pill.

Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT.

Introduction: Unless women start effective contraception after using emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies that are unable to provide ongoing contraception (apart from barrier methods which have high failure rates). This means that women need an appointment with a general practitioner or at a sexual and reproductive health clinic.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

Background: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception.

Abortion regulation in Europe in the era of COVID-19: a spectrum of policy responses.

Background: Unprecedented public health actions restricting movement and non-COVID related health services are likely to have affected abortion care during the pandemic in Europe. In the absence of a common approach to ensure access to this essential health service, we sought to describe the variability of abortion policies during the outbreak in Europe in order to identify strategies that improve availability and access to abortion in times of public health crises.

Methods: We collected information from 46 countries/regions: 31 for which country-experts completed a survey and 15 for which we conducted a desk review.

Women's experiences of accessing postpartum intrauterine contraception in a public maternity setting: a qualitative service evaluation.

Objectives: The aims of the study were to explore women's experiences of an immediate postpartum intrauterine contraception (PPIUC) service recently introduced in a UK maternity setting, to identify areas for improvement and inform service provision.

Methods: Qualitative research was carried out in hospital and community maternity services in Lothian, UK. In-depth interviews were conducted with 35 women who had received PPIUC at vaginal or caesarean delivery.

Emergency contraception from the pharmacy 20 years on: a mystery shopper study.

Background: Emergency contraception (EC) was approved in the UK as a pharmacy medicine for purchase without prescription in 2001. Twenty years later we conducted a study to characterise routine practice pharmacy provision of EC.

Study Design: Mystery shopper study of 30 pharmacies in Edinburgh, Dundee and London participating in a clinical trial of contraception after EC.

The effects on ovarian activity of delaying versus immediately restarting combined oral contraception after missing three pills and taking ulipristal acetate 30 mg.

Objective: Among combined oral contraception (COC) users, to determine the effect on ovarian activity and ovulation of waiting five days before restarting COC, versus restarting immediately, having taken ulipristal acetate 30 mg (UPA, the dose used for emergency contraception) after missing three consecutive COC pills.

Study Design: Women already using COC were enrolled for two cycles of COC use (21/7 regimen). In cycle 2, all women omitted COC pills for three consecutive days (days 5,6,7), and on day 8 took UPA 30 mg.

Changes in the prevalence and profile of users of contraception in Britain 2000-2010: evidence from two National Surveys of Sexual Attitudes and Lifestyles.

Aim: To describe prevalence and trends in contraceptive method use in Britain through a comparison of the second and third National Surveys of Sexual Attitudes and Lifestyles (Natsal-2 and Natsal-3).

Methods: Cross-sectional probability sample surveys. General population sample of women aged 16-44 years, resident in Britain, with ever-experience of vaginal sex and, for analysis by sociodemographic characteristics, vaginal sex in the last year.