Progestin-only Pills Research Articles

Counseling Women About Sexual Health Effects of Contraceptives.

Background: Choosing a contraceptive method is a pivotal decision for patients, whereas health care professionals (HCPs) face challenges in providing suitable recommendations. Adverse sexual effects often lead to dissatisfaction and discontinuation of contraceptives, underscoring the importance of thorough counseling and shared decision making between HCPs and patients. Objective: This article aims to investigate the relationship between contraceptive methods and female sexual function through a comprehensive review of available literature, emphasizing the importance of considering sexual health in contraceptive prescription and management. Methods: A systematic analysis of existing literature, incorporating studies utilizing validated sexual health questionnaires, was conducted to elucidate the intricate interplay between contraceptives and female sexual function. Results: The review encompasses various contraceptive methods, including combined hormonal contraceptives, progestin-only pills, depot medroxyprogesterone acetate, subdermal contraceptive implants, hormonal intrauterine devices, permanent sterilization, and barrier methods. Insights gleaned from the analysis shed light on the impact of these methods on female sexual health. Conclusion: Comprehensive understanding of the effects of contraceptives on female sexual function is crucial for both HCPs and patients. By integrating sexual health considerations into contraceptive surveillance, compliance can be improved, contraceptive efficacy optimized, and the risk of unwanted pregnancies minimized. This review underscores the significance of tailored counseling and shared decision making in contraceptive management, particularly for cisgender women.

Reported side effects from hormonal contraceptives among those seeking abortion care versus contraceptive services.

We aim to describe and compare the prevalence of subjective side effects associated with hormonal contraceptive use among reproductive healthcare users seeking either abortion care or contraceptive services. This substudy derives from a previously reported cross-sectional survey involving 1006 users of public reproductive healthcare services in the Helsinki metropolitan area in Finland. We included all 813 respondents with a history of hormonal contraceptive use (mean age 27 years, IQR 24-33 for abortion care; 24 years, IQR 19-30 for contraceptive services). The study followed STROBE guidelines. Altogether 400 respondents sought abortion care, while 413 sought contraceptive services (counselling, prescription renewal, symptoms and/or dissatisfaction with their contraceptive method). Combined oral contraceptives and progestin-only pills were the most used methods in both groups. Respondents seeking abortion care reported contraception-associated weight changes, sex-related problems, mood changes, and acne more frequently than those seeking contraceptive services (p-value<0.05 for all). Some 52% of respondents seeking abortion care reported mood changes compared with 29% of those seeking contraceptive services, with a crude OR of 2.7 (95% CI 2.00 to 3.57). After adjustment, the OR for reporting mood changes among respondents seeking abortion care was 1.5 (95% CI 1.05 to 2.23). Mood changes associated with hormonal contraceptive use were the most frequently reported side effect among all respondents. These findings suggest a need for individualised counselling on mood-related side effects as mood changes may contribute to higher discontinuation rates.

Lower reporting of venous thromboembolisms events with natural estrogen-based combined oral contraceptives compared to ethinylestradiol-containing pills: A disproportionality analysis of the Eudravigilance database

ObjectivesPharmacovigilance data analysis can accelerate the identification of drug-related safety signals or reassure on the safety profile. This study evaluates the venous thromboembolism (VTE) risk of newer combined oral contraceptive (COC) formulations with natural estrogens, such as estradiol (E2) and estetrol (E4), using data from the EudraVigilance database. Study designWe conducted a disproportionality reporting rate analysis of VTE events associated with various COC formulations by extracting individual case reports from EudraVigilance database up to July 28, 2024. The study compared the proportionality reporting rate between natural estrogen-based COCs (E2 and E4) and conventional synthetic estrogen-based COCs (ethinylestradiol [EE]), with a comparison to EE-levonorgestrel. ResultsThe analysis revealed that COCs containing natural estrogens exhibited significantly lower proportionality reporting rates for thrombotic events compared to EE-based COCs. Specifically, E4-drospirenone (E4-DRSP) showed the lowest proportionality reporting rate (0.12), similar to progestin-only pills. EE-DRSP had the highest proportionality reporting rate (2.25), suggesting an increased thrombotic risk. ConclusionsThe study supports the safer thrombotic profile of natural estrogen-based COCs, particularly E2 and E4 formulations, over synthetic estrogen-based COCs containing EE. These findings support the hypothesis that E2- and E4-based pills are safer than EE-based pills, aligning with a shift toward safer contraceptive options in clinical practice. ImplicationsNatural estrogens such as E2 and E4 may emerge as safer alternatives to synthetic estrogens like EE, particularly when combined with progestins like DRSP. This multilevel evidence underscores the importance of evidence-based prescribing practices to enhance patient safety and minimize thrombotic risks associated with COC use.

A REVIEW STUDY ON ROLE OF CONTRACEPTIVES AND THEIR VARIOUS TYPES.

Contraception is the process used to stop unwanted pregnancy and control birth rate. Contraceptives reduces the chances of pregnancy after sexual intercourse. Contraceptives prevent pregnancies by interfering with the procedure of fertilization. Contraceptives reduces the chances of abortion by preventing unintended pregnancies on their partners, in which 842 million (44%) are modern using modern methods of Contraceptives are accessible in huge varieties and types . Numerous contraceptives are available, 790 million (42%) are traditional method users according the statistical data of 2019. The most common contraceptive techniques that are use of contraceptives are increasing day by day, 922 million of women of reproductive age used worldwide are female sterilization and male condoms, female sterilization are used in 219 million users (24%), male condoms are used in 189 million users (21%) according the data of 2019. The use of traditional methods and IUDs has reduced worldwide since 1994. According to WHO, The only form of birth control is a condom,that can prevent both unintended pregnancies and sexually transmitted diseases. The need of family planning is increased globally up to 77% from 2015 to 2020.. Over the past 20 years, the number of women using family planning methods has grown, rising from 900 million in 2020 to 2000 million. Use of modern contraceptive methods is also increased from 663 million to 851 million with the prevalence rate of 47.7% to 49.0%. Numerous contraceptive methods exist, including hormonal methods like CHC vaginal ring, CHC transdermal patch, and combination hormonal contraceptives. Progestin-only techniques include hormonal male contraceptives, progestin-only pills, DMPA injections, implants, and progestin-only IUDs. The other approach is non-hormonal and consists of vaginal pH modulators, barrier techniques like condoms, and copper IUDs. Traditional methods, such as the LAM method, the fertile cycle method, and the withdrawal approach, comprise the third type of contraception. Herbal contraceptives, which use a variety of herbs and plant preparations, are the fourth technique of birth control.

Understanding and Offering Counseling to Your Patients about the First Over the Counter Progestin-Only Oral Contraceptive (OPill®).

Understanding and Offering Counseling to Your Patients about the First Over the Counter Progestin-Only Oral Contraceptive (OPill®).

Treatments of unscheduled vaginal bleeding due to progestin-only contraception.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the effectiveness, safety, and side effects associated with the usage of different treatments for unscheduled vaginal bleeding in premenopausal women using progestin-only pills.

Challenges to Contraceptive Counseling With Isotretinoin Treatment and Future Directions for Dermatologists

Accutane, also known as isotretinoin, is an oral systemic retinoid utilized in the treatment of severe, treatment-resistant acne. Isotretinoin is a pregnancy category X drug, meaning that studies have documented congenital defects in pregnant patients on isotretinoin. Known abnormalities include ear abnormalities, facial dysmorphia, cleft palate, CNS abnormalities, thymus gland abnormalities, and parathyroid hormone deficiencies. With teratogenicity well-documented with isotretinoin use, the iPLEDGE system was created to educate prescribers, pharmacists, and patients about the risks of isotretinoin use. Utilizing iPLEDGE, individuals of child bearing potential (ICBP) are required to document two negative pregnancy tests before the initiation of isotretinoin therapy with two documented forms of birth control. We conducted a literature review utilizing the terms: accutane, isotretinoin, contraception, and birth control. We found that amongst multiple articles, the most popular primary contraceptive methods in iPLEDGE were abstinence (47% of users) and combined oral contraceptives (31% of users). Individuals have attributed their lack of contraceptive use to fear of birth control health impacts and belief in the equivalent effectiveness of non-accepted methods (e.g. withdrawal and natural family planning. Despite the establishment of iPLEDGE to systematically reinforce counseling requirements, the incidence of isotretinoin-exposed pregnancies continues to persist with approximately 100-200 pregnancies annually. Given these findings, it is clear that counseling is tantamount to dispelling misconceptions regarding contraception and optimizing rates of patient compliance. Despite this importance, counseling remains a large issue for dermatologists. Only half of board-certified dermatology residents surveyed in 2023 felt comfortable providing counseling on adverse effects of combined oral contraceptives (COCs), and only 38.8% felt comfortable providing counseling directions for COCs. Solutions for this include quickly accessing a referral to primary care or OB/GYN and potentially new avenues that are more easily accessible such as the progestin-only oral contraceptive pill that was recently approved for over the counter use by the United States Food and Drug Administration.

No association between oral contraceptive exposure and subsequent MS: A population-based nested case–control study in primary care

Background: Conflicting data exist around oral contraceptive exposure and subsequent multiple sclerosis (MS). Objective: To use routinely collected primary healthcare data to explore the potential association between oral contraceptive exposure and subsequent MS in females at population level. Methods: We performed a nested case–control study using electronic primary care data, with complete electronic ascertainment from 1990. Logistic regression was used to evaluate associations between contraceptive exposure and MS, without and with adjusting for age, ethnicity and deprivation. Results: A total of 4455 females were included: 891 cases and 3564 controls. No association was seen between oral contraceptive exposure and subsequent MS, or between any contraceptive, combined oral contraceptive pill (COCP) or progesterone-only pill (POP) use 0–2, 2–5 or >5 years prior to MS. Conclusions: In the largest population-based study to date, we find no evidence of an association between oral contraceptive exposure and subsequent MS diagnosis.

Approval of the First Nonprescription Oral Contraceptive Pill

In July 2023, the U.S. Food and Drug Administration approved Opill (norgestrel 0.075 mg), a progestin-only tablet to prevent pregnancy to be used without a prescription. Although progestin-only birth control pills were approved in 1973, it has taken 50 years for the first oral contraceptive pills to be sold over the counter. In this column, I review the evidence on the barriers to access oral contraceptive pills, the efficacy, preferences and support of a nonprescription progestin-only pill, the cost, and policy implications for health insurance coverage. I conclude with recommendations from professional organizations on over-the-counter access to hormonal contraception.

How have changes in accessibility and public funding influenced contraceptive use among Norwegian adolescents? A cohort study.

The Norwegian Government introduced in 2002 a reimbursement scheme for hormonal contraceptives to adolescents at the same time as public health nurses and midwives received authorization to prescribe hormonal contraceptives. This study examines the impact of increased accessibility and public funding on hormonal contraceptive use among adolescents. The Norwegian Prescription Database, Statistics Norway, and Norwegian Institute of Public Health served as data sources for this cohort study. The study population comprised 174 653 Norwegian women born 1989-1990, 1994-1995, and 1999-2000. We examined use of hormonal contraceptives through dispensed prescriptions from age 12 through age 19 with duration of first continuous use as primary outcome. The statistical analyses were done in SPSS using chi-squared test, survival analysis, and Joinpoint regression analysis with p-values < 0.05. By age 19, ~75% of the cohorts had used at least one hormonal method. The main providers of the first prescription were general practitioners and public health nurses. Starters of progestogen-only pills (POPs) have increased across the cohorts, while starters of combined oral contraceptives (COCs) have decreased. The use of long-acting reversible contraceptives (LARCs) has increased since its inclusion in the reimbursement scheme (2015). Most switchers shifted from COCs or POPs as a start method to implants after LARCs became part of the reimbursement scheme. There has been a significant increase across the cohorts in the number of women who continuously used hormonal contraceptives from start to the end of the calendar year they became 19 years with the same method and after switching methods. We could not correlate changes in decreasing trends for teenage births or induced abortions (Joinpoint analysis) to time for implementation or changes in the reimbursement of hormonal contraceptives from 2002. Primarily public health nurses and to a lesser extent midwives became soon after they received authorization to prescribe COCs important providers. The expansion of the reimbursement scheme to cover POPs, patches, vaginal ring, and depot medroxyprogesterone acetate in 2006 had minor impact on increasing the proportion of long-term first-time users. However, the inclusion of LARCs in 2015 significantly increased the proportion of long-term first-time hormonal contraceptive users.

A randomized single-blind non-inferiority trial of delayed start with drospirenone-only and ethinyl estradiol-gestodene pills for ovulation inhibition

We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl estradiol (EE) and 0.075 mg of gestodene (GS) in ovulation inhibition and inducing unfavorable cervical mucus changes using a delayed-starting approach. This randomized controlled trial involved 36 participants aged 18–45 years. The major outcomes included ovulation inhibition assessed using the Hoogland and Skouby score, and cervical mucus permeability, assessed using the modified World Health Organization score. The results demonstrated ovulation inhibition rates of 77.8% for the EE/GS group and 88.9% for the DRSP group. The risk ratio and absolute risk reduction were 0.50 (95% confidence interval [CI]: 0.10, 2.40) and − 0.11 (95% CI: − 0.35, 0.13), respectively, satisfying the 20% non-inferiority margin threshold. The median time to achieve unfavorable cervical mucus changes was comparable between the DRSP (3 days, interquartile range [IQR]: 6 days) and EE/GS (3.5 days, IQR: 4 days) groups. However, the DRSP group had a higher incidence of unscheduled vaginal bleeding (55.56% vs. 11.11%; p = 0.005). DRSP-only pills, initiated on days 7–9 of the menstrual cycle, were non-inferior to EE/GS pills in ovulation inhibition. However, they exhibited delayed unfavorable cervical mucus changes compared to the standard two-day backup recommendation.Clinical trial registration: Thai Clinical Trials Registry (TCTR20220819001) https://www.thaiclinicaltrials.org/show/TCTR20220819001.

Development of deep pelvic endometriosis following acute haemoperitoneum: a prospective ultrasound study.

Is acute haemoperitoneum that is managed conservatively a precursor of deep endometriosis? Our study provides evidence to suggest that acute haemoperitoneum may lead to the development of deep endometriosis in a significant proportion of cases. A recent pilot study was the first to suggest that acute haemoperitoneum could be a precursor of deep endometriosis. However, the sample size was small, and the follow-up was not standardized owing to unknown rates of clot absorption and development of endometriosis. This was a prospective observational cohort study conducted at a single centre over a 31-month period. A required sample size of 30 was calculated using results from a previous study, with a minimum of 15 women each in the groups with and without significant haemoperitoneum (study and control groups, respectively). A total of 59 women were recruited to the study and eight were lost to follow-up. The final sample comprised 51 women, 15 in the study group and 36 in the control group. All non-pregnant, premenopausal women aged 18-50 years who consecutively presented to our dedicated gynaecological diagnostic unit with severe acute lower abdominal pain were eligible for this study. We only included women who were clinically stable and were suitable for conservative management. Those with prior history or evidence of endometriosis on their initial ultrasound scan, previous hysterectomy, or bilateral oophorectomy were excluded. Participants had standardized follow-up visits for 6 months, with pelvic ultrasound scans and the British Society of Gynaecological Endoscopy pelvic pain questionnaires completed at each visit. The primary outcome was the sonographically confirmed presence of newly formed endometriosis. Secondary outcomes were the presence and change of pelvic pain symptoms and health-related quality of life (HR-QOL). After completion of follow-up, 7/15 (47%; 95% CI 21.3-71.4%) women presenting with acute haemoperitoneum (study group) developed sonographic evidence of deep endometriosis, compared to 0/36 (0%; 97.5% CI 0.0-9.7%) women in the control group. A ruptured functional haemorrhagic cyst was the most common cause of haemoperitoneum, occurring in 13/15 cases (87%). The time from the initial event to sonographic evidence of endometriosis varied from 2 to 6 months. The EuroQol visual analogue scores were not significantly different at baseline between the groups that developed and did not develop endometriosis [28 (interquartile range (IQR) 15-40, n = 6) vs 56 (IQR 35-75, n = 44), P = 0.09], while the EuroQol-5D values were lower in the endometriosis group [-0.01 (IQR -0.07 to 0.19, n = 6) vs 0.62 (IQR 0.24-0.73, n = 44), P = 0.002]. At 6 months, the EuroQol-5D scores were improved in both groups, but remained significantly lower in the endometriosis group compared to the no endometriosis group [0.69 (IQR 0.66-0.80, n = 6) vs 0.85 (IQR 0.76-1.00, n = 44), P = 0.03]. There was no clinically relevant difference in the pelvic pain scores at either time point. It remains uncertain whether minimal, superficial endometriosis existed at commencement of the study and had a role in the development of deep endometriosis. Although the ultrasound findings were in keeping with deep endometriosis, this was not confirmed histologically. The pelvic pain and HR-QOL findings could have been influenced by the baseline scores being taken when the patient was admitted with acute pain. Also, the sample size was too small to draw reliable conclusions regarding the impact of newly developed endometriosis on QoL. Our study provides further evidence showing that significant haemoperitoneum may be a precursor of deep endometriosis. Haemodynamically stable women presenting with acute pelvic pain and significant haemoperitoneum should be counselled about the risk of developing deep endometriosis. Interventional studies should be carried out in the future to see whether laparoscopy and pelvic washout could prevent development of deep endometriosis. Preventative strategies, including treatment to suppress ovulation and formation of functional cysts, should be further investigated. This includes the combined and progesterone-only contraceptive pills. Larger future studies are also required to assess women over a longer period of time, with adjustment for confounding factors, to evaluate a possible effect on HR-QOL and pain symptoms. Funding was obtained from The Gynaecology Ultrasound Centre, London, UK. TT received personal fees from GE, Samsung, Medtronic, and Merck for lectures on ultrasound. TT also received a postdoctoral grant from the South-Eastern Norwegian Health Authority (grant number 2020083). researchregistry6472.

Couple-Years of Protection Indicator: New Global Guidance for Updating Existing Methods and Adding New Methods.

Couple-years of protection (CYP) is an indicator that allows for monitoring and evaluating of family planning (FP) program performance through simple calculations. The CYP for each contraceptive method is calculated by multiplying the number of contraceptive commodity units distributed to clients over a 1-year period by a conversion factor that quantifies the duration of contraceptive protection provided per unit distributed. CYP calculations across methods were previously updated in 2000 and 2011, resulting in changes in methodology, factor inclusion, and specific methods. Since the 2011 update, changes and additions to the modern contraceptive method mix required new CYP conversion factors for 4 methods of contraception: Levoplant implant, progestin-only pills (POPs), Caya diaphragm, and the hormonal intrauterine device. We conducted literature reviews of both published and gray literature and consulted with experts to identify updated data on continuation rates, duration of efficacy, and method effectiveness for the 4 methods. New CYP conversion factors were calculated for the 4 methods either by using the same calculation used previously for the method considering new data or, for new methods, using calculations for similar methods. New CYP conversion factors were assigned to the 4 methods of contraception covered in this update: Levoplant, 2.5 CYP per implant inserted; POPs, 0.0833 CYP per pack (i.e., 12 cycles per CYP); Caya diaphragm, 1 CYP per device, and hormonal intrauterine device, 4.8 CYP per device inserted. CYP is an important indicator for FP programs. As new methods of contraception are developed and new evidence is generated for current methods, the indicator may need to be updated. A standard process for updating and documenting future CYP updates is recommended.

Drospirenone (Slynd)

&#x0D; CADTH recommends that Slynd should be reimbursed by public drug plans for conception control in adolescent and adult women if certain conditions are met.&#x0D; Slynd should be covered for conception control in adolescent and adult women provided that Slynd is listed in a similar way to other oral contraceptive pills currently reimbursed by public drug plans for the prevention of pregnancy.&#x0D; Slynd should only be reimbursed if the cost does not exceed that of other progestin-only pills (POPs) for contraception.&#x0D;

Use of hormones and risk of venous thromboembolism.

•The risk of venous thromboembolism (VTE) is not increased in women using long-acting reversible contraceptive methods (LARCs) with progestogens. •Oral contraceptives with levonorgestrel or norgestimate confer half the risk of VTE compared to oral contraceptives containing desogestrel, gestodene or drospirenone. •Progestogen-only pills do not confer an increased risk of VTE. •Women using transdermal contraceptive patches and combined oral contraceptives (COCs) are at an approximately eight times greater risk of VTE than non-users of hormonal contraceptives (HCs), corresponding to 9.7 events per 10,000 women/years. •Vaginal rings increase the risk of VTE by 6.5 times compared to not using HC, corresponding to 7.8 events per 10,000 women/years. •Several studies have demonstrated an increased risk of VTE in transgender individuals receiving hormone therapy (HT). •Hormone therapy during menopause increases the risk of VTE by approximately two times, and this risk is increased by obesity, thrombophilia, age over 60 years, surgery and immobilization. •The route of estrogen administration, the dosage and type of progestogen associated with estrogen may affect the risk of VTE in the climacteric. •Combined estrogen-progesterone therapy increases the risk of VTE compared to estrogen monotherapy. •Postmenopausal HT increases the risk of thrombosis at atypical sites.

The Efficacy, Safety, and Tolerability of an Estrogen-Free Oral Contraceptive Drospirenone 4 mg (24/4-Day Regimen) in Obese Users

(Abstracted from Contraception 2023;128:1–7 There is a lack of data regarding the safety and efficacy of oral contraceptives in people with a body mass index (BMI) over 35. Drospirenone 4 mg is a new progestogen-only contraceptive pill that is taken in a 24 + 4 pattern, with 24 hormonal and 4 placebo pills.

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

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. 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. 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.

Progestogen only contraception in women with congenital heart disease

Background There is little information of progestogen-only contraceptives in patients with congenital heart disease (CHD) on the long-term. Objective To evaluate the use of contraception in patients with CHD. We studied both short-acting reversible contraceptives (SARCs), oral progestin-only pills (POPs) and long-acting reversible contraceptives (LARCs): intrauterine devices (IUD-IPs) and subdermal implants both impregnated with progestogens (SI-IPs). Study design Retrospective study of all women attending the preconception clinic. Contraceptive methods were classified in three TIERs of effectiveness before and after consultation. ESC classification regarding pregnancy risk, WHOMEC classification for combined oral contraceptive safety was collected. Results Six hundred and fifty-three patients. A significant proportion of them switched from TIER 3 to TIER 2 or 1 (p < .001) after consultation. One hundred and ninety-nine patients used POPs, 53 underwent IUD-IPs implantation and 36 SI-IPs, mean duration was 58 ± 8, 59 ± 8 and 53 ± 38 months, respectively. Conclusions Because of their safety and efficacy, IUD-IPs and SI-IPs should be considered as first-line contraception in patients with CHD.

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

ObjectivesIn 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 designTwo studies assessed self-selection: (1) an all-comers, actual-use study evaluating self-selection before purchasing and using norgestrel 0.075 mg and (2) the Targeted Breast Cancer Self-Selection Study evaluating theoretical self-selection among participants with a history of breast cancer. ResultsIn the actual-use study, based on the label, 1670/1772 participants (94%) were appropriate for use of norgestrel 0.075 mg; 102 (6%) were not appropriate. Of the 102, 66 (65%) correctly did not select and 36 (35%) responded it was okay for them to use norgestrel 0.075 mg. Of the 36 participants who incorrectly self-selected, one had a history of breast cancer and thus might have been adversely affected had they taken norgestrel 0.075 mg. In the Targeted Breast Cancer Self-Selection Study (N = 206), 97% of participants correctly stated norgestrel 0.075 mg was not appropriate for them. ConclusionsThe proposed over-the-counter label enables 98% of potential users to self-select norgestrel 0.075 mg appropriately. Only 2% of potential purchasers may have bought and started to use norgestrel 0.075 mg inappropriately. For two-thirds of these, the potential benefits of their use of the method outweighed any theoretical risks. Adverse clinical consequences of norgestrel 0.075 mg use are unlikely even in those rare cases when the drug facts label was not followed. ImplicationsThe balance of the risk of inappropriate selection to the benefit of taking an over-the-counter progestin-only pill appears to be very much in favor of an overall benefit in terms of unintended pregnancy prevention.

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

ObjectiveThe 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 designAn actual use study in a simulated OTC environment assessed adherence to directions to take norgestrel 0.075 mg every day at the same time in 883 participants for up to 24 weeks. ResultsEighty-five percent (747/883) of participants reported ≥85% adherence to taking norgestrel 0.075 mg every day and reported taking their dose within three hours of their scheduled dosing time on 96% of days.When accounting for use of a condom for 48 hours if a pill was missed, participants reported correctly following the label’s directed use for 97% of doses overall, with 95% of participants following label directions for ≥85% of doses.The main limitations were related to finding a balance between intensely collecting data to ensure accurate assessment of adherence and leaving users to behave as they would in a real OTC situation without healthcare practitioner intervention. We observed that some participants reported taking more doses than they could have based on the supply of medication given to them. To fully examine the situation, and the impact on the conclusions, additional post hoc sensitivity analyses were performed, and showed remarkably consistent results. ConclusionsConsumers were highly adherent to taking norgestrel 0.075 mg when using only the information provided by the proposed OTC label. ImplicationsAdherence to a daily oral contraceptive pill was high when obtained OTC. This suggests that effectiveness of an OTC pill is likely to be like that of a prescribed pill and easier access to this effective contraceptive should allow more opportunity to prevent pregnancy.