Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Dean J
PROVIDER: S-EPMC6537409 | biostudies-literature | 2019 May
REPOSITORIES: biostudies-literature
Publications
Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.
Dean Joshua J Kramer Katherine J KJ Akbary Fauzia F Wade Shaunte S Hüttemann Maik M Berman Jay M JM Recanati Maurice-Andre MA
BMC women's health 20190528 1
<h4>Background</h4>To determine whether oral norethindrone acetate is superior to combined oral contraceptives (OCP) in delaying menstruation and preventing breakthrough bleeding when started late in the cycle.<h4>Methods</h4>This article comprises of a case control study followed by a pilot randomized controlled study. In the first study, four women who presented late in their cycle and desired avoiding vaginal bleeding within 10 days before a wedding were started on norethindrone 5 mg three ti ...[more]
Similar Datasets
Project description:ObjectiveTo synthesise evidence around over-the-counter (OTC) emergency contraceptive pills (ECPs) to expand the evidence base on self-care interventions.DesignSystematic review (PROSPERO# CRD42021231625).Eligibility criteriaWe included publications comparing OTC or pharmacy-access ECP with prescription-only ECPs and measuring ECP uptake, correct use, unintended pregnancy, abortion, sexual practices/behaviour, self-efficacy and side-effects/harms. We also reviewed studies assessing values/preferences and costs of OTC ECPs.Data sourcesWe searched PubMed, CINAL, LILACS, EMBASE, clinicaltrials.gov, WHO International Clinical Trials Registry Platform, Pan African Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, Cochrane Fertility Regulation and International Consortium for Emergency Contraception through 2 December 2020.Risk of biasFor trials, we used Cochrane Collaboration's tool for assessing risk of bias; for other studies, we used the Evidence Project risk of bias tool.Data extraction and synthesisWe summarised data in duplicate using Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence Profile tables, reporting findings by study design and outcome. We qualitatively synthesised values/preferences and cost data.ResultsWe included 19 studies evaluating effectiveness of OTC ECP, 56 on values/preferences and 3 on costs. All studies except one were from high-income and middle-income settings. Broadly, there were no differences in overall ECP use, pregnancy or sexual behaviour, but an increase in timely ECP use, when comparing OTC or pharmacy ECP to prescription-only ECP groups. Studies showed similar/lower abortion rates in areas with pharmacy availability of ECPs. Users and providers generally supported OTC ECPs; decisions for use were influenced by privacy/confidentiality, convenience, and cost. Three modelling studies found pharmacy-access ECPs would lower health sector costs.ConclusionOTC ECPs are feasible and acceptable. They may increase access to and timely use of effective contraception. Existing evidence suggests OTC ECPs do not substantively change reproductive health outcomes. Future studies should examine OTC ECP's impacts on user costs, among key subgroups and in low-resource settings.
| S-EPMC8921871 | biostudies-literature
Project description:BackgroundThe use of oral contraceptive pills (OCPs) as a birth control method is very common worldwide. OCPs have many other labeled non-contraceptive indications, and as a result there is an associated risk of improper use, as with any other medications. This study was designed to assess the unforeseen improper uses of OCPs observed by community pharmacists in Jordan.MethodA cross-sectional study design was conducted using a self-administered survey. A convenience sample (n = 380) of Jordanian community pharmacists, were recruited through social media resources. The survey included multiple-choice and open-ended questions. Descriptive statistics and correlation analyses were completed using SPSS.ResultsMore than half of the recruited pharmacists (55.3%) were female, and the mean age of the participants was 32.58 ± 9.94. The majority of the pharmacists (85%) had good knowledge about the non-contraceptive indications of OCPs. About 53% of them confirmed their exposure to cases of the improper use of OCPs. About 67.5% of the pharmacists who confirmed exposure to such cases, reported the topical use of OCPs for the enhancement of hair growth. Around 15% of those pharmacists stated that OCPs were used to give negative results for addictive drug screening tests. In the event that the pharmacists suspected improper use, more than 90% suggested they would refrain from dispensing the pills.ConclusionThis study has spotlighted many unforeseen uses of OCPs in Jordan and highlighted the need for restricted national regulations on the monitoring of OCP prescription/selling patterns in Jordan by policymakers. Moreover, there is a need for the establishment of national educational programs for the Jordanian community regarding the safe proper use of OCPs.
| S-EPMC7751968 | biostudies-literature
Project description:BackgroundOral contraceptive pills (OCPs) are one of the most reliable methods of contraception. However, lack of knowledge about oral contraceptive use and inconsistent pill-taking might result in decreased efficacy. The study reported here aimed to explore women's knowledge about oral contraceptive use and assess the factors associated with knowledge about OCPs among users.MethodsThis cross-sectional survey was conducted at King Abdulaziz University Hospital, Jeddah, Saudi Arabia between April and June 2014. We included married, non-pregnant women >18 years old who had used a combined 21-day OCP for at least 3 months prior to recruitment. A questionnaire was used to collect the participants' demographic information. It also assessed their knowledge about OCPs. Data were entered into and analyzed using SPSS software.ResultsA total of 357 women were recruited. Of these, 57.7% reported they knew what to do after missing one or two pills, but only 18.3% knew exactly what to do after missing more than two pills consecutively. Postgraduate women had a significantly higher knowledge score than illiterate women (P=0.002) and those who had completed at least primary education (P=0.001). Conversely, there was no difference in knowledge scores between Saudi and expatriate women (P=0.2). Monthly incomes (P=0.2) and mode of OCP selection (P=0.2) were also not significantly associated with knowledge scores.ConclusionWomen had poor knowledge about OCP use. Appropriate measures should be taken to educate women about proper oral contraceptive use.
| S-EPMC4362980 | biostudies-literature
Project description:ObjectiveThis study investigated the attitude of Korean physicians toward women's access to emergency contraceptive pills (ECPs) and the reclassification of ECP to a behind-the-counter (BTC) drug.MethodsThis study involved 946 physicians who had prescribed ECP in South Korea. The written questionnaires were completed by obstetricians and gynecologists, family physicians, internal medicine doctors, and pediatricians.ResultsRegarding the barriers limiting women's access to ECP, 24.8% of physicians responded that women lacked information about ECP and 22.5% felt that women were likely to be emotionally burdened by visits to clinics or hospitals to obtain ECP prescriptions. Ninety-two percent of physicians responded that ECP should remain a prescription drug while 6.1% stated preferences for a switch to a BTC drug. Physicians who opposed the switch were concerned about the potential abuse of ECP. In order to prevent ECP abuse, the most important factor to be considered was education on contraception.ConclusionA majority of Korean physicians opposed the reclassification of ECP to a BTC drug owing to their belief in increasing the role of educational initiatives about contraception and contraceptive practices before improving the access to ECP. This study is also of the opinion that contraceptive education for youth and adults in Korea should be more realistic and active, with an emphasis on regular contraception use before reclassification. Furthermore, we believe that efforts are needed to ensure accuracy of information on contraception to facilitate women's access to ECP.
| S-EPMC6520542 | biostudies-literature
Project description:ImportanceAs prescription drug costs rise, it is important to understand attitudes among primary care physicians and nurse practitioners (NPs) towards generic drugs.ObjectiveWe aimed to examine the generic skepticism index (GSI) among primary care clinicians, and their willingness to discuss and prescribe generic antidepressants (ADs) and generic oral contraceptives (OCPs).DesignWe used a factorial vignette design survey to test 4 factors: message source, message, brand preference, and drug class. Participants were randomized to different combinations of factors.SettingThis was a cross-sectional study.ParticipantsPhysicians registered with the American College of Physicians (ACP) and NPs registered with the American Association of Nurse Practitioners (AANP) participated in the study.Main measuresThe primary outcomes were generic skepticism as measured using the generic skepticism index (GSI), and clinician willingness to discuss and prescribe generics.ResultsSurveys were completed by 56% of physicians (n = 369/661) and 60% of NPs (n = 493/819). Compared with physicians, NPs were younger (p < 0.001), predominantly female (p < 0.001), and differed in the race (p < 0.001). According to the GSI, 16% (n = 138/862) were identified as generic skeptics (18.5% of NPs and 12.7% of physicians, p = 0.023). Generic skeptics had lower odds of willingness to discuss switching (OR 0.22, 95% CI (0.14-0.35), p < 0.001) or prescribe (OR 0.18, 95% CI (0.11-0.28), p < 0.001) generic OCPs. Participants had lower odds of willingness to prescribe generic drugs to patients with brand preference compared with brand-neutral patients (OR 0.64, 95% CI 0.50-0.82, p < 0.001).Conclusions and relevanceGeneric skepticism was associated with lower willingness to discuss or prescribe generic drugs. Clinicians reported lower willingness to discuss switching or prescribe generics for OCPs than for ADs. Patient brand preference hindered generic prescribing. Message source and message type were not significantly associated with outcomes.
| S-EPMC7728859 | biostudies-literature
Project description:ObjectivesTo describe changes in use and receipt of emergency contraceptive (EC) pills among women in the United States during a period of key EC policy changes, from 2008 to 2015.Study designUsing data from the 2006 to 2010 and 2013 to 2017 National Surveys of Family Growth, we present changes in the percent of women who ever used EC between 2008 and 2015 by select sociodemographic and sexual and reproductive health characteristics, and we examine multivariable relationships of these characteristics with EC ever use in 2015. We also examine changes in repeat EC use, receipt of EC counseling, reasons for EC use and source of EC between the time periods.ResultsAmong sexually experienced women ages 15 to 44, EC ever use increased from 11% in 2008 to 23% in 2015 overall and among nearly all groups of women. In 2015, age 20 to 29, non-Hispanic other or Hispanic race, at least a high school education, working part-time, income at least 100% of the federal poverty level, ever having been married, and having received EC counseling in the prior year all represent characteristics associated with higher odds of having ever used EC. In 2015, a smaller share of women last obtained EC with a prescription or at a health facility than in 2008.ConclusionsIncreases in EC use occurred as access to EC was broadened through regulatory changes that moved some forms of EC from behind-the-counter to fully over-the-counter between 2008 and 2015.ImplicationsOver-the-counter provision of many forms of EC pills may have increased access and introduced more flexibility in how EC is obtained, but these changes may have come with tradeoffs, both in the form of cost barriers and decreased opportunities for clinicians to discuss EC with their patients. Despite improved access to contraception more broadly through the Affordable Care Act, EC remains a necessary component of the overall contraceptive method mix, and clinicians can play a key role in discussing EC as one option among many during contraceptive counseling sessions.
| S-EPMC8176291 | biostudies-literature
Project description:Gonadal hormones influence neuronal organization and plasticity. Yet the consequences of altering their concentrations by administering contraceptive agents, which are used by most reproductive-age women in the United States, are unclear. Cross-sectional studies have found both larger and smaller cortical regions alongside a variety of mood alterations in women who use oral contraceptive pills (OCPs) compared to naturally-cycling women. The goal of this study, therefore, was to determine whether there is an effect of OCPs on MRI measures of prefrontal cortical brain structure that may influence regulation of mood. We performed a double-blind, placebo-controlled, randomized crossover study comparing effects of OCPs (0.15 mg levonorgestrel + 0.30 μg ethinyl estradiol) vs placebo (N = 26) on MRI measures of prefrontal cortical thickness and on mood, as indicated by self-report on the Daily Record of Severity of Problems, which also includes one item related to somatic symptoms. MRI measures that reflect cortical thickness were smaller bilaterally in the pars triangularis and in the pars opercularis and frontal pole of the right hemisphere during the OCP arm vs. placebo. Only the effect in the right pars triangularis survived multiple comparisons correction. Right pars triangularis MRI measures of cortical thickness were not related to mood symptoms, but negatively correlated across conditions with severity of somatic symptoms on the DSRP. The somatic symptoms and MRI measures may be independently related to the actions of steroid hormones in OCPs, with OCPs simultaneously inducing both more effects on MRI measures of cortical thickness and somatic symptoms.
| S-EPMC7914152 | biostudies-literature
Project description:BackgroundThis study was conducted to compare breast epithelial-cell proliferation and estrogen and progesterone receptor levels in women taking one of two oral contraceptives (OCs) containing the same dose of estrogen but different doses of the progestin norethindrone (NET).Study designThirty-three women were randomly assigned 1:1 to one of two OCs with 35-mcg ethinylestradiol (EE2) but different doses of NET - 1 or 0.4 mg. At the end of the active pill phase of the third OC cycle, a breast biopsy was performed and the percentages of epithelial cells of the terminal duct lobular units were measured for Ki67 (MIB1), progesterone receptors A and B (PRA and PRB, respectively), and estrogen receptor ? (ER?).ResultsThe biopsies from 27 women had sufficient epithelium for analysis. The percentages of cells positive for PRA, PRB and ER? were approximately double with the lower progestin dose (PRA: p=.041; PRB: p=.030; ER?: p=.056). The Ki67 percentage was not reduced with the lower progestin dose (12.5% for 0.4-mg NET vs. 7.8% for 1.0-mg NET).ConclusionsThe increase in PRA-, PRB- and ER?-positive cells with the 60% lower progestin dose OC appears likely to account for its failure to decrease breast-cell proliferation. This breast-cell proliferation result is contrary to that predicted from the results of lowering the medroxyprogesterone acetate dose in menopausal hormone therapy.
| S-EPMC3355208 | biostudies-literature
Project description:Importance:The Veterans Affairs (VA) health care system is the largest integrated health care system in the United States. Like most US health plans, the VA currently stipulates a 3-month maximum dispensing limit for all medications, including oral contraceptive pills (OCPs). However, 12-month OCP dispensing has been shown to improve continuation of use, decrease coverage gaps, and reduce unintended pregnancy in other practice settings. Objective:To estimate the financial and reproductive health implications for the VA of implementing a 12-month OCP dispensing option, with the goal of informing policy change. Design, Setting, and Participants:A decision model from the VA payer perspective was developed to estimate incremental costs to the health care system of allowing the option to receive a 12-month supply of OCPs up front, compared with the standard 3-month maximum, during a 1-year time horizon. A model cohort of 24?309 reproductive-aged, heterosexually active, female VA enrollees who wish to avoid pregnancy for at least 1 year was assumed. Probabilities of continuation of OCP use, coverage gaps, pregnancy, and pregnancy outcomes were drawn from published data. Costs of OCP provision and pregnancy-related care and the number of women using OCPs were drawn from VA administrative data. One-way and probabilistic sensitivity analyses were performed to assess model robustness. Main Outcomes and Measures:Incremental per-woman and total costs to the VA of allowing for 12-month dispensing of OCPs compared with standard 3-month dispensing. Results:The 12-month OCP dispensing option, modeled from the VA health system perspective using a cohort of 240 309 women, resulted in anticipated VA annual cost savings of $87.12 per woman compared with the cost of 3-month dispensing, or an estimated total savings of $2?117?800 annually. Cost savings resulted from an absolute reduction of 24 unintended pregnancies per 1000 women per year with 12-month dispensing, or 583 unintended pregnancies averted annually. Expected cost savings with 12-month dispensing were sensitive to changes in the probability of OCP coverage gaps with 3-month dispensing, the probability of pregnancy during coverage gaps, and the proportion of pregnancies paid for by the VA. When simultaneously varying all variables across plausible ranges, the 12-month strategy was cost saving in 95.4% of model iterations. Conclusions and Relevance:Adoption of a 12-month OCP dispensing option is expected to produce substantial cost savings for the VA while better supporting reproductive autonomy and reducing unintended pregnancy among women veterans.
| S-EPMC6618816 | biostudies-literature
Project description:IntroductionUterine Fibroids (UFs) are the most predominant benign tumor in women who are coming of reproductive age, and causes intense economic load priced in billions of US dollars. Historically, surgery has been the main definitive treatment, albeit less attractive nowadays, especially for women with future fertility plans. Therefore, studies to explore the pharmacological treatment options are increasing especially as those that are currently available are limited for short-term use only.Areas coveredThis drug evaluation features the clinical results from previous and ongoing studies of relugolix, in combination with the add back therapy of estradiol (E2) and norethindrone acetate (NETA), as a novel, orally administered, nonpeptide antagonist of gonadotropin-releasing hormone (GnRH) for the management of heavy menstrual bleeding (HMB) in premenopausal women with UFs.Expert opinionThe combination of relugolix/E2/NETA is an encouraging, well-tolerated and noninvasive pharmacological option for UFs patients. Relugolix induced a concentration-dependent decrease in HMB. However, it should be used with hormonal add-back therapy (E2+ NETA) to avoid induced hypoestrogenic side effects, importantly bone mineral density loss. Moreover, symptoms will likely resume shortly after the termination of the relugolix combination administration.
| S-EPMC8866208 | biostudies-literature