Expert opinion on the use of contraception in people with multiple sclerosis.

BACKGROUND: Current guidance on the selection of appropriate contraception for people with multiple sclerosis (PwMS) is lacking. OBJECTIVE: To address this gap, an expert-led consensus program developed recommendations to support clinicians in discussing family planning and contraception with women and men with multiple sclerosis (MS). METHODS: A multidisciplinary steering committee (SC) of 13 international clinical experts led the program, supported by an extended faculty of 32 experts representing 18 countries. A modified Delphi methodology was used for decision-making and consensus-building. The SC drafted 15 clinical questions focused on patient-centered care, selection of contraception, and timing of stopping/starting contraception and disease-modifying therapies (DMTs). Statements addressing each question were drafted based on evaluation of published evidence and the experts' clinical experience. Consensus was reached if ⩾75% of respondents agreed (scoring 7-9 on a 9-point scale) with each recommendation. RESULTS: Consensus was reached on 24 of 25 proposed recommendations, including how and when to discuss contraception, types and safety of contraceptives, and how to evaluate the most appropriate contraceptive options for specific patient groups, including those with significant disability or being treated with DMTs. CONCLUSION: These expert recommendations provide the first practical, relevant, and comprehensive guidance for clinicians on the selection of contraception in PwMS.

Endometriosis features and dienogest tolerability in women with depression: a case-control study.

OBJECTIVE: Primary aim of this study was to investigate endometriosis characteristics of patients with psychiatric conditions or depression. The secondary aim was to study tolerability of dienogest in this context. METHODS: This observational case-control study included endometriosis data from patients visiting our clinic from 2015-2021. We collected information from patient charts and in phone interviews based on a structured survey. Patients with surgical confirmed endometriosis were included. RESULTS: 344 patients fulfilled the inclusion criteria: n = 255 no psychiatric disorder, n = 119 any psychiatric disorder and n = 70 depression. Patients with depression (EM-D, p=.018; p=.035) or psychiatric condition (EM-P, p=.020; p=.048) suffered more often from dyspareunia and dyschezia. EM-P patients had more often primary dysmenorrhoea with higher pain scores (p=.045). rASRM stage or localisation of lesions did not differ. EM-D and EM-P patients discontinued dienogest treatment more often related to worsening of mood (p= .001, p=.002). CONCLUSION: EM-D or EM-P had a higher prevalence of pain symptoms. This could not be attributed to differences in rASRM stage or location of endometriosis lesions. Strong primary dysmenorrhoea might predispose to develop chronic pain-based psychological symptoms. Therefore, early diagnosis and treatment are relevant. Gynaecologist should be aware of the potential impact of dienogest on mood.

Women with endometriosis and psychiatric disorders especially have more dyschezia and dyspareunia, independent from rASRM stage, depth of infiltration and localisation of endometriosis lesions. Dienogest has an impact on mood especially in already prone patients.Trial registration: trial registration number: NCT04816357. https://clinicaltrials.gov/ct2/show/NCT04816357Date of registration: 22.03.2021, date of enrolment of the first subject: 25.03.2021.

Endometriosis Features in Women With and Without Migraine.

Background: This study examines endometriosis (EM) features in women with EM and migraines (MG) (EM-MG) and women with EM alone (EM-O). The comorbidity of MG and EM is well known. However, knowledge about differences in symptoms, clinical manifestations, and severity of EM between EM-MG and EM-O is scarce. Materials and Methods: We conducted a cross-sectional observational study of premenopausal patients with biopsy-confirmed EM treated in our department from 2015 to 2021. All patients underwent surgical treatment for EM. Information about infiltration depth and localization of EM was available. We interviewed patients using a structured questionnaire that includes questions about clinical characteristics, symptoms, and treatment history. We reported categorical variables as frequencies and continuous variables as means with standard deviations. We compared subgroups (EM-MG vs. EM-O) using an independent sample t-test, the Wilcoxon-Mann-Whitney test, chi-square test, and Fisher's exact test. The significance level was 0.05. Results: We included 344 participants: 250 with EM-O and 94 with EM-MG. EM-MG had less severe revised American Society of Reproductive Medicine scores (p = 0.023), more deliveries (p = 0.009), more and higher scores of dysmenorrhea at menarche (p = 0.044; p = 0.036), prolonged heavy menstrual bleeding (p = 0.009), more and prolonged pain during menstrual bleeding (p = 0.011, p = 0.039), and more dyschezia (p < 0.001) compared with EM-O. Conclusion: Migraineurs experienced more intense EM symptoms at lower EM stages. This discrepancy strongly indicates pain sensitizations and a lower pain threshold in patients with EM-MG. Knowledge about EM features allows early diagnosis and treatment of women with potential EM-MG, both highly disabling conditions. Clinical Trials.gov (NCT04816357).

Migraine and Happiness.

Objective: To investigate the association between happiness and migraine. Background: Contemporary operationalizations of happiness include the prevailing positive over negative affect and the satisfaction with life. Generally, extreme events and circumstances influence happiness only temporarily. However, how does periodic cycling between being relatively healthy and relatively disabled-as in migraineurs-affect happiness? Migraine is a primary headache disorder, in which headache attacks intermittently interfere with normal living and cause a significant personal, societal, and potentially irreversible disease burden. Methods: In this cross-sectional observational study, migraineurs completed the satisfaction with life scale (SWLS), the Patient Health Questionnaire, and the Generalized Anxiety Disorder scale and reported their headache frequency as well as recent changes in that frequency. Furthermore, participants answered a free text question on how to remain happy despite migraine attacks. We built a regression model with the SWLS score as the dependent variable. Results: Seventy participants completed the questionnaire. The regression model revealed that happiness increases with headache days, and subsequent analysis showed a U-shaped relationship between headache frequency and happiness. The participants' advice on remaining happy focused on upvaluing the pain-free time or relieving the attacks themselves. The latter was increasingly common with longer disease durations. Conclusions: Both high and low headache frequencies facilitate adaptation to the disorder, while intermediate frequencies resulted in lower life satisfaction. The nonlinear relationship between happiness and headache days may be due to "hedonic habituation" and implies that headache calendars do not necessarily correctly reflect patients' difficulty to feel well despite the disorder. Many patients advised other migraineurs to increase happiness by enjoying pain-free time. However, with increasing disease duration, patients' recommendations focused on coping with attacks.

Clinical features of migraine with onset prior to or during start of combined hormonal contraception: a prospective cohort study.

Many studies have described the features of menstrually related migraines but there is a lack of knowledge regarding the features of migraine in combined hormonal contraceptive users (CHC). Hormone-withdrawal migraines in the pill-free period could differ from those in the natural cycle. Gynaecologic comorbidities, like dysmenorrhea and endometriosis, but also depression or a family history might modify the course of migraine. A better understanding of migraine features linked to special hormonal situations could improve treatment. For this prospective cohort study, we conducted telephone interviews with women using a CHC and reporting withdrawal migraine to collect information on migraine frequency, intensity, triggers, symptoms, pain medication, gynaecologic history and comorbidities (n = 48). A subset of women agreed to also document their migraines in prospective diaries. The mean number of migraine days per cycle was 4.2 (± 2.7). Around 50% of these migraines occurred during the hormone-free interval. Migraine frequency was significantly higher in women who suffered from migraine before CHC start (5.0 ± 3.1) (n = 22) in comparison to those with migraine onset after CHC start (3.5 ± 2.1) (n = 26). Menstrually related attacks were described as more painful (57.5%), especially in women with migraine onset before CHC use (72%) (p < 0.02). Comorbidities were rare, except dysmenorrhea. The majority of migraine attacks in CHC users occur during the hormone-free interval. Similar as in the natural cycle, hormone-withdrawal migraines in CHC users are very intense and the response to acute medication is less good, especially in those women, who developed migraine before CHC use.

Dealing with Headache: Sex Differences in the Burden of Migraine- and Tension-Type Headache.

OBJECTIVE: The aim of this study was to investigate sex differences in the burden of migraine and tension-type headache (TTH). BACKGROUND: Migraine and TTH are more common in women than in men, with differences in comorbidities, treatment responses, disease-modifying factors, and ictal and interictal burden of disease. Information about sex-related influences on ictal and interictal burden is limited, and an increased understanding is mandatory to provide tailored individual treatment for female and male patients. METHODS: Participants answered an online survey based on the EUROLIGHT questionnaire. Inclusion criteria were the consent to participate, complete responses to the diagnostic questions, and information about their sex. Sex differences were investigated using the Mann-Whitney U test or Chi-square test. For detecting factors that influence the burden of disease, we built binary regression models. RESULTS: We included 472 (74.6% female) migraineurs and 161 (59.6% female) participants with TTH. Women with migraine reported significantly more problems in their love lives, more self-concealment, less feelings of being understood by family and friends, more interictal anxiety, a higher pain severity, and more depression and anxiety symptoms than men. For TTH, we did not find significant sex-related differences. A higher headache frequency was the factor that increased the burden of disease in female but not in male migraneurs. CONCLUSION: The burden of disease was higher in women than men with migraine in many aspects, but not with TTH. Therefore, according to our results, there is a need for sex-specific precision medicine for migraine but not TTH. Controlling the headache frequency with a proper acute or prophylactic treatment and treating comorbid depression and anxiety symptoms is crucial to ease migraine's burden, especially in women.

Migraine start, course and features over the cycle of combined hormonal contraceptive users with menstrual migraine - temporal relation to bleeding and hormone withdrawal: a prospective diary-based study.

BACKGROUND: Many studies have described the features of menstrually-related migraines (MRM) in the natural cycle and the efficacy of prevention. MRM in combined hormonal contraceptive (CHC) users has scarcely been researched. Estrogen and progestin withdrawal in CHC users are both more abrupt and from higher hormone levels compared with the natural cycle. An advantage for prevention of MRM in CHC users is that the hormone withdrawal is predictable. It is unknown, whether the attacks during the hormone-free interval are associated with the hormone withdrawal or onset of bleeding. Improved understanding of this relation might contribute to better define and shorten the time interval for prevention. METHODS: For this prospective diary-based trial we collected migraine and bleeding data from CHC users with MRM in at least two of three cycles. We analyzed frequency of migraines over the whole CHC cycle. During the hormone-free phase the relation between onset of migraine and onset of bleeding was studied. We compared pain intensity and identified prolonged-migraine attacks during hormone use and the hormone-free phase. RESULTS: During the hormone-free interval the number of migraine days and the pain score/migraine day were significantly higher in comparison with the mean during hormone use. The prevalence of migraine attacks was fourfold on hormone-free days 3-6. Migraine typically started on days 1-4. Migraine in relation to bleeding mostly occurred on days - 1 to + 4. In 78% of the cycles the first migraine day occurred during bleeding days 1 ± 2 and 48% started on days - 1 and day 1. The predictability of the first bleeding day was very high. CONCLUSION: The day of hormone-withdrawal migraine and the first bleeding day are highly predictable in CHC users. Migraine onset is mostly day - 1 and 1 of the bleeding and on days 1-4 of the hormone-free interval. Migraine attacks of CHC users in the hormone-free interval are severe and long lasting. Further trials are necessary to investigate if this knowledge can be used to optimise prevention.

Migraine, low-dose combined hormonal contraceptives, and ischemic stroke in young women: a systematic review and suggestions for future research.

Introduction: Migraine and combined hormonal contraceptives (CHCs) increase the risk of ischemic stroke in young women; however, the contribution of low-dose (<50 µg ethinylestradiol) CHCs to the risk of ischemic stroke in young women with migraine is not well defined.Areas covered: The authors performed a systematic review of observational studies indexed in PubMed and Scopus from inception to 22 May 2019, reporting the effect sizes of ischemic stroke in women with migraine using low-dose CHCs compared with those without migraine not using CHCs. All the four included case-control studies, including a total of 12,256 women, reported increased odds of ischemic stroke in women with migraine and low-dose CHC use compared with those without migraine not using CHCs. A meta-analysis was not feasible due to significant heterogeneity.Expert opinion: Strong data on the joint effect of migraine and CHC use on risk of ischemic stroke are lacking especially referring to the role of aura and headache frequency. Evidence suggests that the association with ischemic stroke is driven by migraine with aura. More robust data are needed to assess whether CHCs remain viable for women with migraine without aura, and whether their use could extend to some women with migraine with aura.

Effect of desogestrel 75 µg on headache frequency and intensity in women with migraine: a prospective controlled trial.

Objective: In contrast with combined hormonal contraception, progestin-only contraception is not associated with an increase in venous thromboembolism or stroke. Women with migraine are at increased risk of ischaemic stroke. Several studies have reported a reduction in migraine frequency and intensity with desogestrel 75 µg, a progestin-only pill. At present the quality of data is limited by retrospective study designs, lack of control groups and small sample sizes. We present the first prospective nonrandomised controlled trial. Methods: A total of 150 women with migraine visiting our clinic for contraceptive counselling were screened. The intervention group comprised women who opted for contraception with desogestrel (n = 98); the control group comprised women who continued their usual contraceptive (n = 36). Participants completed daily diaries for 90 days before the intervention and 180 days after the intervention. Results: In the intervention group, we found improvements in migraine frequency (p < .001), migraine intensity (p < .001) and the number of triptans used (p < .001). These improvements were already significant after 90 days of desogestrel use (p < .001). Disability scores also decreased significantly. No improvement was seen in the nonintervention group. Conclusion: These data demonstrate for the first time in a prospective controlled setting that daily use of the progestin desogestrel is associated with a decrease in migraine frequency, migraine intensity and pain medication use in women with migraine, with and without aura, who had previously been experiencing at least three days of migraine per month. Trial registration: The study is registered in the University of Zürich database ( www.research-projects.uzh.ch/unizh.htm ).

Contraceptive drugs mitigate experimental stroke-induced brain injury.

AIMS: Effective stroke treatments beyond reperfusion remain scant. The natural steroid hormone progesterone has shown protective effects in experimental models of brain injury and cardiovascular disease. However, unfavourable bioavailability limits its clinical use. Desogestrel and drospirenone are new generation progestins with progesterone-like properties, developed as oral contraceptives with excellent bioavailability and safety profile. We investigated the neuroprotective properties of these progestins in vivo using transient middle cerebral artery occlusion (MCAO) and in vitro using an oxygen-glucose deprivation and reoxygenation (OGD/R) model in primary neuronal cells. METHODS AND RESULTS: MCAO was induced in female, female ovariectomized (modelling postmenopausal females) and male mice. Treatment with the progestins resulted in less severe strokes after MCAO and less neuronal death in OGD/R. Desogestrel and drospirenone induced higher expression levels of GABAAR α4 and delta subunits within the brain, suggesting changes in GABAAR configuration favouring tonic inhibition as potential mechanism of action. Treatment with the GABAAR blocker picrotoxin abolished the protection afforded by the progestins in vivo and in vitro. CONCLUSION: For the first time, here, we delineate a potential role of desogestrel and drospirenone, both clinically approved and safe drugs in mitigating the consequences of stroke. Contraception with desogestrel and drospirenone in progestin-only preparations may be particularly beneficial for women at risk of stroke.

Effect of exogenous estrogens and progestogens on the course of migraine during reproductive age: a consensus statement by the European Headache Federation (EHF) and the European Society of Contraception and Reproductive Health (ESCRH).

We systematically reviewed data about the effect of exogenous estrogens and progestogens on the course of migraine during reproductive age. Thereafter a consensus procedure among international experts was undertaken to develop statements to support clinical decision making, in terms of possible effects on migraine course of exogenous estrogens and progestogens and on possible treatment of headache associated with the use or with the withdrawal of hormones. Overall, quality of current evidence is low. Recommendations are provided for all the compounds with available evidence including the conventional 21/7 combined hormonal contraception, the desogestrel only oral pill, combined oral contraceptives with shortened pill-free interval, combined oral contraceptives with estradiol supplementation during the pill-free interval, extended regimen of combined hormonal contraceptive with pill or patch, combined hormonal contraceptive vaginal ring, transdermal estradiol supplementation with gel, transdermal estradiol supplementation with patch, subcutaneous estrogen implant with cyclical oral progestogen. As the quality of available data is poor, further research is needed on this topic to improve the knowledge about the use of estrogens and progestogens in women with migraine. There is a need for better management of headaches related to the use of hormones or their withdrawal.

Correction to: Hormonal contraceptives and risk of ischemic stroke in women with migraine: a consensus statement from the European Headache Federation (EHF) and the European Society of Contraception and Reproductive Health (ESC).

Following the publication of this article [1], the authors noticed that they incorrectly reported the Absolute risk of ischemic stroke in women aged 20 to 44 years in relation to the use of hormonal contraception and migraine status due to a miscalculation. They apologize for this misreported result.

Effectiveness of the progestin-only pill for migraine treatment in women: A systematic review and meta-analysis.

Background Migraine is highly prevalent in women (18%). Peak morbidity affects their most productive years, coinciding with peak fertility. Hormonal contraception is often tailored for migraine prevention. Estrogen-containing contraceptives may be contraindicated in women experiencing migraine with aura due to the risk of vascular events. While improvements in migraine with a progestin-only pill (POP), which inhibits ovulation are documented, the strength and quality of evidence has not been formally evaluated. Objectives To determine the effectiveness of progestin-only contraceptives for migraine treatment by systematic review and meta-analysis. Data sources and selection MEDLINE, EMBASE and Cochrane Libraries were searched (1980 to September 2016) for studies on progestin-only treatments for migraine. Studies in English on >4 non-menopausal women aged 18-50 with migraine diagnosed by formal criteria were included. Data extraction and analysis Data were quality-assessed using the GRADE system. A random effects model was used for pooled analyses. Results Pooled analyses of four studies demonstrated that desogestrel 75 mcg/day, POP significantly but modestly reduced the number of migraine attacks and migraine days. Reduced intensity and duration, reduced analgesic and triptan use were observed, along with improved headache-related quality of life. GRADE analysis indicated evidence was low to very low for each outcome measure. Adverse effects resulted in treatment cessation for <10% of participants. Two studies compared desogestrel POP to a combined oral contraceptive, demonstrating similar migraine outcomes for both treatments. Conclusions The desogestrel POP shows promise in improving migraine in women. Current evidence is observational and based on small samples of women using only one oral progestin-only formulation. Further randomized trials on additional progestin-only contraceptives are required to confirm their role in migraine management.

Hormonal contraceptives and risk of ischemic stroke in women with migraine: a consensus statement from the European Headache Federation (EHF) and the European Society of Contraception and Reproductive Health (ESC).

Several data indicate that migraine, especially migraine with aura, is associated with an increased risk of ischemic stroke and other vascular events. Of concern is whether the risk of ischemic stroke in migraineurs is magnified by the use of hormonal contraceptives. As migraine prevalence is high in women of reproductive age, it is common to face the issue of migraine and hormonal contraceptive use in clinical practice. In this document, we systematically reviewed data about the association between migraine, ischemic stroke and hormonal contraceptive use. Thereafter a consensus procedure among international experts was done to develop statements to support clinical decision making, in terms of cardiovascular safety, for prescription of hormonal contraceptives to women with migraine. Overall, quality of current evidence regarding the risk of ischemic stroke in migraineurs associated with the use of hormonal contraceptives is low. Available data suggest that combined hormonal contraceptive may further increase the risk of ischemic stroke in those who have migraine, specifically migraine with aura. Thus, our current statements privilege safety and provide several suggestions to try to avoid possible risks. As the quality of available data is poor further research is needed on this topic to increase safe use of hormonal contraceptives in women with migraine.

Temporal relations in hormone-withdrawal migraines and impact on prevention- a diary-based pilot study in combined hormonal contraceptive users.

BACKGROUND: Menstrually related migraine (MRM) in the hormone-free interval (HFI) of combined hormonal contraceptives (CHC) are according to the ICHD definition also estrogen withdrawal migraines (EWH). MRMs are less responsive to acute medication. Therefore short-term prevention, initiated 1-2 days before onset of the anticipated bleeding and continued for 6 days, is recommended. Such a long prophylactic triptan use might increase the risk for medication overuse headache in women suffering in addition from non-menstrual migraines. In CHC users onset of hormone decline is predictable. It is however unknown, whether the EWHs are rather associated with onset of hormone withdrawal or onset of bleeding. Improved understanding of this relation might contribute to better define and shorten the time interval for prevention. METHODS: For this observational diary-based pilot study we collected data from daily conducted headache diaries of CHC users with MRM in at least two of three cycles, visiting our clinic from 2009 to 2015. We analyzed frequency of migraines for each hormone free day, onset of migraine, onset of bleeding and the relation of migraine to onset of bleeding in the 7-day period following estrogen withdrawal. We identified in addition the onset of migraine attacks lasting more than 1 day (episodes). RESULTS: Forty patient charts met the inclusion criteria, what allowed us to analyze 103 cycles. The mean number of migraine days in the HFI was 2.2 ± 1.6. Migraine started typically on days 1-5 and bleeding on days 3-5. In relation to first day of bleeding, migraines started on days -1 to 4. Almost half of the migraine attacks lasted longer than 24 h, despite the use of rescue medication. CONCLUSION: MRM in CHC users starts on bleeding days -1 to 4, what differs from findings in the natural cycle. Referring to the HFI interval migraine started mostly on days 1-5. According to these data, it seems to be reasonable to initiate short-term prevention at the last day of pill use or the first day of the HFI and continue for 5 days.

Improvement of migraine with change from combined hormonal contraceptives to progestin-only contraception with desogestrel: How strong is the effect of taking women off combined contraceptives?

Migraine is a disabling headache disorder, which affects up to 17% of the female population. Oestrogen withdrawal during the menstrual cycle or the hormone-free interval in users of combined hormonal contraceptives (CHC) plays a pivotal role. Two diary-based studies demonstrated a positive impact of the progestin-only pill (POP) desogestrel 75 µg on the frequency of the migraine attacks and pain intensity. In both studies, CHC users as well as nonusers were included, which makes it difficult to distinguish between the effect of taking women off the CHC and the benefit of the POP itself. With the present study, we compared the therapeutic effect of the POP desogestrel 75 µg on migraine in current CHC users and nonusers. We found a positive influence of desogestrel on migraine not only in women who switched from CHCs to desogestrel, but also in those who had not used hormones over 6 months before starting it. Our findings need to be confirmed in prospectively conducted studies with larger sample size.

Proposal to inform European institutions regarding the regulation of conscientious objection to abortion.

The aim of this paper is to define a set of proposals to inform European institutions in the regulation of Conscientious Objection to abortion. The board of the European Society of Contraception and Reproductive Health Care (ESC) was informed on the elements that should in the opinion of the authors be included in a future regulation of Conscientious Objection to abortion in Europe. These elements are outlined in this paper and the debate about them could form the basis for recommendations to the international scientific community and the European institutions. As current measures governing the principle of conscientious objection result in negative consequences regarding women's access to sexual and reproductive health services, they should be changed. Healthcare services should adopt measures to guarantee that a woman's right to voluntary abortion is not limited by the practitioner's stance on the principle of conscientious objection. In the countries where conscientious objection is allowed, the regulation must clearly delineate the extent of the duties and the exemptions of professionals based on the principles of established social consensus. The recommendations included in this document specify measures on the rights of women, the rights and duties of the practitioner, the role of institutions and the role of professional associations.

Positive effects of the progestin desogestrel 75 µg on migraine frequency and use of acute medication are sustained over a treatment period of 180 days.

BACKGROUND: Premenopausal migraines frequently are associated with fluctuations of estrogen levels. Both, migraine and combined hormonal contraceptives (CHC) increase the risk of vascular events. Therefore progestagen-only contraceptives (POC) are a safer alternative. A previous short-term study demonstrated a positive impact of the oral POC desogestrel on migraine frequency. To study the effect of the POC desogestrel 75 µg on migraine frequency, intensity, use of acute medication and quality of life in a clinical setting over the period of 180 days. METHODS: Patients' charts were screened for women with migraine, who had decided to use desogestrel for contraception. Charts were included, if routinely conducted headache diaries were complete for 90 days before treatment (baseline) and over a treatment period of 180 days. We also report about starters who stopped treatment early, because of adverse events. Baseline data (day 1-90 before treatment) were compared with first and second treatment period (treatment days 1-90 and days 91-180). Quality of life was evaluated using MIDAS questionnaires. RESULTS: Days with migraine (5.8 vs 3.6), with any kind of headache (9.4 vs 6.6), headache intensity (15.7 vs 10.7), days with severe headache (5.4 vs 2.4) and use of triptans (12.3 vs7.8) were significantly reduced after 180 days. MIDAS score and grade improved significantly. CONCLUSION: Contraception with desogestrel 75 µg resulted in a significantly improved quality of life and a reduction of migraine days over the observation period of 180 days. A clinically meaningful 30% reduction in pain was observed in 25/42 (60%) participants. For counselling reasons it is of importance, that the major reduction in migraine frequency occured during the initial 90 days, however further improvement occurs with longer duration of use. Prospective studies are needed to confirm these results.

European society of contraception statement on contraception in obese women.

The obesity 'epidemic' continues to increase, mostly but not only in developed countries. As overweight and obese women are at an increased risk for venous thromboembolism (VTE) at baseline and at a much higher risk during pregnancy, it is essential to help these women to plan pregnancies carefully and to use contraceptives with a positive ratio of benefits versus risks. The Expert Group on hormonal and molecular contraception of the European Society of Contraception convened to review the existing evidence and propose recommendations to the prescribers in line with most recent studies and with the Medical Eligibility Criteria of the World Health Organisation.

Randomized comparison of bleeding patterns in women using a combined contraceptive vaginal ring or a low-dose combined oral contraceptive on a menstrually signaled regimen.

OBJECTIVES: To compare bleeding patterns for 12 months continuous use of a contraceptive ring [contraceptive vaginal ring (CVR)] and pill [combined oral contraceptive (COC)] on a menstrually signaled regimen and the effectiveness of 4 days "treatment withdrawal" to stop bleeding. STUDY DESIGN: Women, 66 to each group, were randomized to continuous use of a CVR (15 mcg ethinyl estradiol/150 mcg etonogestrel) or a low-dose pill (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for 360 days on a menstrually signaled regimen. Bleeding/spotting days, daily use of ring or pill, was recorded. Endpoint was the total number of bleeding/spotting days for each method over four 90-day reference periods (RP) plus the analysis of bleeding patterns using modified World Health Organization criteria. RESULTS: There was a reduction in the mean (±S.D.) number of bleeding/spotting days from RP1 (CVR 14.2±10; pill 16.6±10.9) to RP4 (CVR 8.8±9.6; pill 8.8±9.1). Fifteen percent of CVR and 4% COC users experienced amenorrhea or infrequent bleeding throughout the study. Amenorrhea increased over time (RP1 vs. RP4: CVR 10% vs. 21% and COC 2% vs. 30%). Compliance with the menstrually signaled regimen was poor. Ceasing hormones for 4 days stopped a bleeding episode within 5 days in the majority of episodes and many stopped spontaneously. CONCLUSION: Bleeding patterns with continuous use of the CVR and COC are similar and improve over 1 year of use. The unpredictability, but short duration, of bleeding episodes should be stressed during counseling. IMPLICATION: This information for clinicians and women about breakthrough bleeding patterns with use of a CVR or combined pill over 12 months using a menstrually signaled regimen will give women an indication of what to expect with continuous use.