Prolonged use of nomegestrol acetate and risk of intracranial meningioma: a population-based cohort study.

Background: Nomegestrol acetate (NOMAC) is a synthetic potent progestogen. This study aimed to assess the risk of intracranial meningioma associated with the prolonged use of NOMAC. Methods: Observational cohort study using SNDS data (France). Women included had ≥ one dispensing of NOMAC between 2007 and 2017 (no dispensing in 2006). Exposure was defined as a cumulative dose >150 mg NOMAC within six months after first dispensing. A control group of women (cumulative dose ≤150 mg) was assembled. The outcome was surgery (resection or decompression) or radiotherapy for one or more intracranial meningioma(s). Poisson models assessed the relative risk (RR) of meningioma. Findings: In total, 1,060,779 women were included in the cohort (535,115 in the exposed group and 525,664 in the control group). The incidence of meningioma in the two groups was 19.3 and 7.0 per 100,000 person-years, respectively (age-adjusted RRa = 2.9 [2.4-3.7]). The RRa for a cumulative dose of more than 6 g NOMAC was 12.0 [9.9-16.0]. In the event of treatment discontinuation for at least one year, the risk of meningioma was identical to that in the control group (RRa = 1.0 [0.8-1.3]). The location of meningiomas in the anterior and middle part of the skull base was more frequent with exposure to NOMAC. Interpretation: We observed a strong dose-dependent association between prolonged use of NOMAC and the risk of intracranial meningiomas. These results are comparable to those obtained for cyproterone acetate, although the magnitude of the risk is lower. It is now recommended to stop using NOMAC if a meningioma is diagnosed. Funding: The French National Health Insurance Fund (Cnam) and the French National Agency for Medicines and Health Products Safety (ANSM) via the Health Product Epidemiology Scientific Interest Group EPI-PHARE.

Use of progestogens and the risk of intracranial meningioma: national case-control study.

OBJECTIVE: To assess the risk of intracranial meningioma associated with the use of selected progestogens. DESIGN: National case-control study. SETTING: French National Health Data System (ie, Système National des Données de Santé). PARTICIPANTS: Of 108 366 women overall, 18 061 women living in France who had intracranial surgery for meningioma between 1 January 2009 and 31 December 2018 (restricted inclusion periods for intrauterine systems) were deemed to be in the case group. Each case was matched to five controls for year of birth and area of residence (90 305 controls). MAIN OUTCOME MEASURES: Selected progestogens were used: progesterone, hydroxyprogesterone, dydrogesterone, medrogestone, medroxyprogesterone acetate, promegestone, dienogest, and intrauterine levonorgestrel. For each progestogen, use was defined by at least one dispensation within the year before the index date (within three years for 13.5 mg levonorgestrel intrauterine systems and five years for 52 mg). Conditional logistic regression was used to calculate odds ratio for each progestogen meningioma association. RESULTS: Mean age was 57.6 years (standard deviation 12.8). Analyses showed excess risk of meningioma with use of medrogestone (42 exposed cases/18 061 cases (0.2%) v 79 exposed controls/90 305 controls (0.1%), odds ratio 3.49 (95% confidence interval 2.38 to 5.10)), medroxyprogesterone acetate (injectable, 9/18 061 (0.05%) v 11/90 305 (0.01%), 5.55 (2.27 to 13.56)), and promegestone (83/18 061 (0.5%) v 225/90 305 (0.2 %), 2.39 (1.85 to 3.09)). This excess risk was driven by prolonged use (≥one year). Results showed no excess risk of intracranial meningioma for progesterone, dydrogesterone, or levonorgestrel intrauterine systems. No conclusions could be drawn concerning dienogest or hydroxyprogesterone because of the small number of individuals who received these drugs. A highly increased risk of meningioma was observed for cyproterone acetate (891/18 061 (4.9%) v 256/90 305 (0.3%), odds ratio 19.21 (95% confidence interval 16.61 to 22.22)), nomegestrol acetate (925/18 061 (5.1%) v 1121/90 305 (1.2%), 4.93 (4.50 to 5.41)), and chlormadinone acetate (628/18 061 (3.5%) v 946/90 305 (1.0%), 3.87 (3.48 to 4.30)), which were used as positive controls for use. CONCLUSIONS: Prolonged use of medrogestone, medroxyprogesterone acetate, and promegestone was found to increase the risk of intracranial meningioma. The increased risk associated with the use of injectable medroxyprogesterone acetate, a widely used contraceptive, and the safety of levonorgestrel intrauterine systems are important new findings.

Post-traumatic stress disorders in women victims-survivors of intimate partner violence: a mixed-methods pilot study in a French coordinated structure.

OBJECTIVES: This study aimed to examine the prevalence of post-traumatic stress disorder (PTSD) in victims-survivors of intimate partner violence (IPV) consulting at the specialised and original facility 'Maison des Femmes' (MdF) or in two close municipal health centres (MHCs). DESIGN: A mixed-methods study using a convergent parallel design from July 2020 to June 2021. SETTING/PARTICIPANTS: A questionnaire was proposed to women aged 18 years and over having suffered from IPV, in the MdF and in two MHCs. We also conducted qualitative interviews with a subsample of the women, asking for victim-survivors' perceptions of the effect of the MdF's care. PRIMARY AND SECONDARY OUTCOME MEASURES: The presence of a PTSD using the PTSD self-report checklist of symptoms, possibility of reaching women by phone 6 months after the inclusion visit, level of self-rated global health, number of emergency visits in the past 6 months, substances use, readiness to change and safety behaviours. RESULTS: A total of 67 women (mean age: 34 years (SD=9.7)) responded to our questionnaire. PTSD diagnosis was retained for 40 women (59.7%). Around 30% of participants self-rated their global health as bad. Less than 30% (n=18) of women were regular smokers, and only 7.5% of participants had a problematic alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4), 19.4% women used psychotropic drugs. Six months after inclusion, half of participants had been reached by phone. Analysis of the qualitative interviews clarified victim-survivors' perceptions of the MdF's specific care: social networking, multidisciplinary approach, specialised listening, healthcare facilities, evasion and 'feeling at home'. CONCLUSIONS: The high prevalence of PTSD at inclusion was nearly the same between the three centres. This mixed-methods comparison will serve as a pilot study for a larger comparative trial to assess the long-term impact of the MdF's specialised care on victims-survivors' mental health, compared with the care of uncoordinated structures. TRIAL REGISTRATION NUMBER: NCT04304469.

Impact of coronavirus disease 2019 on contraception use in France.

To limit the spread of the coronavirus disease 2019 (COVID 19), sanitary restrictions have been established since March 2020 in France. These restrictions and the waves of contamination may have had consequences on the use of health products in general, and on the use of contraceptives in particular. We aimed to assess the impact of COVID 19 pandemic from March 16th 2020 to April 30th 2021 in France on reimbursed contraceptives. We analyzed data from the French national health insurance database (SNDS) by extracting all oral contraception (OC), emergency contraception (EC), levonorgestrel-intrauterine system (LNG-IUS), copper-intrauterine device (C-IUD) and contraceptive implant dispensations in 2018, 2019, 2020 and to April 30th 2021. We computed the expected use of contraceptives in 2020 and 2021 without pandemic and its associated sanitary restrictions, by taking the annual trend into account. We assessed the evolution of dispensations by type of contraceptive and by age-groups (≤25 years old, between 25 and 35 and >35 years old) between observed and expected dispensations. After 15 months of pandemic, a decrease of all reimbursed contraceptives dispensations had been estimated, compared with what was expected: -2.0% for OC, -5.0% for EC, -9.5% for LNG-IUS, -8.6% for C-IUD, -16.4% for implant. Women under 25 years old were the most impacted by the decrease. This national study showed that the impact of the COVID 19 crisis was global on all reimbursed contraceptives, with different levels of impact depending on the type of contraceptive, the age-group and the severity of the restriction. OC dispensing decreased marginally compared with expectations. The decrease in long-acting contraceptives dispensing was more pronounced, especially for the implant. These results call for continued monitoring of contraceptive use over the long term and for prioritizing access to sexual health services during crises, especially among the youngest women who were most affected in this study.

Association between the experience of sexual violence and insomnia in a national sample of French adults.

PURPOSEL: The experience of sexual violence has been associated with sleeping disorders; however, few studies have examined this association using a large sample of the general population. This study investigates whether lifetime experience of sexual violence and childhood experience of sexual violence are associated with insomnia. METHODS: Our study is based on data from the 2017 French Health Barometer, a general population phone cross-sectional survey, which included 25 319 adults aged 18-75 years in 2017. Questions regarding sleep quality were asked to 12 560 participants, and insomnia was defined according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). We conducted adjusted Log-binomial regressions to examine the association between the experience of sexual violence and insomnia by calculating adjusted Prevalence Ratios (PRa; 95% CI). RESULTS: The weighted prevalence of insomnia was 13.5%, with women more affected than men (17.9% vs 9.6%). The prevalence of lifetime experience of sexual violence was around 3 times higher among those who suffer from insomnia (12.3%) compared to those who do not (4.5%). The adjusted associations between lifetime experience of sexual violence and insomnia, as well as between childhood experience of sexual violence and insomnia were both statistically significant (PRa = 1.79; 95% CI: 1.59-2.02; and PRa = 1.42; 95% CI: 1.23-1.64 respectively). CONCLUSIONS: Sexual violence could explain the substantial sex-difference in insomnia. Our findings reiterate the importance of systematically screening for sexual violence among patients suffering from sleep disorders to propose adequate trauma-informed interventions.

Association Between Doses of Levonorgestrel Intrauterine Systems and Subsequent Use of Psychotropic Drugs in France.

This matched-cohort study uses data from the French National Health Insurance database to assess whether a 19.5-mg levonorgestrel intrauterine system, vs a 52-mg system, is associated with increased use of antidepressant, hypnotic, and anxiolytic medications.

Profiles of copper intrauterine devices and levonorgestrel intrauterine systems users in France in 2019: A national observational population-based study.

OBJECTIVE: To assess the user profiles of copper intrauterine devices (Cu-IUD) and levonorgestrel intrauterine systems (LNG-IUS) in France in 2019 and the rates of continuation 1 year later. METHODS: A population-based study was conducted of all French women aged 13-49 years for whom an IUD was dispensed in 2019. Information was collected from the French National Health Data System about their characteristics at the time of dispensation and indicators of continued use 1 year later. Associations between these characteristics and the type of IUD were analyzed using multivariate regressions. RESULTS: A total of 477 705 Cu-IUDs and 355 242 LNG-IUSs (mean age 32.5 ± 7.3 and 36.4 ± 7.7 years, respectively) were dispensed in 2019. After adjustment, having a LNG-IUS rather than a Cu-IUD was associated with being aged 35-44 years compared to 25-35 years (odds ratio [OR35-44 ] 2.03, 95% confidence interval [CI] 2.01-2.05), having a prescription by a gynecologist rather than a general practitioner (OR35-44 1.09, 95% CI 1.08-1.11), and having a gynecological history (OR35-44 2.28, 95% CI 2.20-2.36). The continuation rates 1 year after dispensation were 86.4% for Cu-IUD versus 85.7% for LNG-IUS. A Cu-IUD dispensation rather than a LNG-IUS one was associated with a higher chance of continued use 1 year later. CONCLUSION: Two different patterns of use of Cu-IUDs and LNG-IUSs in France are highlighted.

Violence against women and perceived health: An observational survey of patients treated in the multidisciplinary structure 'The Women's House' and two Family Planning Centres in the metropolitan Paris area.

It is unknown how many women seeking care at French Family Planning Centres (FPCs) endure, or have endured intimate partner violence (IPV). To assess the prevalence of IPV, we surveyed women seeking care at three FPCs in the metropolitan Paris area (Seine-Saint-Denis). We examined the associations between IPV, socio-demographic characteristics and perceptions of health according to six indicators. Of the FPCs included in our survey, two are standalone facilities and one is located in The Women's Home, a multidisciplinary structure dedicated to serving survivors of violence. We conducted an observational survey from December 2018 to February 2019. All women aged 18 years and older were eligible. We solicited data on socio-demographic factors, general stability and history of violence. We measured health status on a 10-point scale for six different symptoms. Of the 274 women who participated, 27% had experienced IPV. Women who reported experiencing, or having experienced IPV were more likely to be between 25 and 44 years old (than under 25), temporarily documented or undocumented, unemployed or seeking employment, and experiencing housing insecurity. Women seeking care at The Women's House were more than twice as likely to report IPV (42%) than those visiting FPC-2 or FPC-3 (20% and 16%, respectively). Reports of violence increase among women with uncertain legal status, housing, employment and lower self-rated health. Results suggest that a FPC located in a structure specifically dedicated to serving women victims-survivors of violence like the Women's House may be more attractive to survivors.

Impact of Coronavirus disease 2019 (COVID-19) on contraception use in 2020 and up until the end of April 2021 in France.

OBJECTIVES: To assess the impact of the COVID-19 pandemic on the use of reimbursed contraceptives in France after 15 months of the pandemic, according to age-group and updating previous data only pertaining to the first lockdown (2 months). STUDY DESIGN: We conducted a national register-based study by extracting all reimbursements of oral contraceptives (OC), emergency contraception (EC), intrauterine devices (IUD), and implants from the French National Health Insurance database (SNDS), which includes and covers 99.5% of the French population, in 2018, 2019, 2020 and from January 1, 2021 to April30, 2021. We calculated the expected use of contraceptives in 2020 and 2021 in the absence of the pandemic, based on 2018 and 2019 usage and taking annual trends into account. We assessed the difference between observed and expected dispensing rates by contraceptive type and by age-group (≤18 years old, 18< age ≤25, 25< age ≤35, >35). RESULTS: Dispensing of all contraceptives decreased compared to expect dispensing numbers: -2.0% for OC, -5.3% for EC, -9.5% for LNG-IUS, -8.6% for C-IUD, and -16.4% for implant. This decrease in the dispensing of contraceptives was observed in all age-groups, but mainly concerned women under the age of 18 years (-22% for OC, -10% for EC, -37.2% for LNG-IUS, -36.4% for C-IUD, -26.4% for implant) and those aged 18 to 25 (-5.1% for OC, -11.9% for EC, -18.1% for LNG-IUS, -15.9% for C-IUD, -17.6% for implants). CONCLUSIONS: Our study showed that the dispensing of contraceptives in France was markedly impacted by the COVID-19 pandemic. Prescriptions for long-acting contraceptive use and women under the age of 25 years were the most substantially impacted. Ensuring access to contraceptive methods during health emergencies must be a public health policy priority. IMPLICATIONS: The COVID-19 pandemic strongly impacted the dispensing of contraceptives in France with varying degrees of decreased dispensing according to the type of contraceptive, the age-group and the level of pandemic-related restrictions. The impact of these restrictions on unintended pregnancy at the population level remains undetermined.

Witnessing interparental violence in childhood and symptoms of depression in adulthood: data from the 2017 French Health Barometer.

BACKGROUND: Every year, it is estimated that 143 000 French children are exposed to interparental violence (IPV). This exposure may have deleterious lifelong impact on mental health. OBJECTIVE: To investigate the associations between exposure to IPV in childhood and, as adults, the presence of depressive symptoms during the past year, suicidal thoughts and lifetime suicide attempt. METHODS: Our study is based on data from the 2017 French Health Barometer, a general population cross-sectional phone survey. 25 319 adults living in Metropolitan France responded. Data were weighted to obtain a representative sample of the French population. Associations between childhood exposure to IPV and each of three outcomes in adulthood-symptoms of depression, suicidal ideation in the past year and lifetime suicide attempt-were studied by calculating odds ratios (ORs) and their 95% confidence intervals (CIs), stratifying by sex and using multivariate models (logistic regression). RESULTS: After adjustment for age, social variables, negative life events in childhood and lifetime history of sexual violence, reporting witnessed IPV is significantly associated with the presence of symptoms of depression during the past 12 months (aORmen = 1.88, 95% CI = 1.49-2.38, and aORwomen = 2.00, 1.72-2.32), suicidal thoughts in the past 12 months (aORmen = 1.97, 1.48-2.64, and aORwomen = 2.35, 1.89-2.93), and at least one lifetime suicide attempt (aORmen =2.39, 1.83-3.11 and aORwomen = 2.66, 2.25-3.16). CONCLUSION: Associations shown between a history of exposure to IPV and three mental health indicators in adulthood underline the need to study the lifelong impact of IPV.