Unintended pregnancy in users of nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared with levonorgestrel-containing combined oral contraceptives: final results from the PRO-E2 study.

Objective: To assess and compare the risk of unintended pregnancy in NOMAC-E2 users with levonorgestrel-containing COC (COC) users in clinical practice.

Study Design: In this observational study, new users of NOMAC-E2 and COC were recruited in Europe, Australia, and Latin America and followed for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (contraceptive failures per 100 women-years [WY]), crude hazard ratios (HR) and adjusted hazard ratios (HR).

Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17β-oestradiol (1.5mg) (PRO-E2 study): risk of venous and arterial thromboembolism.

Objective: To assess and compare the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in NOMAC-E2 users with levonorgestrel-containing combined oral contraceptive (COCLNG) users.

Study Design: This large, prospective, observational active surveillance study used a non-inferiority design. New users of NOMAC-E2 and COCLNG were recruited in 12 countries in Australia, Europe, and Latin America.

Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena satisfaction study.

Purpose: The Kyleena Satisfaction Study (KYSS) aimed to assess satisfaction and continuation with levonorgestrel-releasing intrauterine system (LNG-IUS) 12 (Kyleena) in routine clinical practice and to evaluate factors that influence satisfaction.

Materials And Methods: This prospective, observational, multicentre, single-arm cohort study, with 1-year follow-up, was conducted in Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the United States from 2017 to 2018. During routine counselling, women who independently selected to use LNG-IUS 12 were invited to participate in the study.

Risk of depression and anemia in users of hormonal endometriosis treatments: Results from the VIPOS study.

Objective: Dienogest (DNG) 2 mg (Visanne) was launched for endometriosis treatment in Europe in 2010. The Visanne Post-approval Observational Study (VIPOS) was designed to assess the safety of DNG 2 mg/day compared to other hormonal endometriosis treatments, focusing especially on clinically relevant depression and anemia.

Study Design: Large, prospective, non-interventional, active surveillance study in six European countries.

Unintended pregnancy rates differ according to combined oral contraceptive - results from the INAS-SCORE study.

To estimate the real-use contraceptive effectiveness of the combined oral contraceptive (COC) containing dienogest and oestradiol valerate (DNG/oEV) compared to other combined oral contraceptives (oCOC) and particularly, levonorgestrel-containing OCs (LNG). Prospective, non-interventional cohort study with two main exposure groups and one exposure subgroup: new users of DNG/oEV and oCOC, with the subgroup, LNG. In a planned secondary analysis, pregnancy outcomes were investigated, including contraceptive failure.

Real world data on Nexplanon® procedure-related events: final results from the Nexplanon Observational Risk Assessment study (NORA).

Objectives: We conducted this study to characterize the frequency of insertion-, localization- and removal-related events and their clinically significant consequences among Nexplanon® (etonogestrel radiopaque contraceptive implant) users in the United States during standard clinical practice.

Study Design: The Nexplanon Observational Risk Assessment (NORA) study was a large, prospective cohort study conducted in the United States. A total of 428 Health Care Professionals (HCPs) who had completed the Nexplanon clinical training program recruited women who were newly prescribed Nexplanon.

Perforation risk and intra-uterine devices: results of the EURAS-IUD 5-year extension study.

Objectives: The objective of this analysis was to identify intra-uterine devices (IUD) perforations detected from 12 to 60 months following IUD insertion, and to combine this information with (our previously published) data about perforations detected in the first 12 months to calculate cumulative perforation rates.

Methods And Materials: Prospective, non-interventional cohort study with new users of levonorgestrel-releasing intra-uterine systems (LNG-IUS) and copper-IUD. The original cohort included 61,448 women followed for 12 months.

IUD use among parous women and risk of uterine perforation: a secondary analysis.

Objective: The objective of the study was to determine if delivery and lactation are risk factors for complete intrauterine device perforations.

Study Design: We performed a reanalysis of the European Active Surveillance Study on Intra-Uterine Devices data set using complete penetration of the myometrium as the definition for perforation.

Results: Of the 61,448 women enrolled (70% levonorgestrel, 30% copper devices), we identified 58 complete perforations, 30 of which occurred in lactating women.

Fertility and combined oral contraceptives - unintended pregnancies and planned pregnancies following oral contraceptive use - results from the INAS-SCORE study.

Objectives: To estimate the real-use contraceptive effectiveness of the combined oral contraceptive containing dienogest and estradiol valerate (DNG/EV) and whether DNG/EV compared to other combined oral contraceptives (oCOC) has a negative effect on return to fertility.

Methods: Transatlantic, prospective, non-interventional cohort study conducted in the USA and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). In a planned secondary analysis, pregnancy outcomes were investigated including contraceptive effectiveness and pregnancy following contraceptive cessation.

Impact of estrogen type on cardiovascular safety of combined oral contraceptives.

Objectives: The International Active Surveillance study "Safety of Contraceptives: Role of Estrogens" (INAS-SCORE) investigated the cardiovascular risks associated with the use of a combined oral contraceptive (COC) containing dienogest and estradiol valerate (DNG/EV) compared to established COCs in a routine clinical setting.

Study Design: Transatlantic, prospective, noninterventional cohort study conducted in the United States and seven European countries with two main exposure groups and one exposure subgroup: new users of DNG/EV and other COC (oCOC), particularly levonorgestrel-containing COCs (LNG). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents.

Drospirenone plus estradiol and the risk of serious cardiovascular events in postmenopausal women.

Objectives: To compare incidence rates of serious cardiovascular events, particularly arterial thromboembolic events (ATE), in users of hormone replacement therapy (HRT), particularly oral continuous combined preparations.

Methods: Prospective, controlled cohort study with four arms: women using (1) drospirenone (DRSP)/estradiol, (2) other oral continuous combined HRT (HRTcc), (3) all other oral HRTs, and (4) non-oral HRT. The study population consisted of women aged 40+ years in seven European countries who were new users of HRT at the time of inclusion.

Cardiovascular risks associated with the use of drospirenone-containing combined oral contraceptives.

Objectives: The "Long-term Active Surveillance Study for Oral Contraceptives" investigated the risks of long-term use of a 21-day regimen of drospirenone and ethinylestradiol (DRSP) compared to established oral contraceptives (OCs) in a routine clinical setting.

Study Design: Prospective, controlled, non-interventional cohort study conducted in seven European countries with three main exposure groups: new users of DRSP, levonorgestrel-containing OCs (LNG), and OCs containing other progestogens (Other OCs). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents.

Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives.

Objectives: The "International Active Surveillance Study of Women Taking Oral Contraceptives" investigated the risks of short- and long-term use of an extended 24-day regimen of drospirenone and ethinylestradiol (DRSP24d) compared to established oral contraceptives (OCs) in a routine clinical setting.

Study Design: Prospective, controlled, noninterventional cohort study conducted in the United States and six European countries with three main cohorts: new users of DRSP24d, DRSP21d (21-day regimens of DRSP-containing OCs), and non-DRSP (OCs without DRSP). All self-reported clinical outcomes of interest (OoI) were validated via attending physicians and relevant source documents.

Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring.

Objective: To compare the risks of short-term and long-term use of an etonogestrel-containing and ethinylestradiol-containing vaginal ring and combined oral contraceptive pills (OCPs) in a routine clinical study population.

Methods: This was a prospective, controlled, noninterventional cohort study performed in the United States and five European countries with the following two cohorts: new users of the vaginal ring and new users of combined OCPs (starters, switchers, or restarters). The study population included 33,295 users of the vaginal ring or combined OCPs recruited by 1,661 study centers.

Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer.

Background: This study compares the risk of breast cancer for levonorgestrel-releasing intrauterine devices (LNG(IUD)) versus copper IUDs (CU(IUD)) in women younger than 50 years of age.

Study Design: Retrospective, population-based, case-control study using cancer registers in Finland and Germany, powered to exclude a 1.5-fold risk of breast cancer.

Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen.

Objective: To estimate real-life effectiveness of oral contraceptive pills by progestogen, length of pill-free interval, and body mass index while focusing on the effect of progestogens with a long half-life and on 24-day oral contraceptive pills regimens.

Methods: Outcome data from 52,218 U.S.

Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study.

Objective: The primary objective of the study was to clarify whether the use of the oral contraceptive 2 mg dienogest/30 microg ethinylestradiol (DNG/EE) is associated with a higher risk of venous thromboembolism (VTE) than the use of other combined oral low-dose contraceptives (i.e. containing < or =30 microg EE), particularly oral contraceptives containing levonorgestrel (LNG).

Explorative evaluation of the impact of premenstrual disorder on daily functioning and quality of life.

Objectives: : To assess the effects of premenstrual disorders on health-related quality of life (HR-QOL), hobbies and social activities, and relationships with others in the multinational IMPACT study.

Methods: : Women aged 15-45 years were screened for suspected premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS) and invited to participate in this web-based study. Based on the Daily Record of Severity of Problems (DRSP), prospectively assessed over two observational cycles, participants were grouped into two categories: no perceived symptoms/mild PMS or moderate-to-severe PMS/PMDD.

Use of oral contraceptives containing gestodene and risk of venous thromboembolism: outlook 10 years after the third-generation "pill scare".

Background: This study investigated whether gestodene-containing oral contraceptives (OCs) carry a higher risk of venous thromboembolism (VTE) than OCs containing progestins other than desogestrel and gestodene. The study was conducted based on the hypothesis that the biases and confounding factors that were present initially after the introduction of new so-called "third-generation" OCs (i.e.