Pregnancy and pregnancy outcomes in a prospective cohort study: Final results from the Nexplanon Observational Risk Assessment Study (NORA).

Objectives: To monitor pregnancy occurrence and outcomes among Nexplanon 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 (US). Study participants with a newly inserted Nexplanon implant were recruited by health care professionals (HCPs) who had completed the Nexplanon clinical training.

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.

Optimization and characterization of electrospun polycaprolactone coated with gelatin-silver nanoparticles for wound healing application.

Bacterial infection and damage caused by dressing removal are two concerning problems which prolong the healing process in treatment of skin injuries. In this study, plasma treated electrospun polycaprolactone (PCL) scaffold was coated with silver nanoparticles (AgNPs) embedded in gelatin (Gel) by multi-immersion technique to optimize its antibacterial performance and reduce wound-scaffold adhesion. Water interaction test was used to examine the hydrophilization of PCL electrospun fibers after plasma treatment.

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.

Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices.

Objectives: The objectives were to identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems (LNG-IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users.

Methods And Materials: This is a multinational, prospective, non-interventional cohort study with new users of LNG-IUSs and copper IUDs. In addition to a baseline questionnaire, women and their treating health care professional completed a single follow-up questionnaire after 12 months.

Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices.

Objectives: The objective was to measure the rate of unintended pregnancies in women using levonorgestrel-releasing intrauterine systems (LNG IUSs, releasing 20 mcg LNG daily) and copper intrauterine devices (IUDs) in a typical population of IUD users and to describe associated complications.

Methods: A multinational, prospective, non-interventional cohort study of new users of LNG IUS and copper IUDs was performed. Following a baseline survey, study participants and their physicians completed one follow-up questionnaire after 12 months.

Intercountry assessment of the impact of severe premenstrual disorders on work and daily activities.

We explored the effects of premenstrual symptoms in women suffering from moderate-to-severe premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD) on work productivity, absenteeism, and daily life activities in a large, worldwide exploratory study. Women aged 15-45 years from 19 countries in North America, Latin America, Europe, Asia, and Australia were screened for suspected PMS and PMDD and invited to participate in this 2-month web-based survey. Overall, 4,032 women completed all administered questionnaires and represent the analysis set.

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.

Explorative evaluation of the impact of severe premenstrual disorders on work absenteeism and productivity.

Purpose: To assess the effects of premenstrual disorders on work productivity and absenteeism in the multinational Impact study.

Methods: Women aged 15-45 years were screened for suspected premenstrual dysphoric disorders (PMDD) and premenstrual syndrome (PMS) and invited to participate in this web-based study. Based on the Daily Record of Severity of Problems (DRSP) questionnaire, symptoms were assessed prospectively over 2 months.

Oral contraceptive effectiveness according to body mass index, weight, age, and other factors.

Objective: The purpose of this study was to assess the use-effectiveness of oral contraceptives (OCs) in Europe according to body mass index (BMI), weight, age, and other factors.

Study Design: In a planned secondary analysis, we used data from the European Active Surveillance Study on Oral Contraceptives, which was a prospective active cohort surveillance study of 59,510 OC users, to assess the effectiveness of OCs overall and by BMI, weight, age, duration of use, ethinylestradiol dose, regimen type, starting/switching status, and parity. Self-reported unplanned pregnancies during OC use were confirmed by interview.

Colon cancer risk and different HRT formulations: a case-control study.

Background: Most studies have found no increased risk of colon cancer associated with hormone replacement therapy (HRT), or even a decreased risk. But information about the effects of different HRT preparations is lacking.

Methods: A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers.

Breast cancer risk associated with different HRT formulations: a register-based case-control study.

Background: Previous epidemiological studies have inconsistently shown a modestly increased breast cancer risk associated with hormone replacement therapy (HRT). Limited information is available about different formulations--particularly concerning different progestins.

Methods: A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers.

The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study.

Background: The Menopause Rating Scale is a health-related Quality of Life scale developed in the early 1990s and step-by-step validated since then. No methodologically detailed work on the utility of the scale to assess health-related changes after treatment was published before.

Method: We analysed an open, uncontrolled post-marketing study with over 9000 women with pre- and post-treatment data of the MRS scale to critically evaluate the capacity of the scale to measure the health-related effects of hormone treatment independent from the severity of complaints at baseline.

The Aging Males' Symptoms scale (AMS) as outcome measure for treatment of androgen deficiency.

Introduction: No clinical study data in which the AMS scale was applied as outcome measure has been reported until today.

Method: An open post-marketing study was performed by office-based urologists in Germany in 2000/01. We analysed data of 1174 androgen-deficient males who were treated with testosterone enanthate.

The Aging Males' Symptoms (AMS) scale: review of its methodological characteristics.

Background: The current paper reviews data from different sources to get a closer impression on the psychometric and other methodological characteristics of the Aging Males' Symptoms (AMS) scale gathered recently. The scale was designed and standardized as self-administered scale to (a) to assess symptoms of aging (independent from those which are disease-related) between groups of males under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and post androgen replacement therapy. The scale is in widespread use (14 languages).