Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials.

Objective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes.

Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies.

Real world comparison of immune-related adverse events with nivolumab-relatlimab versus ipilimumab-nivolumab in patients with advanced cutaneous melanoma.

Introduction: Frontline therapy for patients with advanced cutaneous melanoma often includes immune checkpoint inhibitors (ICIs). Although these agents have increased response rates, many patients will experience immune-related adverse events (irAEs). The difference in safety profiles of the current combinations available are not well established.

The evolving perspective of menopause management in the United Kingdom.

Background: The use of menopausal hormone therapy (MHT) was significantly reduced following the publication of the Women's Health Initiative study results and has remained low ever since. However, from 2015 onwards, the UK has seen a substantial increase in MHT prescribing compared to other European countries.

Objectives: To evaluate the factors contributing to the shift in women's and healthcare professionals' (HCPs) perception of MHT in the United Kingdom and to provide learning points for other European countries.

A novel estetrol-containing combined oral contraceptive: European expert panel review.

Purpose: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation.

Materials And Methods: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination.

Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview.

Bleeding irregularities are one of the major reasons for discontinuation of oral contraceptives (OCs), and therefore clinicians need to set expectations during consultations. In this review we provide an overview of bleeding data of recently marketed cyclic combined OCs (COCs) and one progestin-only pill (POP). We evaluated data from phase 3 trials (≥12 months) used to gain regulatory approval.

A novel estetrol-containing combined oral contraceptive: European expert panel review.

Purpose: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation.

Materials And Methods: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination.

Recommendations for standardization of bleeding data analyses in contraceptive studies.

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contraceptive is designed to result in a predictable or unpredictable bleeding pattern.

Consensus-led recommendations supporting choice and personalisation of Hormone replacement therapy in menopause care.

Objective: Inequity of access and choice to different hormone replacement therapy (HRT) products across the UK has been suggested (Hillman, 2020). While, the cause is not entirely understood, potential contributors include conflicting national guidance, economic deprivation and a local formulary approach. With a diverse and growing population of women reaching and living well beyond the menopause, the impact of this inequity is becoming more pronounced, and challenges the goal of providing personalised care.

Copper IUD continuation, unwanted effects and cost consequences at 1 year in users aged under 30 - a secondary analysis of the EURAS-IUD study.

Objective: To conduct a secondary analysis of continuation, unwanted effects and cost consequences at 1 year in copper intrauterine device (IUD) users aged under 30 in the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD study) based on IUD type.

Methods: Descriptive and comparative analyses of copper IUD continuation, unwanted effects and estimated cost consequences at 1 year were performed in users aged under 30 based on IUD copper surface area, shape or design, width and arms' flexibility.

Results: 5796 copper IUD users were identified to have been aged under 30 at EURAS-IUD study recruitment and data for 5762 users (99.

A Review of Clinical Guidelines on the Management of Iron Deficiency and Iron-Deficiency Anemia in Women with Heavy Menstrual Bleeding.

Introduction: Up to one-third of women of reproductive age experience heavy menstrual bleeding (HMB). HMB can give rise to iron deficiency (ID) and, in severe cases, iron-deficiency anemia (IDA).

Aim: To review current guidelines for the management of HMB, with regards to screening for anemia, measuring iron levels, and treating ID/IDA with iron replacement therapy and non-iron-based treatments.

Best Practices for Counseling Adolescents about the Etonogestrel Implant.

Among young persons, ease of use, high efficacy, and high acceptability makes the etonogestrel contraceptive implant an important choice for this age group. Adolescent-friendly, patient-centered counseling considers the patient's cognitive development, the influence of friends and family, as well as their own preferences and values. Age-appropriate language, graphics, and models are useful to explain contraceptive options and relevant side effects.

Higher discontinuation rate with a standard-sized compared to a small-sized 'gold standard' copper intrauterine device: a case-control review.

Background: T-shaped intrauterine devices (IUDs) with a copper surface area of 380 mm and copper bands on the transverse arms are the most effective types of copper-containing IUDs. A small-sized 'gold standard' IUD is available but there has been little research to compare the effects of this small-sized IUD to its standard-sized counterpart.

Aim: To determine discontinuation rates and reasons for discontinuation at 1 year of the small-sized Mini TT380 Slimline IUD compared with the standard-sized TT380 Slimline.

Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

Objectives: To evaluate if a simple method for characterizing vaginal bleeding patterns in etonogestrel contraceptive implant users can predict subsequent patterns and bleeding-related discontinuation over the first 2 years of use.

Study Design: We reanalyzed phase 3 study bleeding data for non-breastfeeding participants from the United States, Europe, Russia and Chile during the first 2 years of implant use to characterize and correlate bleeding patterns. We used 90-day reference periods with period 1.

2018 American Society of Consultant Pharmacists Annual Meeting & Exhibition.

Poster abstracts are evaluated based on the following criteria: significance of the problem to healthy aging or medication management; innovativeness of ideas, methods, and/or approach; methodological rigor of methods and approach; presentation of finding; implications identified for future research, practice, and/or policy; and clarity of writing. Submissions are not evaluated through the peer-reviewed process used by . Industry support is indicated, where applicable.

Iron deficiency and iron deficiency anaemia in women.

Iron deficiency (ID) is the most common micronutrient deficiency worldwide with >20% of women experiencing it during their reproductive lives. Hepcidin, a peptide hormone mostly produced by the liver, controls the absorption and regulation of iron. Understanding iron metabolism is pivotal in the successful management of ID and iron deficiency anaemia (IDA) using oral preparations, parenteral iron or blood transfusion.

Pooled analysis of two randomized, open-label studies comparing the effects of nomegestrol acetate/17β-estradiol and drospirenone/ethinyl estradiol on bleeding patterns in healthy women.

Objectives: To obtain more precise and detailed information regarding the bleeding patterns of nomegestrol acetate (NOMAC)/17β-estradiol (E2) and drospirenone/ethinyl estradiol (DRSP/EE) and to identify whether baseline demographic characteristics were associated with unscheduled bleeding, absent scheduled bleeding, or amenorrhea.

Study Design: This analysis pooled results from two pivotal open-label, randomized trials that compared bleeding patterns of NOMAC/E2 and DRSP/EE. In the two studies 4317 women aged 18-50 years from 24 countries across the Americas, Europe, and Asia underwent treatment.

Intravascular migration of contraceptive implants: two more cases.

Cases: In addition to previously published case reports, further cases of intravascular migration of contraceptive implants have been identified from an information request to two national adverse reaction spontaneous reporting systems. We report on two new cases of insertion into the venous system with subsequent embolism to a pulmonary artery.

Conclusion: Incorporating barium sulfate into the implant has facilitated diagnosis of these very rare adverse events with the initial diagnosis of embolism to the pulmonary arterial tree made by chest X-ray.