Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research to advance the health of people with inherited bleeding disorders with the potential to menstruate.

Background: People who have or had the potential to menstruate (PPM) with inherited bleeding disorders (BD) face particular challenges receiving appropriate diagnosis and care and participating in research. As part of an initiative to create a National Research Blueprint for future decades of research, the National Hemophilia Foundation (NHF) and American Thrombosis and Hemostasis Network conducted extensive all-stakeholder consultations to identify the priorities of PPM with inherited BDs and those who care for them.

Research Design And Methods: Working group (WG) 4 of the NHF State of the Science Research Summit distilled community-identified priorities for PPM with inherited BDs into concrete research questions and scored their feasibility, impact, and risk.

Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use.

Objective: To evaluate the efficacy and safety of a new, low-dose levonorgestrel intrauterine contraceptive system (LNG-IUS 12) for up to 5 years of use.

Study Design: In this Phase III study, 2885 nulliparous and parous women aged 18-35 years were randomized to LNG-IUS 8 or LNG-IUS 12 for 3 years. After 3 years, women using LNG-IUS 12 could continue for up to 2 additional years (5 years total).

A multicentre, open-label, randomised phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral contraception in young women of reproductive age.

Objectives: To compare user satisfaction and adverse events (AEs) with a levonorgestrel intrauterine system (LNG-IUS 8; average levonorgestrel release rate approximately 8 μg/24 h over the first year [total content 13.5 mg]) and a 30 μg ethinyl estradiol/3 mg drospirenone (EE/DRSP) combined oral contraceptive (COC) in a population of young women.

Methods: Nulliparous and parous women (aged 18-29 years) with regular menstrual cycles (21-35 days) were randomised to LNG-IUS 8 or EE/DRSP for 18 months.

The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial.

Objective: Two low-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs; total content 13.5 mg [average approx. 8 μg/24 hours over the first year; LNG-IUS 8] and total content 19.

Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system.

Objective: The aim of this study was to assess the presence of ovarian cysts in women using a new low-dose levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 13.5mg [total content]).

Study Design: A Phase 3 study assessed LNG-IUS 13.

EVAPIL-R Scale: Continuous development and validation of a tool to assess patient-reported tolerability of different contraceptive methods in longitudinal studies.

Objective: The objective of this study was to modify the EVAPIL, a questionnaire designed to assess user-reported tolerability of combined oral contraceptives (COCs) in cross-sectional studies, to make it appropriate for assessing the tolerability of intrauterine systems (IUSs), subdermal implants, and COCs in longitudinal studies.

Methods: Development of the EVAPIL-Revised (EVAPIL-R) was informed by a targeted literature review, qualitative interviews with IUS-prescribing gynecologists (n = 5), and IUS and implant users in the United States, Germany, and France (n = 36).

Results: Evidence generated supports the content validity of the EVAPIL-R for assessing user-reported tolerability of COCs, IUSs, and implants.

Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies.

Objective: To assess the pharmacokinetics and pharmacodynamics of levonorgestrel intrauterine system (LNG-IUS) 13.5 mg and LNG-IUS 19.5 mg (total content).

Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial.

Objective: To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems.

Methods: Nulliparous and parous women aged 18-35 years with regular menstrual cycles (21-35 days) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems: 13.5 mg total content or 19.

Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema.

Background: Hereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist.

Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.

Objective: To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon).