Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device.

Objectives: This study aimed to assess 3-year efficacy, safety, and tolerability of the Cu 175 mm intrauterine device (IUD).

Study Design: This single-arm trial recruited participants at risk of pregnancy aged 17 to 45 years at 42 U.S.

Levonorgestrel 52 mg intrauterine device placement without uterine sounding: A feasibility study.

Objectives: To evaluate feasibility of levonorgestrel 52 mg intrauterine device (IUD) placement without uterine sounding.

Study Design: We performed a three-phase feasibility study from February 2023-May 2024. In phase one, participants had levonorgestrel 52 mg IUD placement with sounding.

Comparative efficacy of combined oral contraceptives and the levonorgestrel 52 mg IUD.

The relative risk of pregnancy with the levonorgestrel 52 mg IUD is 3 times lower than with optimal combined oral contraceptive use.

Hormone-related side effects in new users of a levonorgestrel 52-mg intrauterine device.

Background: Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects.

Objective: Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment.

Study Design: A total of 1714 women aged 16 to 45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years.

Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia.

Purpose: To describe the effects of estetrol (E4) 15 mgdrospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms.

Materials And Methods: We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 - 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ--scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain.

Menstrual cup use and intrauterine device expulsion in a copper intrauterine device randomized trial.

Objective: To evaluate menstrual cup use and intrauterine device (IUD) expulsion.

Study Design: We performed a secondary analysis of a 3-year contraceptive efficacy trial comparing two copper 380 mm IUDs. Investigators randomized participants approximately 1:4 to the TCu380A or NTCu380-Mini IUD.

Understanding the mechanical behavior of intrauterine devices during simulated removal.

Objective: To evaluate differences based on intrauterine device (IUD) frame geometry in force, and stress, and strain at the stem/arms junction during simulated IUD removal.

Study Design: We manufactured injection-molded frame models for three Nova-T IUDs (Mirena [model M]; Liletta [model L]; Kyleena [model K]) and a Tatum-T IUD (Paragard [model P]) at two-times scaling. We created a custom fixture to simulate the uterus and used a screw-driven machine to pull models at various displacement rates through the 10 cm fixture cavity to measure force and strain and calculate stress at the IUD stem/arms junction.

The benefits of estetrol addition to drospirenone for contraception.

Ethinylestradiol and drospirenone combined oral contraceptive formulations have been marketed for >20 years. Drospirenone has antimineralocorticoid and anti-androgenic effects that may offer several health benefits. Recently, 2 new drospirenone-containing oral contraceptives entered the market, 1 as a progestin-only pill containing 4 mg drospirenone and the other as a combined oral contraceptive containing 15 mg estetrol and 3 mg drospirenone.

The efficacy, safety, and tolerability of an estrogen-free oral contraceptive drospirenone 4 mg (24/4-day regimen) in obese users.

Objectives: This study aimed to compare contraceptive efficacy and safety of drospirenone 4 mg in a 24/4-day regimen in nonobese and obese users and describe pharmacokinetics according to bodyweight.

Study Design: We analyzed data from three drospirenone 4 mg trials (2 European and 1 United States) to report outcomes in nonobese (body mass index <30 kg/m) and obese (body mass index ≥30 kg/m) users. We used data from the US trial to calculate the Pearl Index (pregnancies per 100 woman-years) in nonbreastfeeding participants aged ≤35 years at enrollment for confirmed pregnancies.

Early pregnancy loss medical management in clinical practice.

Objectives: This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting.

Study Design: In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week.

Combined Oral Contraceptive Adherence and Pregnancy Rates.

Objective: To assess the relationship of adherence and pregnancy in participants using an estetrol and drospirenone combined oral contraceptive.

Methods: We performed a secondary analysis for which we pooled data from two parallel, multicenter, phase 3 trials (United States and Canada, Europe and Russia) that enrolled participants 16-50 years of age to receive estetrol 15 mg and drospirenone 3 mg in a 24 hormone and four placebo pills regimen for up to 13 cycles. Participants reported pill intake, sexual intercourse, and other contraceptive use on paper diaries.

Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device.

Objective: To evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions.

Methods: Investigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S.

Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use.

Funding Source: Medicines360. The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants.

Clinical Trial Registration: ClinicalTrials.

Management of cesarean scar ectopic pregnancies at an academic referral center: A case series.

Objectives: To describe treatment and outcomes of patients with confirmed cesarean scar ectopic pregnancy (CSEP) at a tertiary referral center.

Study Design: We reviewed a deidentified family planning clinical database for patients seen by our subspecialty service for CSEP from January 2017 through December 2021 in this case series. We extracted referral information, final diagnosis, management, and outcome measures including estimated blood loss, secondary procedures, and treatment complications.

Complex Family Planning fellowship graduates' intended practice plans and barriers to practicing in areas of unmet need.

Objectives: To describe practice patterns and challenges encountered by Complex Family Planning (CFP) fellowship graduates.

Study Design: We invited all 110 obstetrics and gynecology physicians who graduated from the CFP fellowship from 2017-2020 via email to complete an anonymous online survey. We inquired about demographics, intended and obtained postfellowship positions, and successes and challenges in obtaining jobs.