The Burden of Pelvic Pain Associated With Endometriosis Among Women in Selected European Countries and the United States: A Restricted Systematic Review.

Objective: To evaluate the burden of endometriosis-associated pelvic pain (EAPP) on health-related quality of life (HRQoL) among women living in similar socio-economic conditions.

Data Sources: Searches were performed in PubMed and Embase on September 26, 2022. The review was performed in conformity with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P) and was registered on PROSPERO (ID: CRD42023370363).

Discontinuation rates of intrauterine contraception due to unfavourable bleeding: a systematic review.

Objective: Levonorgestrel-releasing intrauterine devices (LNG-IUDs) and copper intrauterine devices (Cu-IUDs) offer long-acting contraception; however, some women may discontinue use within the first year due to bleeding pattern changes, limiting their potential. This systematic literature review investigated whether differences in bleeding profiles influence continuation rates in women in America, Europe and Australia.

Methods: Searches performed in PubMed and Embase were screened to identify publications describing bleeding patterns and rates of early IUC removal/discontinuation or continuation, descriptions of bleeding patterns, reasons for discontinuation, and patient satisfaction, acceptability and tolerability for LNG-IUDs and Cu-IUDs published between January 2010 and December 2019.

Comparative pharmacokinetic analysis of levonorgestrel-releasing intrauterine systems and levonorgestrel-containing contraceptives with oral or subdermal administration route.

Objective: To compare systemic exposure to levonorgestrel (LNG) released from commercially available intrauterine systems (IUSs), a subdermal implant, and oral contraceptives.

Methods: An integrated population pharmacokinetic (popPK) analysis of data from over 3400 individuals in ten clinical studies with six different LNG-releasing contraceptives (four long-acting reversible contraceptives [LARCs: LNG-IUS 8, 12, and 20, initially releasing LNG 14, 17.5, and 20 μg/day, a subdermal implant initially releasing LNG 100 μg/day according to label]; progestin-only pill [POP: LNG 30 μg/day]; and combined oral contraceptive [COC] pill [LNG 100 μg/day and ethinylestradiol 20 μg/day]), was conducted to generate a popPK model.

Dienogest 2 mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis: The VISanne Study to Assess Safety in ADOlescents.

Study Objective: To study the safety and efficacy of dienogest 2 mg in adolescents with suspected endometriosis.

Design: A 52-week, open-label, single-arm study.

Setting: In 21 study centers, in 6 European countries.

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).

Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive.

Objective: To determine the relative bioavailability of ethinyl estradiol (EE) and gestodene (GSD) after application of a novel transdermal contraceptive patch vs. a standard combined oral contraceptive (COC) pill (study 1), and to evaluate the pharmacokinetics (PK) of EE after application of the EE/GSD patch compared with an EE/norelgestromin (NGMN) patch (study 2).

Materials: Participants were healthy, nonobese women aged 18 - 45 years (study 1) or 18 - 35 years (study 2).

Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter, open-label, uncontrolled study over three treatment cycles.

Background: Body mass index (BMI) may influence ovulation inhibition resulting from transdermal hormone delivery. Investigation of this effect is important given the high prevalence of obesity in the US.

Study Design: This open-label, uncontrolled, Phase 2b trial stratified 173 women (18-35 years) according to three BMI groups (Group 1, n = 56, ≤ 30 kg/m²; Group 2, n = 55, > 30 kg/m² and ≤ 35 kg/m²; and Group 3, n = 47, > 35 kg/m²).

Different Pearl Indices in studies of hormonal contraceptives in the United States: impact of study population.

Objective: To examine the impact of subject characteristics on efficacy as measured by the Pearl Index (PI) in clinical trials and to make study populations similar by matching.

Methods: Our analysis used US data from four large Phase III studies. We compared results from one fertility control patch study with pooled data from three studies with virtually identical design on oral hormonal contraceptives.

Effect of a low-dose contraceptive patch on efficacy, bleeding pattern, and safety: a 1-year, multicenter, open-label, uncontrolled study.

This Phase III, uncontrolled, open-label, multicenter study was conducted to investigate the contraceptive efficacy, bleeding pattern, and cycle control of a novel once-a-week contraceptive patch, delivering low-dose ethinyl estradiol (EE) and gestodene (GSD) at the same systemic exposure seen after oral administration of a combined oral contraceptive containing 0.02 mg EE/0.06 mg GSD.

Effects of an ethinyl estradiol/gestodene transdermal contraceptive patch on the endometrium: a single-center, uncontrolled study.

Aim: This study aims to investigate the effect of a transdermal contraceptive patch containing ethinyl estradiol and gestodene on endometrial proliferation over 1 year.

Materials & Methods: In this open-label, uncontrolled, Phase IIb study, women (aged 18-35 years) used the patch for 13 cycles of 28 days. The primary variable was histologic endometrial effects at cycle 13.

Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study.

Background: Transdermal delivery of contraceptives offers several advantages over combined oral contraceptives (COCs), including effective absorption and the provision of relatively constant serum concentrations. Ethinyl estradiol (EE) and the progestin gestodene are well-absorbed through the skin and, therefore, well-suited for use in a transdermal contraceptive patch.

Objective: The objective of this study was to investigate the impact of a once-weekly transparent, transdermal patch delivering low doses of EE and gestodene equivalent to a COC containing 0.