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.

Ethnicity and the Prevalence of Polycystic Ovary Syndrome: The Eastern Siberia PCOS Epidemiology and Phenotype Study.

Context: Previous studies have shown that the prevalence of polycystic ovary syndrome (PCOS) may vary according to race/ethnicity, although a few studies have assessed women of different ethnicities who live in similar geographic and socioeconomic conditions.

Objective: To determine the prevalence of PCOS in an unselected multiethnic population of premenopausal women.

Design: A multicenter prospective cross-sectional study.

Ovarian Morphology in Non-Hirsute, Normo-Androgenic, Eumenorrheic Premenopausal Women from a Multi-Ethnic Unselected Siberian Population.

Polycystic ovary syndrome (PCOS) is a highly prevalent disorder in women, and its diagnosis rests on three principal features: ovulatory/menstrual dysfunction, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology (PCOM). Currently, data on age- and ethnicity-dependent features of PCOM remain insufficient. We aimed to estimate ethnicity- and age-dependent differences in ovarian volume (OV) and follicle number per ovary (FNPO) in a healthy, medically unbiased population of Caucasian and Asian premenopausal women, who participated in the cross-sectional Eastern Siberia PCOS epidemiology and phenotype (ESPEP) study (ClinicalTrials.

Polycystic Ovary Syndrome and Gut Microbiota: Phenotype Matters.

Abnormalities in gut microbiota diversity are considered important mechanisms in metabolic disorders in polycystic ovarian syndrome (PCOS). However, the data on the association of these disorders with the PCOS phenotype remain controversial. The objectives of this study were to estimate the alpha diversity of the gut microbiota of healthy women and PCOS patients depending on phenotype.

Establishing Normative Values to Determine the Prevalence of Biochemical Hyperandrogenism in Premenopausal Women of Different Ethnicities from Eastern Siberia.

Androgen assessment is a key element for diagnosing polycystic ovary syndrome (PCOS), and defining a "normal" level of circulating androgens is critical for epidemiological studies. We determined the upper normal limits (UNLs) for androgens in a population-based group of premenopausal "healthy control" women, overall and by ethnicity (Caucasian and Asian), in the cross-sectional Eastern Siberia PCOS Epidemiology and Phenotype (ESPEP) Study (ClinicalTrials.gov ID: NCT05194384) conducted in 2016-2019.

Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials.

Objectives: To evaluate tolerability and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg oral contraceptive using pooled data from two, multicenter, phase 3 trials.

Study Design: The two trials enrolled participants aged 16-50 years with a body mass index ≤35.0 kg/m to use E4/DRSP in a 24/4-day regimen for up to 13 cycles.

Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women.

Objective: To evaluate the bleeding patterns of a new combined oral contraceptive containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg in a 24/4-day regimen.

Study Design: We pooled bleeding data from two parallel, open-label, 13-cycle phase 3 trials that enrolled participants 16 to 50 years old with body mass index (BMI) ≤35 kg/m. Participants reported vaginal bleeding/spotting in daily diaries.

Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials.

Objective: To evaluate overall and subgroup efficacy of an estetrol (E4) 15 mg drospirenone (DRSP) 3 mg oral contraceptive in a 24/4-day regimen.

Study Design: We pooled efficacy outcomes from 2 pivotal phase 3 contraceptive trials with E4/DRSP conducted in the United States/Canada and Europe/Russia. We assessed Pearl Index (PI; pregnancies per 100 participant-years) and 13-cycle life-table pregnancy rates in at-risk cycles (confirmed intercourse and no other contraceptive use) among participants 16 to 35 years.

The Leydig Steroid Cell Tumor in a Postmenopausal Woman with Clinical and Biochemical Hyperandrogenism: A Case Report.

Leydig cell tumors (LCTs) refer to tumors of the stroma of the genital strand, which are found mainly in postmenopausal women. The diagnosis of LCTs in postmenopausal women is associated with specific difficulties and is based on the identification of hyperandrogenism with clinical manifestations of virilization, which has an erased picture in postmenopausal women. LCTs require differential diagnosis with other causes of hyperandrogenism.

PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data.

The diagnosis of polycystic ovary syndrome (PCOS) remains challenging due to limited data regarding normative cut-offs for the diagnostic features in different subpopulations. We aim to conduct a systematic review, build a comprehensive repository of de-identified individual participant data (IPD), and define normative ranges and diagnostic cut-offs for all PCOS diagnostic features. We will conduct a systematic search of MEDLINE and EMBASE databases for studies that assessed PCOS diagnostic features in unselected women.

Comparison of two levonorgestrel-releasing intrauterine systems for the treatment of heavy menstrual bleeding: a randomised, controlled, phase 3 trial.

Purpose: To evaluate the levonorgestrel-releasing intrauterine system Donasert (also known as Levosert) compared with the reference product Mirena for the alleviation of heavy menstrual bleeding (HMB).

Materials And Methods: A phase 3 multicentre, non-inferiority, active-controlled study in non-menopausal women with HMB (menstrual blood loss [MBL] ≥ 80 mL) as the primary symptom randomised to either Donasert or Mirena and followed for 6 months. MBL was evaluated using a validated, modified version of the Wyatt pictogram.

Metagenome datasets from women with polycystic ovary syndrome from Irkutsk, Eastern Siberia, Russia.

For the metagenomic characterization of potential taxonomic and functional diversity of microorganisms associated with polycystic ovary syndrome (PCOS) in women, we surveyed five women with PCOS and collected samples of feces, saliva, and serum. After quality processing, we have obtained from 915,594 to 3,880,379 reads; these 16,693 sequences had ribosomal RNA genes, 2,091,990 sequences contained predicted proteins with known functions, and 3,750,261 sequences had predicted proteins with unknown functions. Host DNA accounted for ca.

Criteria, phenotypes and prevalence of polycystic ovary syndrome.

Polycystic ovarian syndrome (PCOS) is known as one of the most frequent endocrine diseases in women worldwide. However, this term does not completely capture the diversity of clinical signs associated with this syndrome e.g.

Is polycystic ovary syndrome a 20th Century phenomenon?

Polycystic ovary syndrome (PCOS) affects around 10% of women of reproductive age and is most common in developed countries. The aetiology of PCOS is not completely understood. Current evidence suggests that the syndrome results from a genetic predisposition interacting with developmental events during fetal or perinatal life that together increase susceptibility in some individuals.

Minimal difference in phenotype between adolescents and young adults with polycystic ovary syndrome.

Objective: To test the hypothesis that the polycystic ovary syndrome (PCOS) phenotype, or its component features, is less severe in adolescents than in young adult patients, in a referred (clinical) population.

Design: Cross-sectional study.

Setting: Tertiary-care academic medical center.

Efficacy and Safety of Estradiol Valerate/Dienogest for the Management of Heavy Menstrual Bleeding: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Clinical Trial.

Background: To investigate the efficacy and safety of estradiol valerate (EV)/dienogest (DNG) for the management of heavy menstrual bleeding (HMB) in Asian and non-Asian women desiring contraception.

Materials And Methods: In this multicenter, double-blind, phase III study, women were randomized 2:1 to receive EV/DNG or placebo tablets daily for seven 28-day cycles. The primary endpoint was the absolute change in menstrual blood loss (MBL) volume between the run-in and efficacy phases (90 days each).

Genetics of polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is a hormonal and metabolic disorder affecting 5 to 20% of reproductive-aged women worldwide that results in androgen excess, menstrual dysfunction and oligo-ovulatory subfertility, with increased risks for type 2 diabetes, endometrial adenocarcinoma, and potentially vascular disease, among other morbidities. PCOS is a complex genetic trait with strong heritability accounting for as high as 70% of the development of the disorder. Areas covered: The authors summarize the historical and recent findings of genetic studies of PCOS, such as familial studies, twin studies, and molecular genetic studies, including the results of recent genome wide associated studies.

Genetic basis of eugonadal and hypogonadal female reproductive disorders.

This review discusses the current state of our understanding regarding the genetic basis of the most important reproductive disorders in women. For clarity, these disorders have been divided into eugonadal and hypogonadal types. Hypogonadal disorders have been further subdivided according to serum gonadotropin levels.

Phenotypes and body mass in women with polycystic ovary syndrome identified in referral versus unselected populations: systematic review and meta-analysis.

Objective: To compare the prevalence of polycystic ovary syndrome (PCOS) phenotypes and obesity among patients detected in referral versus unselected populations.

Design: Systematic review and meta-analysis.

Setting: Not applicable.

Criteria, prevalence, and phenotypes of polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is a highly prevalent disorder effecting reproductive-aged women worldwide. This article addresses the evolution of the criteria used to diagnosis PCOS; reviews recent advances in the phenotypic approach, specifically in the context of the extended Rotterdam criteria; discusses limitations of the current criteria used to diagnosis, particularly when studying adolescents and women in the peri- and postmenopause; and describes significant strides made in understanding the epidemiology of PCOS. This review recognizes that although there is a high prevalence of PCOS, there is increased variability when using Rotterdam 2003 criteria, owing to limitations in population sampling and approaches used to define PCOS phenotypes.

Lipid peroxidation and antioxidant protection in girls with type 1 diabetes mellitus during reproductive system development.

Background And Objective: Type 1 diabetes mellitus (T1D) is found worldwide and is regarded as one of the main risks to human health. The objective of this study was to determine the state of lipid peroxidation (LPO) and antioxidant protection in girls with T1D type considering the stages of reproductive system development.

Materials And Methods: This study enrolled 56 young girls with T1D and 60 healthy girls (control) matched by age.

Antioxidant status in peri- and postmenopausal women.

Menopause is a risk factor for oxidative stress. The aim of our study is to assess antioxidant system parameters (α-tocopherol, retinol, reduced glutathione, total antioxidant activity) in peri- and postmenopausal women. The antioxidant defense activity by estimation of total antioxidant activity, α-tocopherol, retinol, oxidized and reduced glutathione levels was studied in women of reproductive age (n=37), in perimenopausal (n=41) and postmenopausal women (n=41).