Low thrombin generation in postmenopausal women using estetrol.

Objective: Estetrol (E4) represents a novel estrogen of interest to relieve vasomotor symptoms. E4 activates the nuclear estrogen receptor α (ERα) but antagonizes the estradiol ERα-dependent membrane-initiated steroid signaling pathway. The distinct pharmacological properties of E4 could explain its low impact on hemostasis.

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.

A multicenter, randomized, placebo-controlled study to select the minimum effective dose of estetrol in postmenopausal participants (E4Relief): part 2-vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life.

Objective: A phase 2 study showed that 15 mg estetrol (E4) alleviates vasomotor symptoms (VMS). Here, we present the effects of E4 15 mg on vaginal cytology, genitourinary syndrome of menopause, and health-related quality of life.

Methods: In a double-blind, placebo-controlled study, postmenopausal participants (n = 257, 40-65 y) were randomized to receive E4 2.

Impact of estetrol (E4) on hemostasis, metabolism and bone turnover in postmenopausal women.

Objective: This study aimed to determine the effects of estetrol (E4) on hemostasis, lipids, carbohydrate metabolism and bone turnover in postmenopausal women.

Methods: This study was a multicenter, randomized, double-blind placebo-controlled phase 2 trial. Participants ( = 180, age 43-64 years) received E4 2.

Low Thrombin Generation in Users of a Contraceptive Containing Estetrol and Drospirenone.

Objective: To compare the impact on thrombin generation of the new combined oral contraceptive containing 15 mg estetrol and 3 mg drospirenone with ethinylestradiol (30 or 20 mcg) associated either with 150 mcg levonorgestrel or with 3 mg drospirenone.

Methods: Data were collected from the "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" (NCT02957630). Overall, the per-protocol set population included 24 subjects in the ethinylestradiol/levonorgestrel arm, 28 subjects in the ethinylestradiol/drospirenone arm, and 34 subjects in the estetrol/drospirenone arm.

Analytical performance of the endogenous thrombin potential-based activated protein C resistance assay on the automated ST Genesia system.

Background: The evaluation of activated protein C (APC) resistance based on the endogenous thrombin potential (ETP) is recommended during the development of steroid contraceptives in women. In 2019, this assay was validated on the calibrated automated thrombogram (CAT) device. However, in view of its screening potential, its automation is essential.

Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause.

Introduction: Estrogens used in women's healthcare have been associated with increased risks of venous thromboembolism (VTE) and breast cancer. Estetrol (E4), an estrogen produced by the human fetal liver, has recently been approved for the first time as a new estrogenic component of a novel combined oral contraceptive (E4/drospirenone [DRSP]) for over a decade. In phase 3 studies, E4/DRSP showed good contraceptive efficacy, a predictable bleeding pattern, and a favorable safety and tolerability profile.

Combined Oral Contraceptives and Venous Thromboembolism: Review and Perspective to Mitigate the Risk.

Many factors must be considered and discussed with women when initiating a contraceptive method and the risk of venous thromboembolism (VTE) is one of them. In this review, we discuss the numerous strategies that have been implemented to reduce the thrombotic risk associated with combined oral contraceptives (COCs) from their arrival on the market until today. Evidences suggesting that COCs were associated with an increased risk of VTE appeared rapidly after their marketing.

[«I am not pregnant !» About denial of pregnancy…].

The term «denial of pregnancy», although used in current medical practice since 1970, does not yet have a universal definition. The literature allows to define it as «the non-recognition of a pregnancy beyond the first trimester, which can last until delivery and cover it». The changes related to pregnancy are biologically reduced or incorrectly perceived or even ignored.

A multicenter, randomized study to select the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety.

Objective: The aim of this study was to select the minimum effective dose of estetrol (E4) for the treatment of vasomotor symptoms in postmenopausal women.

Methods: This was a multicenter, randomized, double-blind, placebo-controlled study. Postmenopausal women (n = 257, of whom 32 were hysterectomized) aged 40 to 65 years, with ≥7 moderate to severe hot flushes (HFs) per day, or 50 or more moderate to severe HFs weekly, received 2.

Oral investigational drugs currently in phase I or phase II for the amelioration of menopausal symptoms.

Introduction: Menopausal symptoms have a substantial effect on the quality of life of many women; hence, investigations for the amelioration of menopausal symptoms continue to be necessary. The two main approaches to the amelioration of symptoms are hormone therapy (HT) and non-hormonal therapy.

Areas Covered: This review provides a background for understanding the types of menopausal symptoms and their underlying physiology.

Exploring the interest in and the usage of the internet among patients eligible for osteoporosis screening.

The aim of this study was to evaluate the interest in the Internet and its usage for health-related issues among people eligible for osteoporosis screening. Self-administered questionnaires have been distributed to subjects who were screened for osteoporosis and to menopausal women. 177 patients have responded to the survey (64.

[The use of intrauterine device in nulliparous over 18 years: a Belgian consensus].

Under the presidency of prof. H. Depypere (UZ Ghent) and Prof.

Asymmetric facial skin viscoelasticity during climacteric aging.

Background: Climacteric skin aging affects certain biophysical characteristics of facial skin. The purpose of the present study was to assess the symmetric involvement of the cheeks in this stage of the aging process.

Methods: Skin viscoelasticity was compared on both cheeks in premenopausal and post-menopausal women with indoor occupational activities somewhat limiting the influence of chronic sun exposure.

Revisiting the cutaneous impact of oral hormone replacement therapy.

Menopause is a key point moment in the specific aging process of women. It represents a universal evolution in life. Its initiation is defined by a 12-month amenorrhea following the ultimate menstrual period.

[Zoely, a combined oral contraceptive, monophasic pill containing estradiol and nomegestrol acetate].

A new combined oral contraceptive called Zoely has just been marketed in Belgium. It contains nomegestrol acetate, a progestin known for its high contraceptive reliability based on its antigonadotropic power and long half-life. This progestin is associated with estradiol and Zoely is devoid of ethinyl estradiol, which is the usual component of the majority of combined oral contraceptives and is primarily responsible for thrombotic side effects of the pill.

[Breast cancer in Belgium: why are we the first in Europe?].

Breast cancer incidence in Belgium is on the top of European countries, with 9.697 new cases in 2008 and 106/100.000 women/year.

[Medication of the month. Femoston Low (0.5 mg estradiol plus 2.5 mg dydrogesterone) for menopausal hormonal replacement therapy].

Femoston Low is a hormone replacement therapy that combines low dosages of steroids, i.e. 0.

[Medication of the month. A new combined oral contraceptive containing estradiol valerate and dienogest (Qlaira)].

In combined oral contraception (OC), a drastic reduction of both ethinylestradiol and androgenic progestins mostly derived from 19 NOR testosterone, allowed to moderately reduce the adverse impact of classical combined pills on metabolism and circulation (both arterial and venous). However, the marked hepatic action of ethinylestradiol, even in small dosages, lessens the expected risk reduction. For the first time, an OC has been developed, which contains estradiol valerate (with reduced hepatic action because of lack of a 17alpha ethinyl group) with dienogest, a 19 NOR testosterone-derived nonandrogenic progestin, which powerfully inhibits endometrial proliferation.

[Ulipristal acetate: an emergency contraception extended to 5 days using a progesterone receptor modulator (Ellaone)].

Emergency contraception is a second chance for prevention of pregnancy after unprotected intercourse. Hormonal emergency contraception with levonorgestrel 1.5 mg, only provides an effective contraception from 0 to 72 hours after intercourse with decreasing effectiveness as time elapses.

Hyperinsulinaemia, a key factor of the metabolic syndrome in postmenopausal women.

The metabolic syndrome (MetS) is a complex disorder combining obesity, hypertension, atherogenic dyslipidaemia and insulin resistance, a clustering of factors which markedly enhance the risk of developing cardiovascular disease (CVD) and type 2 diabetes. Main features of the MetS, which are found in many postmenopausal women, are increasing prevalence of insulin resistance and obesity (particularly visceral adiposity). Accordingly, a majority of postmenopausal women comply with criteria defining the MetS, and CVD is the first cause of morbidity/mortality in women, occurring even more frequently than in men.