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  1. Article ; Online: Oestrogens in oral contraception: considerations for tailoring prescription to women's needs.

    Fruzzetti, Franca / Fidecicchi, Tiziana / Gambacciani, Marco

    The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception

    2024  , Page(s) 1–10

    Abstract: Background: The oestrogenic component of combined oral contraceptives (COCs) has changed over years with the aim of reducing oestrogen-related side effects and risks, whilst maintaining oestrogen beneficial effects, particularly on cycle control.: ... ...

    Abstract Background: The oestrogenic component of combined oral contraceptives (COCs) has changed over years with the aim of reducing oestrogen-related side effects and risks, whilst maintaining oestrogen beneficial effects, particularly on cycle control.
    Purpose: To describe the pharmacological profiles of different oestrogens commonly used in COCs to provide insights on contraceptive prescription tailored to women's needs.
    Results: All COCs ensure a high contraceptive efficacy. COCs containing the natural oestrogens oestradiol (E2), oestradiol valerate (E2V) and estetrol (E4) have limited impact on liver metabolism, lipid and carbohydrate metabolism, haemostasis and sex hormone binding globulin levels, compared with ethinylestradiol (EE). COCs with E2 and E2V appear also to entail a lower elevation of the risk of venous thromboembolism vs. EE-containing pills. No epidemiological data are available for E4-COC. E2- and E2V-containing COCs seem to exert a less stabilising oestrogenic effect on the endometrium compared with EE-COCs. The E4-COC results in a predictable bleeding pattern with a high rate of scheduled bleeding and minimal unscheduled bleeding per cycle. Based on
    Conclusion: Today various COCs contain different oestrogens. Prescribers must be familiar with the different properties of each oestrogen for a tailored contraceptive recommendation, considering their safety and contraceptive efficacy, as well as women's needs and preferences.
    Language English
    Publishing date 2024-04-29
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1397560-2
    ISSN 1473-0782 ; 1362-5187
    ISSN (online) 1473-0782
    ISSN 1362-5187
    DOI 10.1080/13625187.2024.2334350
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    Zs.A 4819: Show issues Location:
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  2. Article ; Online: Body mass index is a good predictor of metabolic abnormalities in polycystic ovary syndrome.

    Fruzzetti, F / Fidecicchi, T / Benelli, E / Baldari, F / Tonacchera, M

    Journal of endocrinological investigation

    2023  Volume 47, Issue 4, Page(s) 927–936

    Abstract: Aim: To assess which parameters among hyperandrogenism (total testosterone-tT-or free androgen index-FAI), sex hormone binding globulin (SHBG) or body mass index (BMI) could better predict a worse metabolic profile in women with polycystic ovary ... ...

    Abstract Aim: To assess which parameters among hyperandrogenism (total testosterone-tT-or free androgen index-FAI), sex hormone binding globulin (SHBG) or body mass index (BMI) could better predict a worse metabolic profile in women with polycystic ovary syndrome (PCOS).
    Methods: Five hundred and eighty-six women with PCOS and clinical or biochemical hyperandrogenism were included. Receiver Operating Characteristics (ROC) curves with tT, FAI, SHBG and BMI were performed for metabolic parameters and a cut-off with sensitivity and specificity was obtained for each parameter. The women were then divided into three groups and compared according to their BMI.
    Results: Based on the ROC curves, tT proved not to be a good predictor of metabolic alterations. FAI and SHBG resulted to be good predictors of some markers of metabolic damage. The area under the curves (AUC) of SHBG were greater than those of FAI. SHBG levels affects the values of homeostasis model assessment of insulin resistance (HOMA-IR), fasting insulin, high density lipoproteins (HDL), low density lipoproteins (LDL), and total cholesterol also when corrected for BMI. However, the highest AUCs of the ROC curves were observed when BMI was used, which was significantly related to all the metabolic parameters analyzed. Dividing women according to their BMI, BMI between 25.00 and 30.00 kg/m
    Discussion: BMI is a good predictor factor of metabolic changes in PCOS women at any age, and obesity is associated to the appearance of metabolic complications. Overweight and obese PCOS women should be addressed to perform a complete metabolic assessment.
    MeSH term(s) Female ; Humans ; Polycystic Ovary Syndrome/complications ; Hyperandrogenism/complications ; Body Mass Index ; Insulin/metabolism ; Testosterone ; Insulin Resistance ; Obesity/metabolism
    Chemical Substances Insulin ; Testosterone (3XMK78S47O)
    Language English
    Publishing date 2023-10-31
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 432272-1
    ISSN 1720-8386 ; 0391-4097 ; 1121-1369
    ISSN (online) 1720-8386
    ISSN 0391-4097 ; 1121-1369
    DOI 10.1007/s40618-023-02210-4
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  3. Article ; Online: Is the multinational, surveillance PRO-E2 study informative for all countries? The Italian data on VTE and contraceptive effectiveness.

    Fruzzetti, Franca / Cagnacci, Angelo / Boolell, Mitra / Di Carlo, Costantino / Bruni, Vincenzina

    The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception

    2024  Volume 29, Issue 1, Page(s) 1–7

    Abstract: Purpose: To evaluate whether the thromboembolic risk and contraceptive effectiveness of NOMAC-E2 observed in the PRO-E2 study can be extended to each participating country, as lifestyle, cardiovascular risk factors and prescribing habits may differ ... ...

    Abstract Purpose: To evaluate whether the thromboembolic risk and contraceptive effectiveness of NOMAC-E2 observed in the PRO-E2 study can be extended to each participating country, as lifestyle, cardiovascular risk factors and prescribing habits may differ geographically. This analysis was performed on the PRO-E2 Italian subpopulation, where smoking habit and women over 35 years were more prevalent compared with the overall study population.
    Materials and methods: Data from NOMAC-E2 or levonorgestrel-containing COCs (COC
    Results: Overall, 11,179 NOMAC-E2 and 8,504 COC
    Conclusion: Despite the higher age and tobacco use, findings from the Italian subpopulation were broadly consistent with overall PRO-E2 results, confirming a similar low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 and COC
    Short condensation: This subgroup analysis of the PRO-E2 study provides comprehensive epidemiological data on the use of combined oral contraceptives in a large Italian cohort, with a higher prevalence of women over 35 years and smokers. The study confirms the low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 pill.
    MeSH term(s) Pregnancy ; Female ; Humans ; Male ; Ethinyl Estradiol/adverse effects ; Estradiol/adverse effects ; Megestrol/adverse effects ; Contraceptive Effectiveness ; Venous Thromboembolism/chemically induced ; Venous Thromboembolism/epidemiology ; Contraceptives, Oral, Combined/adverse effects ; Italy/epidemiology
    Chemical Substances Ethinyl Estradiol (423D2T571U) ; Estradiol (4TI98Z838E) ; Megestrol (EA6LD1M70M) ; Contraceptives, Oral, Combined
    Language English
    Publishing date 2024-02-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 1397560-2
    ISSN 1473-0782 ; 1362-5187
    ISSN (online) 1473-0782
    ISSN 1362-5187
    DOI 10.1080/13625187.2023.2284085
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  4. Article ; Online: A review of the pharmacology, clinical outcomes, and real-world effectiveness, safety, and non-contraceptive effects of NOMAC/E2.

    Fruzzetti, Franca / Machado, Rogerio Bonassi / Lete, Iñaki / Patel, Amisha / Boolell, Mitra

    European journal of obstetrics & gynecology and reproductive biology: X

    2024  Volume 21, Page(s) 100283

    Abstract: Selecting an appropriate oral contraceptive can be challenging for healthcare professionals due to the abundance of marketed contraceptive options with different clinical and real-world effectiveness and safety profiles. Nomegestrol acetate + 17β- ... ...

    Abstract Selecting an appropriate oral contraceptive can be challenging for healthcare professionals due to the abundance of marketed contraceptive options with different clinical and real-world effectiveness and safety profiles. Nomegestrol acetate + 17β-estradiol (NOMAC/E2) is a combined oral contraceptive (COC) that inhibits ovulation by suppressing ovarian function by a 17-hydroxy-progesterone derivative and an estrogen identical to that endogenously produced by the ovaries. This narrative review examines clinical and real-world studies of NOMAC/E2 based on a background literature search using PubMed and Google Scholar. The review outlines the pharmacology of NOMAC/E2, including its progestational activity, pharmacokinetics, and effects on carbohydrate metabolism, lipid metabolism, and coagulation parameters, and summarizes key clinical efficacy and safety data that led to the approval of NOMAC/E2 in Europe, Brazil, and Australia. To help elucidate how NOMAC/E2 clinical trial data translate into a real-world setting, this review describes the effectiveness and safety of NOMAC/E2 in prospective studies that include over 90,000 users (half of whom received NOMAC/E2), outlining its effects on risk of thrombosis, menstrual bleeding patterns, weight, mood, acne, bone health, and patient quality of life. Non-contraceptive benefits of NOMAC/E2 for women with endometriosis, dysmenorrhea, or pre-menstrual dysphoric disorder are also discussed. These data demonstrate that NOMAC/E2 has a long half-life and rapid absorption, is effective at preventing unwanted pregnancies, and exhibits a favorable safety profile in both clinical trials and real-world settings. Importantly, NOMAC/E2 is not associated with increased risk of venous thromboembolism, a major safety concern of healthcare professionals for women receiving hormonal contraceptives. This review highlights NOMAC/E2 as a differentiated option among COCs and could help inform oral contraceptive choice to ultimately improve patient management and outcomes in real-world settings.
    Language English
    Publishing date 2024-01-22
    Publishing country Netherlands
    Document type Journal Article ; Review
    ISSN 2590-1613
    ISSN (online) 2590-1613
    DOI 10.1016/j.eurox.2024.100283
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  5. Article ; Online: How often is oral contraception used for contraception? The need of benefit's formalisation.

    Cagnacci, Angelo / Bruni, Vincenzina / Di Carlo, Costantino / Fruzzetti, Franca

    The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception

    2023  Volume 28, Issue 2, Page(s) 81–82

    MeSH term(s) Humans ; Contraception ; Contraceptives, Oral
    Chemical Substances Contraceptives, Oral
    Language English
    Publishing date 2023-02-10
    Publishing country England
    Document type Editorial
    ZDB-ID 1397560-2
    ISSN 1473-0782 ; 1362-5187
    ISSN (online) 1473-0782
    ISSN 1362-5187
    DOI 10.1080/13625187.2023.2170711
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  6. Article ; Online: The use of combined hormonal contraceptives amid the COVID-19 pandemic. Reply.

    Cagnacci, Angelo / Fruzzetti, Franca

    The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception

    2020  Volume 26, Issue 1, Page(s) 87–88

    MeSH term(s) COVID-19 ; Contraceptive Agents ; Humans ; Pandemics ; SARS-CoV-2
    Chemical Substances Contraceptive Agents
    Language English
    Publishing date 2020-11-27
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 1397560-2
    ISSN 1473-0782 ; 1362-5187
    ISSN (online) 1473-0782
    ISSN 1362-5187
    DOI 10.1080/13625187.2020.1850678
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  7. Article ; Online: Hormonal Contraception and Depression: Updated Evidence and Implications in Clinical Practice.

    Fruzzetti, Franca / Fidecicchi, Tiziana

    Clinical drug investigation

    2020  Volume 40, Issue 12, Page(s) 1097–1106

    Abstract: Hormonal contraceptives are used worldwide by more than 100 million women. Some studies have been published about the possible appearance of depressive symptoms when using hormonal contraceptives, but this link is still a matter of debate. The purpose of ...

    Abstract Hormonal contraceptives are used worldwide by more than 100 million women. Some studies have been published about the possible appearance of depressive symptoms when using hormonal contraceptives, but this link is still a matter of debate. The purpose of this review is to provide an update of the literature on this issue, and to investigate the possible explanations of this problem based on animal and human studies. The main pathway responsible for menstrual cycle-related mood changes is the γ-aminobutyric acid pathway, which is sensitive to changes in the levels of progesterone and of its metabolites, the neurosteroids. In particular, allopregnanolone is a potentiating neurosteroid with anxiolytic and anti-convulsant effects whose levels change during a normal menstrual cycle together with progesterone levels. Progestins have different effects on allopregnanolone, mainly owing to their diverse androgenicity. Moreover, they might affect brain structure and function, even though the meaning of these changes has yet to be clarified. It is important to define the groups of women in which negative mood disorders are more likely to occur. Adolescence is a critical period and this age-specific vulnerability is complex and likely bidirectional. Moreover, women with a history of mood affective disorders or premenstrual dysphoric syndrome are at a higher risk when taking contraceptives. In this review, we aim to provide clinicians with advice on how to approach these difficult situations.
    MeSH term(s) Adolescent ; Animals ; Depression/physiopathology ; Female ; Hormonal Contraception ; Humans ; Menstrual Cycle ; Pregnanolone/metabolism ; Premenstrual Dysphoric Disorder/physiopathology ; Premenstrual Syndrome/physiopathology ; Progesterone/metabolism ; Young Adult
    Chemical Substances Progesterone (4G7DS2Q64Y) ; Pregnanolone (BXO86P3XXW)
    Language English
    Publishing date 2020-09-27
    Publishing country New Zealand
    Document type Journal Article ; Review
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 0114-2402 ; 1173-2563
    ISSN (online) 1179-1918
    ISSN 0114-2402 ; 1173-2563
    DOI 10.1007/s40261-020-00966-8
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    Zs.A 2807: Show issues Location:
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  8. Article ; Online: Beyaz®: an oral contraceptive fortified with folate.

    Fruzzetti, Franca

    Women's health (London, England)

    2012  Volume 8, Issue 1, Page(s) 13–19

    Abstract: Beyaz(®) (Bayer HealthCare Pharmaceuticals, Berlin, Germany) consists of 28 film-coated tablets: 24 tablets each containing 3 mg drospirenone plus 20 µg ethinylestradiol (EE) and 451 µg levomefolate calcium followed by four tablets, each containing 451 ... ...

    Abstract Beyaz(®) (Bayer HealthCare Pharmaceuticals, Berlin, Germany) consists of 28 film-coated tablets: 24 tablets each containing 3 mg drospirenone plus 20 µg ethinylestradiol (EE) and 451 µg levomefolate calcium followed by four tablets, each containing 451 µg levomefolate calcium. It has the same indications of the parent compound 20 µg EE/3 mg drospirenone in a 24/4-day regimen (i.e., contraception, moderate acne, premenstrual dysforic disorder). In addition, the 24-day regimen with 20 µg EE/3 mg drospirenone/levomefolate calcium assure significant increases in red blood cell and plasma folate levels reaching values indicated to be protective in reducing the risk of neural tube defects. A progressive decrease in folate levels has been observed in women taking a 30 µg EE pill fortified with the same dose of levomefolate calcium upon discontinuation. At 4 and 8 weeks following cessation of the oral contraceptive, red blood cell folate levels >906 nmol/l were measured in 85 and 60% of women respectively. Because of this, the folate-containing pill may aid in reducing the risk of neural tube defects in a pregnancy conceived during use or shortly after the discontinuation of the product.
    MeSH term(s) Androstenes/administration & dosage ; Calcium/administration & dosage ; Contraception/methods ; Contraceptives, Oral, Combined/administration & dosage ; Drug Administration Schedule ; Ethinyl Estradiol/administration & dosage ; Evidence-Based Medicine ; Female ; Glutamates/administration & dosage ; Humans ; Neural Tube Defects/prevention & control ; Patient Satisfaction ; Tetrahydrofolates/administration & dosage
    Chemical Substances Androstenes ; Contraceptives, Oral, Combined ; Glutamates ; Tetrahydrofolates ; beyaz ; drospirenone and ethinyl estradiol combination ; Ethinyl Estradiol (423D2T571U) ; levomefolate calcium (A9R10K3F2F) ; Calcium (SY7Q814VUP)
    Language English
    Publishing date 2012-01
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2274503-8
    ISSN 1745-5065 ; 1745-5057
    ISSN (online) 1745-5065
    ISSN 1745-5057
    DOI 10.2217/whe.11.68
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    Zs.A 6629: Show issues Location:
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  9. Article ; Online: Venous thrombosis and hormonal contraception: what's new with estradiol-based hormonal contraceptives?

    Fruzzetti, Franca / Cagnacci, Angelo

    Open access journal of contraception

    2018  Volume 9, Page(s) 75–79

    Abstract: Objective: Estradiol (E2)-based hormonal contraceptives impact less than ethinylstradiol (EE) contraceptives on venous thromboembolism (VTE) in comparison to formulations with EE.: Study design: In this article, the pharamacologic data of EE and E2 ... ...

    Abstract Objective: Estradiol (E2)-based hormonal contraceptives impact less than ethinylstradiol (EE) contraceptives on venous thromboembolism (VTE) in comparison to formulations with EE.
    Study design: In this article, the pharamacologic data of EE and E2 were briefly reviewed, along with the induced biologic effect. These data were then related to a recent large international prospective, controlled, non-interventional cohort active surveillance study, on the cardiovascular risk of users of different types of combined estroprogestin contraceptive (CEPC).
    Results: The crude HR for E2-valerate (E2V)/dienogest vs other CEPCs with EE was 0.8 (95% CI, 0.4-1.6), but when the data were corrected for age, body mass index, duration of use, and family history of VTE, the corresponding adjusted HR was 0.5 (95% CI, 0.2-1.0). A comparison of the E2V/dienogest and EE/levonorgestrel groups showed that the two contraceptives induced a similar VTE risk with the crude and adjusted VTE HRs of 0.7 (95% CI, 0.3-1.8) and 0.5 (95% CI, 0.2-1.3), respectively. Similar results were obtained when the observation was prolonged to January 2017.
    Conclusions: The reduced impact of E2 vs EE on coagulation translates into the epidemiologic evidence of a reduced number of events in E2V vs EE users, when progestins other than levonorgestrel are used. However, E2 may continue to negatively impact on the risk of VTE, and this should not be forgotten at the time of prescription. Family history of VTE or thrombophilia, age, and obesity are risk factors for VTE too. If these risk factors are not taken into consideration and excluded, they can overcome or hide the higher safety of E2 vs CEPCs with EE.
    Language English
    Publishing date 2018-11-08
    Publishing country New Zealand
    Document type Editorial
    ZDB-ID 2586656-4
    ISSN 1179-1527 ; 1179-1527
    ISSN (online) 1179-1527
    ISSN 1179-1527
    DOI 10.2147/OAJC.S179673
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  10. Article ; Online: Comparison of PCOS phenotypes in adolescent and young adult Mediterranean women with possible PCOS.

    Fruzzetti, F / Baldari, F / Palla, G / Fidecicchi, T / Carmina, E

    Journal of endocrinological investigation

    2020  Volume 44, Issue 5, Page(s) 995–1000

    Abstract: Purpose: During adolescence, PCOS features are supposed to be in evolution. Because of this, the diagnosis of PCOS in adolescence is often unclear and few studies have compared adolescent and adult PCOS phenotype distribution and features. The aim is to ...

    Abstract Purpose: During adolescence, PCOS features are supposed to be in evolution. Because of this, the diagnosis of PCOS in adolescence is often unclear and few studies have compared adolescent and adult PCOS phenotype distribution and features. The aim is to compare phenotypes in adolescents and young adults with PCOS.
    Methods: 109 girls aged from 13 to 19 years were retrospectively studied. All patients had a gynecological age > 2 years. 63 patients were adolescents (3-5 years beyond menarche) while 46 patients were young adults (6-9 years beyond menarche). Diagnosis of different PCOS phenotypes (A, B, C, D) was made according to the Rotterdam criteria. Clinical data (menstrual cycles, BMI, presence of hirsutism), androgen circulating levels (total testosterone, androstenedione, dehydroepiandrosterone sulphate) and ovarian morphology by ultrasound were assessed.
    Results: 109 patients presented PCOS according to the Rotterdam criteria. Phenotype A was by far the most common phenotype (73.4%) followed by phenotype B (21.1%). Only few patients had phenotype C (4.6%) or phenotype D (0.9%). When patients were divided in two groups (adolescent and young adult patients), no significant difference in prevalence and features of the different phenotypes was observed.
    Conclusion: In this cohort of adolescent and young adult women with PCOS, the progression of age does not change the prevalence and the features of main PCOS phenotypes. It suggests that the Rotterdam criteria might be used also in adolescents, at least in those with 2 or more years of gynecological age, for the diagnosis of PCOS.
    MeSH term(s) Adolescent ; Androgens/blood ; Body Mass Index ; Early Diagnosis ; Female ; Hirsutism/diagnosis ; Hirsutism/metabolism ; Humans ; Italy/epidemiology ; Menarche/metabolism ; Ovary/diagnostic imaging ; Phenotype ; Polycystic Ovary Syndrome/diagnosis ; Polycystic Ovary Syndrome/epidemiology ; Polycystic Ovary Syndrome/metabolism ; Polycystic Ovary Syndrome/physiopathology ; Prevalence ; Ultrasonography/methods ; Young Adult
    Chemical Substances Androgens
    Keywords covid19
    Language English
    Publishing date 2020-08-24
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 432272-1
    ISSN 1720-8386 ; 0391-4097 ; 1121-1369
    ISSN (online) 1720-8386
    ISSN 0391-4097 ; 1121-1369
    DOI 10.1007/s40618-020-01394-3
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