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Article ; Online: Phyto-progestins for the treatment of abnormal uterine bleeding without organic cause in women at high risk for breast cancer and breast cancer survivors: a prospective, pilot study.

Grandi, Giovanni / Facchinetti, Fabio / Melotti, Chiara / Sgandurra, Alice

Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology

2023 Volume 39, Issue 1, Page(s) 2239936

Abstract: Objectives: Some plants, such as Dioscorea Villosa (DV), Vitex Agnus Castus (VAC) and Turnera diffusa (D) have some 'progesterone-like' properties. We have investigated their simultaneous administration in breast cancer (BC) survivors or carriers of ... ...

Abstract	Objectives: Some plants, such as Dioscorea Villosa (DV), Vitex Agnus Castus (VAC) and Turnera diffusa (D) have some 'progesterone-like' properties. We have investigated their simultaneous administration in breast cancer (BC) survivors or carriers of specific genetic mutations that can increase the risk of developing BC suffering from abnormal uterine bleeding without organic cause. Methods: Women with irregular cycles in terms of length (interval between ≤ 24 or ≥ 38 days) without a uterine organic disease (polyps, adenomyosis, fibroids, hyperplasia/malignancy) were included. A daily diary of bleeding, questionnaires about health-related quality of life (Short Form 36) and menstrual psychophysical well-being (PGWB-1) and the Greene Climacteric Scale (GCS) (in women older than 40 years old) questionnaire were used. The presence of some premenstrual syndrome (PMS) symptoms was also evaluated. Results: In the analyzed group of women ( Conclusions: A combination of DV, VAC and D could be a promising candidate to treat menstrual irregularities without an organic cause, with a significant reduction of menstrual pain and flow intensity and possible additional benefits in PMS symptoms treatment in women at genetic risk for BC and BC survivors.
MeSH term(s)	Female ; Humans ; Adult ; Progestins ; Pilot Projects ; Breast Neoplasms/complications ; Cancer Survivors ; Prospective Studies ; Dysmenorrhea ; Quality of Life ; Premenstrual Syndrome/drug therapy ; Uterine Diseases ; Vitex ; Uterine Hemorrhage
Chemical Substances	Progestins
Language	English
Publishing date	2023-07-26
Publishing country	England
Document type	Journal Article
ZDB-ID	639237-4
ISSN	1473-0766 ; 0951-3590
ISSN (online)	1473-0766
ISSN	0951-3590
DOI	10.1080/09513590.2023.2239936
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Article ; Online: The role of combined oral contraceptives containing norgestimate for acne vulgaris treatment: a review.

Grandi, Giovanni / Guariglia, Gloria / Facchinetti, Fabio

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

2023 Volume 28, Issue 3, Page(s) 184–191

Abstract: Introduction: Both Food and Drugs Administration and European Medicine Agency (EMA) approve the use of a triphasic combined oral contraceptive (COC) containing ethinyl-oestradiol (EE) and norgestimate (NGM) for acne vulgaris treatment in women requiring ...

Abstract	Introduction: Both Food and Drugs Administration and European Medicine Agency (EMA) approve the use of a triphasic combined oral contraceptive (COC) containing ethinyl-oestradiol (EE) and norgestimate (NGM) for acne vulgaris treatment in women requiring an effective contraception. COCs can target sebum production and may also play a role in decreasing follicular hyperkeratinisation. Results: Specific advantages of the use of an anti-androgenic progestin such as NGM in this condition are presented in this review, including the lowest venous thrombosis risk in the COCs scenario, as established by the EMA, associated with a very satisfactory cycle control. The results of aggregate analysis of published data ( Conclusions: The choice of a triphasic combination of EE/NGM seems a referenced, highly effective, easy-to-use and safe therapeutic approach for acne vulgaris, alone or in combination with different targeted drugs.
MeSH term(s)	Female ; Humans ; Contraceptives, Oral, Combined/therapeutic use ; Norgestrel/therapeutic use ; Ethinyl Estradiol/therapeutic use ; Acne Vulgaris/drug therapy
Chemical Substances	Contraceptives, Oral, Combined ; norgestimate (C291HFX4DY) ; Norgestrel (3J8Q1747Z2) ; Ethinyl Estradiol (423D2T571U)
Language	English
Publishing date	2023-04-12
Publishing country	England
Document type	Review ; Journal Article
ZDB-ID	1397560-2
ISSN	1473-0782 ; 1362-5187
ISSN (online)	1473-0782
ISSN	1362-5187
DOI	10.1080/13625187.2023.2197539
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Article ; Online: L-Arginine supplementation in pregnancy: a systematic review of maternal and fetal outcomes.

Menichini, Daniela / Feliciello, Lia / Neri, Isabella / Facchinetti, Fabio

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

2023 Volume 36, Issue 1, Page(s) 2217465

Abstract: Background/aim of the study: L-Arginine (L-Arg)/Nitric Oxide (NO) system is involved in the pathophysiology of relevant Obstetric conditions. This review aims at summarizing the effects of L-Arg supplementation in pregnancy looking at safety and ... ...

Abstract	Background/aim of the study: L-Arginine (L-Arg)/Nitric Oxide (NO) system is involved in the pathophysiology of relevant Obstetric conditions. This review aims at summarizing the effects of L-Arg supplementation in pregnancy looking at safety and efficacy. Methods: We conducted a systematic review of the literature utilizing PubMed for studies published from inception to September 2022. The search included human and animal studies where L-Arg was supplemented pre-conceptionally or during pregnancy, by either oral or intravenous route. The main perinatal outcomes were focused. Results: Among 1028 publications, 51 studies were eligible for inclusion, 25 were performed in women, and the remnant in animals. Compared to controls/placebo, the supplementation with L-Arg reduced the development of pre-eclampsia (four studies), decreased blood pressure, and reduced the need for antihypertensive drugs in women with Hypertensive Disorders of Pregnancy (HDP, eight studies). In women carrying growth retarded fetuses, L-Arg improved fetoplacental circulation, birth weight and neonatal outcomes (five studies), while in the case of threatened preterm birth, L-Arg reduced uterine contractions (two studies). In several animal species, L-Arg supplementation in pregnancy improved reproductive performance by increasing the litter number and size. Moreover, in pre-eclamptic and metabolic syndrome experimental models, maternal hypertension and fetal growth were improved. Conclusion: L-Arg displays biological activities in pregnancies complicated by HDP and growth restriction, both in women and animal models. L-Arg administration is safe and could be a candidate as an intervention beneficial to maternal and fetal outcomes, at least in moderate clinical disorders.
MeSH term(s)	Pregnancy ; Animals ; Infant, Newborn ; Female ; Humans ; Premature Birth/prevention & control ; Dietary Supplements ; Pre-Eclampsia/prevention & control ; Fetus ; Arginine
Chemical Substances	Arginine (94ZLA3W45F)
Language	English
Publishing date	2023-05-31
Publishing country	England
Document type	Systematic Review ; Journal Article ; Review
ZDB-ID	2077261-0
ISSN	1476-4954 ; 1057-0802 ; 1476-7058
ISSN (online)	1476-4954
ISSN	1057-0802 ; 1476-7058
DOI	10.1080/14767058.2023.2217465
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Article ; Online: Combined oral contraceptive with estetrol plus drospirenone: from pharmacokinetics to clinical applications.

Battipaglia, Christian / Feliciello, Lia / Genazzani, Alessandro D / Facchinetti, Fabio / Grandi, Giovanni

Expert opinion on drug metabolism & toxicology

2024 Volume 19, Issue 12, Page(s) 871–879

Abstract: Introduction: Drospirenone/estetrol (DRSP/E4) is a combined oral contraceptive (COC) recently approved in several countries. It is composed of 15 mg of E4, a natural estrogen produced by human fetal liver throughout pregnancy, and 3 mg of DRSP, the ... ...

Abstract	Introduction: Drospirenone/estetrol (DRSP/E4) is a combined oral contraceptive (COC) recently approved in several countries. It is composed of 15 mg of E4, a natural estrogen produced by human fetal liver throughout pregnancy, and 3 mg of DRSP, the first synthetic progestin used in oral contraception derived from 17-α-spirolactone. E4 and DRSP synergistically prevent pregnancy by inhibiting ovulation. E4 differs from 17-β-estradiol or ethinylestradiol because it represents a native estrogen with selective action in tissues (NEST), therefore it displays both agonist and antagonist estrogenic effects in different tissues. Areas covered: In this paper, we reviewed the scientific literature published in English prior to April 2023 and gathered information on the pharmacodynamics and pharmacokinetics of DRSP, E4 and their combination for contraception. We also proposed possible clinical applications based on the characteristics of the components of this COC. Expert opinion: E4/DRSP-based COC has shown high tolerability, safety and satisfaction and may represent a viable choice in young girls in need of oral contraception and pill users who suffer from high cholesterol, breast tenderness or water retention. Moreover, this new COC shows higher scheduled bleeding rate compared to other pills containing natural estrogens. All the data are reassuring, permitting long-term use.
MeSH term(s)	Pregnancy ; Female ; Humans ; Contraceptives, Oral, Combined/pharmacology ; Estetrol/adverse effects ; Ethinyl Estradiol/pharmacology ; Estrogens ; Androstenes
Chemical Substances	Contraceptives, Oral, Combined ; Estetrol (ENB39R14VF) ; drospirenone (N295J34A25) ; Ethinyl Estradiol (423D2T571U) ; Estrogens ; Androstenes
Language	English
Publishing date	2024-01-12
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2214462-6
ISSN	1744-7607 ; 1742-5255
ISSN (online)	1744-7607
ISSN	1742-5255
DOI	10.1080/17425255.2023.2279752
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Zs.A 6264: Show issues

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Article ; Online: Postpartum contraception: A matter of guidelines.

Grandi, Giovanni / Del Savio, Maria C / Tassi, Alice / Facchinetti, Fabio

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

2023 Volume 164, Issue 1, Page(s) 56–65

Abstract: The postpartum period is the perfect time to access family planning services. WHO guidelines contraindicate combined hormonal contraceptives postpartum in breastfeeding patients between 6 weeks and 6 months after delivery (Medical Eligibility Criteria ... ...

Abstract	The postpartum period is the perfect time to access family planning services. WHO guidelines contraindicate combined hormonal contraceptives postpartum in breastfeeding patients between 6 weeks and 6 months after delivery (Medical Eligibility Criteria category 3). On the contrary, the Faculty of Sexual and Reproductive Healthcare and the Centers for Disease Control and Prevention guidelines do not contraindicate their use in women who breastfeed from 6 weeks to 6 months postpartum. New combined hormonal contraceptives with natural estrogens have never been studied in this setting. Guidelines agree on the prescription of the progestin-only pill postpartum in non-breastfeeding women (category 1). Differences are found in women who breastfeed. In non-breastfeeding women, an implant is considered safe (category 1) by all guidelines, without any distinction in time. Regarding postpartum breastfeeding women, the guidelines for implants give quite different indications but are still permissive. Intrauterine devices are viable options for postpartum contraception but guidelines give different indications about the timing of insertion. Postplacental intrauterine device placement can reduce the subsequent unintended pregnancy rate, particularly in settings at greatest risk of not having recommended postpartum controls. However, it has yet to be understood whether this approach can really have an advantage in high-income countries. Postpartum contraception is not a 'matter of guidelines': it is the best customization for each woman, as early as possible but at the ideal timing.
MeSH term(s)	Pregnancy ; Humans ; Female ; Contraception ; Postpartum Period ; Reproduction ; Family Planning Services ; Intrauterine Devices ; Contraceptive Agents
Chemical Substances	Contraceptive Agents
Language	English
Publishing date	2023-06-19
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80149-5
ISSN	1879-3479 ; 0020-7292
ISSN (online)	1879-3479
ISSN	0020-7292
DOI	10.1002/ijgo.14928
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Zs.A 355: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Progestogens for maintenance tocolysis in symptomatic women. A systematic review and meta-analysis.

Ferrari, Francesca / Minozzi, Silvia / Basile, Laura / Chiossi, Giuseppe / Facchinetti, Fabio

PloS one

2023 Volume 18, Issue 2, Page(s) e0277563

Abstract: Objective: Prevention of preterm birth (PTB) with progestogens after an episode of threatened preterm labour is still controversial. As different progestogens have distinct molecular structures and biological effects, we conducted a systematic review ... ...

Abstract	Objective: Prevention of preterm birth (PTB) with progestogens after an episode of threatened preterm labour is still controversial. As different progestogens have distinct molecular structures and biological effects, we conducted a systematic review and pairwise meta-analysis to investigate the individual role played by 17-alpha-hydroxyprogesterone caproate (17-HP), vaginal progesterone (Vaginal P) and oral progesterone (Oral P). Methods: The search was performed in MEDLINE, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials (CENTRAL) up to 31 October 2021. Published RCTs comparing progestogens to placebo or no treatment for maintenance tocolysis were considered. We included women with singleton gestations, excluding quasi-randomized trials, studies on women with preterm premature rupture of membrane, or receiving maintenance tocolysis with other drugs. Primary outcomes were preterm birth (PTB) < 37 weeks' and < 34 weeks'. We assessed risk of bias and evaluated certainty of evidence with the GRADE approach. Results: Seventeen RCTs including 2152 women with singleton gestations were included. Twelve studies tested vaginal P, five 17-HP, and only 1 oral P. PTB < 34 weeks' did not differ among women receiving vaginal P (RR 1.21, 95%CI 0.91 to 1.61, 1077 participants, moderate certainty of evidence), or oral P (RR 0.89, 95%CI 0.38 to 2.10, 90 participants, low certainty of evidence) as opposed to placebo. Instead, 17-HP significantly reduced the outcome (RR 0.72, 95% CI 0.54 to 0.95, 450 participants, moderate certainty of evidence). PTB < 37 weeks' did not differ among women receiving vaginal P (RR 0.95, 95%CI 0.72 to 1.26, 8 studies, 1231 participants, moderate certainty of evidence) or 17-HP (RR 0.86, 95%CI 0.60 to 1.21, 450 participants, low certainty of evidence) when compared to placebo/no treatment. Instead, oral P significantly reduced the outcome (RR 0.58, 95% CI 0.36 to 0.93, 90 participants, low certainty of evidence). Conclusions: With a moderate certainty of evidence, 17-HP prevents PTB < 34 weeks' gestation among women that remained undelivered after an episode of threatened preterm labour. However, data are insufficient to generate recommendations in clinical practice. In the same women, both 17-HP and vaginal P are ineffective in the prevention of PTB < 37 weeks'.
MeSH term(s)	Pregnancy ; Infant, Newborn ; Female ; Humans ; Progestins ; Progesterone ; Premature Birth/prevention & control ; Tocolysis ; Obstetric Labor, Premature/drug therapy
Chemical Substances	Progestins ; Progesterone (4G7DS2Q64Y)
Language	English
Publishing date	2023-02-22
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0277563
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Article ; Online: We don´t have elements to scare women who use oral contraceptives based on nomegestrol or chlormadinone about the risk of meningioma. Let's be careful and honest!

Grandi, Giovanni / Marani, Gianluca / Facchinetti, Fabio / Bahamondes, Luis

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

2022 Volume 27, Issue 5, Page(s) 355–356

MeSH term(s)	Chlormadinone Acetate ; Contraceptives, Oral, Combined/adverse effects ; Female ; Humans ; Male ; Megestrol/analogs & derivatives ; Meningeal Neoplasms ; Meningioma/chemically induced
Chemical Substances	Contraceptives, Oral, Combined ; Chlormadinone Acetate (0SY050L61N) ; nomegestrol (10F89177CO) ; Megestrol (EA6LD1M70M)
Language	English
Publishing date	2022-08-23
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	1397560-2
ISSN	1473-0782 ; 1362-5187
ISSN (online)	1473-0782
ISSN	1362-5187
DOI	10.1080/13625187.2022.2114792
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Article ; Online: Confirmation of the safety of combined oral contraceptives containing oestradiol on the risk of venous thromboembolism.

Grandi, Giovanni / Facchinetti, Fabio / Bitzer, Johannes

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

2022 Volume 27, Issue 2, Page(s) 83–84

MeSH term(s)	Contraceptives, Oral, Combined/adverse effects ; Desogestrel ; Estradiol/adverse effects ; Female ; Humans ; Risk Factors ; Venous Thromboembolism/chemically induced
Chemical Substances	Contraceptives, Oral, Combined ; Estradiol (4TI98Z838E) ; Desogestrel (81K9V7M3A3)
Language	English
Publishing date	2022-02-08
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	1397560-2
ISSN	1473-0782 ; 1362-5187
ISSN (online)	1473-0782
ISSN	1362-5187
DOI	10.1080/13625187.2022.2029397
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Article ; Online: Drospirenone 4 mg in a 24 + 4 regimen in women with contraindications to oestrogen use for contraception: bleeding patterns according to previous menstrual characteristics.

Grandi, Giovanni / Del Savio, Maria Chiara / Melotti, Chiara / Facchinetti, Fabio

Archives of gynecology and obstetrics

2022 Volume 307, Issue 3, Page(s) 873–879

Abstract: Purpose: A new POP consisting of 4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval was developed to improve bleeding predictability during POP use. The aim of this study was to evaluate the effect on bleeding patterns during use of ...

Abstract	Purpose: A new POP consisting of 4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval was developed to improve bleeding predictability during POP use. The aim of this study was to evaluate the effect on bleeding patterns during use of this oral contraceptive (OC) in comparison with previous menstrual cycles before the start of OC use. Methods: This is a pilot, prospective trial. A diary was used to collect information about daily bleeding and pelvic pain before and during treatment. During OC use, women were categorised as having (1) unscheduled bleeding or spotting days (UB), (2) scheduled bleeding or spotting days (SB) and (3) absence of bleeding/spotting (AB). SF-36 and FSFI questionnaires were used to quantify health-related quality of life and the quality of sexual life in sexually active participants. Results: Eighteen out of twenty-five (72%) women completed the entire follow-up. Women with UB (44.4%) were older at inclusion (p < 0.001) and had higher BMIs (p = 0.02) than those with AB (22.2%) or SB (33.4%). Women recorded a significant reduction of menstrual flow intensity during OC use (p < 0.0001). Those with UB also experienced a significant reduction of menstrual pain intensity (p = 0.006). Women with SB during OC use had a longer baseline cycle than those who reported UB during OC use (p = 0.008). Satisfaction with this OC was very high (8.4 ± 2.2 points) with no modification in SF-36 and FSFI values. Conclusion: A DRSP-only pill is a good OC option for women with contraindications to oestrogen use. Features of the menstrual cycle before the start of OC use may be used to predict associated changes in bleeding patterns.
MeSH term(s)	Female ; Humans ; Male ; Contraception ; Contraceptives, Oral ; Contraceptives, Oral, Combined ; Contraindications ; Estrogens ; Ethinyl Estradiol ; Menstrual Cycle ; Prospective Studies ; Quality of Life ; Pilot Projects
Chemical Substances	Contraceptives, Oral ; Contraceptives, Oral, Combined ; drospirenone (N295J34A25) ; Estrogens ; Ethinyl Estradiol (423D2T571U)
Language	English
Publishing date	2022-11-21
Publishing country	Germany
Document type	Clinical Trial ; Journal Article
ZDB-ID	896455-5
ISSN	1432-0711 ; 0932-0067
ISSN (online)	1432-0711
ISSN	0932-0067
DOI	10.1007/s00404-022-06853-1
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Article ; Online: It is time to talk about replacement of subdermal implants from the same cut, is it always feasible? The slow process of the "armpit approach".

Grandi, Giovanni / Feliciello, Lia / Negro, Giulia / Sgandurra, Alice / Facchinetti, Fabio

European journal of obstetrics, gynecology, and reproductive biology

2022 Volume 274, Page(s) 253–254

MeSH term(s)	Axilla ; Contraceptive Agents, Female ; Drug Implants ; Female ; Humans ; Levonorgestrel
Chemical Substances	Contraceptive Agents, Female ; Drug Implants ; Levonorgestrel (5W7SIA7YZW)
Language	English
Publishing date	2022-05-18
Publishing country	Ireland
Document type	Letter
ZDB-ID	190605-7
ISSN	1872-7654 ; 0301-2115 ; 0028-2243
ISSN (online)	1872-7654
ISSN	0301-2115 ; 0028-2243
DOI	10.1016/j.ejogrb.2022.05.013
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