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Article ; Online: Drospirenone 4 mg in a 24/4 regimen maintains inhibition of ovulation even after a 24-h delay pill intake - Pharmacological aspects and comparison to other progestin-only pills.

Regidor, P-A / Colli, E

European review for medical and pharmacological sciences

2022 Volume 26, Issue 6, Page(s) 1994–1999

Abstract: This review focuses on the pharmacological and inhibition of the ovulation of progestin-only, estrogen-free contraceptive containing drospirenone in a dosage of 4 mg in a regimen 24/4. The USA and European regulatory authorities have approved it. The ... ...

Abstract	This review focuses on the pharmacological and inhibition of the ovulation of progestin-only, estrogen-free contraceptive containing drospirenone in a dosage of 4 mg in a regimen 24/4. The USA and European regulatory authorities have approved it. The molecule has anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. This regime improves the bleeding profile, maintains the plasma E2 levels comparable to the menstrual cycle's early follicular phase, avoids hypoestrogenism, and preserves efficacy despite forgetting the tablet intake as drospirenone has a half lifetime of 30-34 hours. Clinical studies have shown good efficacy, very low cardiovascular side effects, and high acceptability and maintenance of ovulation inhibition after scheduled 24-h delays in pill intake. The molecule is compared to other POP like levonorgestrel or desogestrel.
MeSH term(s)	Androstenes/adverse effects ; Female ; Humans ; Ovulation ; Ovulation Inhibition ; Progestins/pharmacology
Chemical Substances	Androstenes ; Progestins ; drospirenone (N295J34A25)
Language	English
Publishing date	2022-05-09
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	605550-3
ISSN	2284-0729 ; 1128-3602 ; 0392-291X
ISSN (online)	2284-0729
ISSN	1128-3602 ; 0392-291X
DOI	10.26355/eurrev_202203_28348
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Article ; Online: Correction to: Bone health in estrogen-free contraception.

Hadji, P / Colli, E / Regidor, P-A

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

2022 Volume 31, Issue 7, Page(s) 1399

Language	English
Publishing date	2022-02-01
Publishing country	England
Document type	Published Erratum
ZDB-ID	1064892-6
ISSN	1433-2965 ; 0937-941X
ISSN (online)	1433-2965
ISSN	0937-941X
DOI	10.1007/s00198-020-05426-9
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Article ; Online: Improvement in menopausal symptoms with a nutritional product containing evening primrose oil, hop extract, saffron, tryptophan, vitamins B6, D3, K2, B12, and B9.

Palacios, S / Mustata, C / Rizo, J M / Regidor, P A

European review for medical and pharmacological sciences

2023 Volume 27, Issue 17, Page(s) 8180–8189

Abstract: ... A decrease in the MRS of all menopausal symptoms was observed after 12 weeks compared to baseline (p < 0 ...

Abstract	Objective: Safety concerns or contraindications in the use of hormones have resulted in a rise in the use of nutritional medicinal products for the management of menopausal symptoms. The aim of the present study was to demonstrate the efficacy and safety of Exelvit Menopause®. Patients and methods: A prospective, open, observational, and multicentre study was performed, including 156 menopausal women. The patients received the nutritional product containing evening primrose oil 50 mg; hop extract 0.127-0.212 mg; saffron Stigmas Extract 0.6 mg; tryptophan 71.25 mg, vitamins B6, D3, K2, B12, and B9 once per day for 12 weeks. The validated menopausal rating score (MRS) was used for recording symptoms. Results: A decrease in the MRS of all menopausal symptoms was observed after 12 weeks compared to baseline (p < 0. 0001). Overall, hot flashes were reduced by 48.15%, heart discomfort by 33.3%, sleep disturbance by 46.2%, joint and muscular discomfort by 27.8%, depressive mood by 45.0%, irritability by 47.6%, anxiety by 44.4%, physical problems by 36.4%, sexual problems by 30.0%, bladder problems 31.3%, and vaginal dryness by 33.3%. Conclusions: The nutritional product Exelvit Menopause® significantly reduced menopausal symptoms.
MeSH term(s)	Humans ; Female ; Vitamin B 6 ; Crocus ; Tryptophan ; Prospective Studies ; Menopause ; Biological Products ; Vitamins ; Plant Extracts/therapeutic use
Chemical Substances	Vitamin B 6 (8059-24-3) ; evening primrose oil (3Q9L08K71N) ; Tryptophan (8DUH1N11BX) ; Biological Products ; Vitamins ; Plant Extracts
Language	English
Publishing date	2023-09-26
Publishing country	Italy
Document type	Multicenter Study ; Journal Article
ZDB-ID	605550-3
ISSN	2284-0729 ; 1128-3602 ; 0392-291X
ISSN (online)	2284-0729
ISSN	1128-3602 ; 0392-291X
DOI	10.26355/eurrev_202309_33578
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Article ; Online: 10-month retrospective study on compliance and tolerability of the drospirenone-only pill.

Palacios, S / Colli, E / de Diego, M V / Regidor, P-A

European review for medical and pharmacological sciences

2022 Volume 27, Issue 7, Page(s) 2987–2993

Abstract: Objective: The current study evaluated menstrual bleeding profiles, compliance and tolerability in women using a drospirenone (DRSP)-only pill.: Patients and methods: This is a non-interventional, retrospective, multi-center study on healthy female ... ...

Abstract	Objective: The current study evaluated menstrual bleeding profiles, compliance and tolerability in women using a drospirenone (DRSP)-only pill. Patients and methods: This is a non-interventional, retrospective, multi-center study on healthy female adults [n=276, aged between 18 and 53 years and premenopausal using a DRSP-only pill for at least six months with a mean duration of 10.4 months (+/-SD 4.0) months]. 75.6% used other contraceptives than POP before starting with the DRSP-only pill. A questionnaire was used to evaluate the bleeding profile. 56.5% of the women had associated cardiovascular risk factors. Results: Two hundred and sixty-two (262) women (mean age of 32.5 ± 9.1 years; mean BMI of 23.1 ± 3.8 kg/m²) were eligible for analysis. 42.6% of the users had a scheduled bleeding, 33,3% unscheduled bleeding and 48% no bleeding during the last evaluable cycle. 75.4% evaluated the bleeding profile in the last cycle as very good or good, 13.8% said there was no change since starting the medication, 8.4% declared the profile was bad and 2.3% as very bad. 87.8% of the users evaluated the general satisfaction of the contraception as very good or good, whereas only 8.8% and 3.4% said there was no change or that it was bad. No women evaluated the general satisfaction as very bad. Conclusions: These data demonstrate that the DRSP-only pill is associated with a very high satisfaction as a contraceptive in general and in the individual bleeding profile. These aspects reaffirm the acceptability not only in women with cardiovascular risk factors.
MeSH term(s)	Humans ; Female ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Mineralocorticoid Receptor Antagonists/administration & dosage ; Mineralocorticoid Receptor Antagonists/pharmacology ; Retrospective Studies ; Menstruation ; Heart Disease Risk Factors ; Drug Tolerance
Chemical Substances	drospirenone (N295J34A25) ; Mineralocorticoid Receptor Antagonists
Language	English
Publishing date	2022-10-11
Publishing country	Italy
Document type	Multicenter Study ; Journal Article
ZDB-ID	605550-3
ISSN	2284-0729 ; 1128-3602 ; 0392-291X
ISSN (online)	2284-0729
ISSN	1128-3602 ; 0392-291X
DOI	10.26355/eurrev_202304_31931
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Article ; Online: Pharmacological and metabolic effects of drospirenone as a progestin-only pill compared to combined formulations with estrogen.

Regidor, Pedro-Antonio / Mueller, Anna / Mayr, Manuela

Women's health (London, England)

2023 Volume 19, Page(s) 17455057221147388

Abstract: The spironolactone derivative drospirenone is combined with ethinylestradiol or estetrol in combined oral contraceptives. Formulations with 17-β-estradiol are used to treat climacteric symptoms. A drospirenone-only formulation has been introduced for ... ...

Abstract	The spironolactone derivative drospirenone is combined with ethinylestradiol or estetrol in combined oral contraceptives. Formulations with 17-β-estradiol are used to treat climacteric symptoms. A drospirenone-only formulation has been introduced for contraception. Here, the pharmacological properties of drospirenone, the impact of the different formulations on metabolic and laboratory parameters, and the resulting clinical implications are reviewed. Ethinylestradiol, an inhibitor of CYP metabolic enzymes, changes the pharmacokinetics of drospirenone, leading to a higher drospirenone exposure with ethinylestradiol/drospirenone compared to the drospirenone-only preparation. In addition, several metabolic alterations have been described. The impact of estetrol is less pronounced, and for 17-β-estradiol/drospirenone and drospirenone-only, decreased triglyceride and cholesterol levels were observed. Ethinylestradiol induces various pro-coagulatory factors, leading to hypercoagulability. The effect is significantly reduced with estetrol, and no influence was observed with the drospirenone-only preparation. The anti-mineralocorticoid activity of drospirenone seems to positively counteract the renin-angiotensin-aldosterone-system-activating action of ethinylestradiol. There is no influence on blood pressure with ethinylestradiol/drospirenone and estetrol/drospirenone formulations, while in clinical trials, a reduction has been observed with 17-β-estradiol/drospirenone and drospirenone-only. Anti-aldosterone activity via non-renal mineralocorticoid receptors is associated with cardiovascular health, while interactions with parathyroid hormone signaling impact bone structure and vascular calcification. Though the clinical relevance is unclear for drospirenone, data in this context are reviewed. To sum up, the advantages of drospirenone in hormonal contraception and treatment of menopausal symptoms have been demonstrated for all the formulations described here. Combination with estrogen confers benefits and risks, which must be considered.
MeSH term(s)	Female ; Humans ; Progestins/pharmacology ; Estetrol ; Estrogens/pharmacology ; Ethinyl Estradiol/pharmacology ; Contraceptives, Oral, Combined/pharmacokinetics ; Estradiol/therapeutic use
Chemical Substances	Progestins ; drospirenone (N295J34A25) ; Estetrol (ENB39R14VF) ; Estrogens ; Ethinyl Estradiol (423D2T571U) ; Contraceptives, Oral, Combined ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2023-02-06
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	10.1177/17455057221147388
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Article: Progesterone in Peri- and Postmenopause: A Review.

Regidor, P-A

Geburtshilfe und Frauenheilkunde

2014 Volume 74, Issue 11, Page(s) 995–1002

Abstract: Around 14.5 million peri- and postmenopausal women currently live in Germany. Moreover, approximately 450 000 women, each with a life expectancy of around 85 years, reach menopause every year in Germany. The challenge is therefore to find a therapy with ... ...

Abstract	Around 14.5 million peri- and postmenopausal women currently live in Germany. Moreover, approximately 450 000 women, each with a life expectancy of around 85 years, reach menopause every year in Germany. The challenge is therefore to find a therapy with few side effects which could improve the quality of life of women with menopausal symptoms. The aim of hormone therapy (HT) is to remedy hormone deficiencies using substances that offer the best trade-off between benefits and risks. This is where progesterone has a new and important role to play. Progesterone is one of the most important gestagens. Biologically effective progesterone formulations created with micronization techniques have been used in clinical practice since 1996. Nevertheless, up until 2003 preference was given to synthetic gestagens rather than progesterone. The increased breast cancer hazard ratio of 1.23 reported in the WHI study and of 2 given in the Million Women Study has been associated with the use of synthetic gestagens. In a comparison between synthetic gestagens and progesterone, the E3N Study showed that the transdermal administration of estrogen and progesterone did not lead to an increase in breast cancer rates (RR: 1.08). The administration of progesterone does not change the HDL/LDL cholesterol ratio. Because of its anti-mineralocorticoid effect, progesterone has no impact on carbohydrate metabolism, hemostasis, blood pressure, thrombogenicity and body weight. The administration of 200 mg/day progesterone over 12 days of a menstrual cycle or a daily administration of 100 mg combined with an estrogen are a safe and well-tolerated option to treat menopausal symptoms, with a better benefit risk profile compared to synthetic gestagens.
Language	English
Publishing date	2014-11
Publishing country	Germany
Document type	Journal Article
ZDB-ID	80111-2
ISSN	1438-8804 ; 0016-5751 ; 1615-3359
ISSN (online)	1438-8804
ISSN	0016-5751 ; 1615-3359
DOI	10.1055/s-0034-1383297
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Article: Hormonelle Beeinflussung der Menstruation

Regidor, P.-A.

Der Frauenarzt

2016 Volume 57, Issue 3, Page(s) 282

Language	German
Document type	Article
ZDB-ID	80364-9
ISSN	0016-0237
Database	Current Contents Medicine

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Article ; Online: Evaluation of the food effect on a drospirenone only contraceptive containing 4 mg administered with and without high-fat breakfast in a randomised trial.

Regidor, P-A / Richter, W H / Koytchev, R / Kirkov, V / Colli, E

BMC women's health

2022 Volume 22, Issue 1, Page(s) 381

Abstract: ... for the endpoint, intra-individual ratio (Test 'A' = with food intake) vs. Test 'B' = without food intake) of AUC(0 ... for the endpoint intra-individual ratio (Test 'A' vs. Test 'B') of Cmax of DRSP was between 118.58 and 141.10 ... The mean relative bioavailability of the test with food 'A' compared to the Test without food 'B' after ...

Abstract	Background: The objective of the present trial was to assess the difference in pharmacokinetics (PK) of an oral test preparation containing 4 mg drospirenone (DRSP) under fasting conditions compared to PK upon food intake after single dose administration. Methods: Open label, single centre, two-treatment, two-sequence, crossover study in 24 healthy female volunteers, with duration of 1 day per sequence and with a real wash-out period of 14 days to investigate the relative bioavailability of DRSP with both forms of administration. The 90% confidence intervals (CI) were calculated for the intra-individual ratio (test with food vs. without food) of the PK endpoints Area under the curve; 0-72 h [AUC(0-72 h Results: The 90% CI calculated by analysis of variance using logistic transformation (ANOVA-log) for the endpoint, intra-individual ratio (Test 'A' = with food intake) vs. Test 'B' = without food intake) of AUC(0-72 h) of drospirenone was between 104.72 and 111.36%. The 90% CI calculated by means of ANOVA- log for the endpoint intra-individual ratio (Test 'A' vs. Test 'B') of Cmax of DRSP was between 118.58 and 141.10%. The mean relative bioavailability of the test with food 'A' compared to the Test without food 'B' after single dose administration based on the endpoints AUC(0-72 h Conclusions: The rate of absorption, based on the endpoint Cmax of DRSP was increased by about 30% under fed conditions. With respect to consumer habits, this may represent a relevant benefit for contraceptive safety, as the time span between food consumption and pill intake does not play a role. Implications: Our results suggest that the food intake has no impact on the absorption of 4 mg DRSP in the management of contraception. This increases the contraceptive efficacy as no interference with food is expected when consuming the oral formulation under real life conditions. Trail registration: Trial registration number: EudraCT-No: 2012-004,309-28.
MeSH term(s)	Androstenes/pharmacokinetics ; Breakfast/drug effects ; Contraceptive Agents/pharmacokinetics ; Cross-Over Studies ; Dietary Fats/administration & dosage ; Female ; Humans
Chemical Substances	Androstenes ; Contraceptive Agents ; Dietary Fats ; drospirenone (N295J34A25)
Language	English
Publishing date	2022-09-19
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2050444-5
ISSN	1472-6874 ; 1472-6874
ISSN (online)	1472-6874
ISSN	1472-6874
DOI	10.1186/s12905-022-01960-2
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Article ; Online: Bone health in estrogen-free contraception.

Hadji, P / Colli, E / Regidor, P-A

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

2019 Volume 30, Issue 12, Page(s) 2391–2400

Abstract: Estrogens and progestogens influence the bone. The major physiological effect of estrogen is the inhibition of bone resorption whereas progestogens exert activity through binding to specific progesterone receptors. New estrogen-free contraceptive and its ...

Abstract	Estrogens and progestogens influence the bone. The major physiological effect of estrogen is the inhibition of bone resorption whereas progestogens exert activity through binding to specific progesterone receptors. New estrogen-free contraceptive and its possible implication on bone turnover are discussed in this review. Insufficient bone acquisition during development and/or accelerated bone loss after attainment of peak bone mass (PBM) are 2 processes that may predispose to fragility fractures in later life. The relative importance of bone acquisition during growth versus bone loss during adulthood for fracture risk has been explored by examining the variability of areal bone mineral density (BMD) (aBMD) values in relation to age. Bone mass acquired at the end of the growth period appears to be more important than bone loss occurring during adult life. The major physiological effect of estrogen is the inhibition of bone resorption. When estrogen transcription possesses binds to the receptors, various genes are activated, and a variety modified. Interleukin 6 (IL-6) stimulates bone resorption, and estrogen blocks osteoblast synthesis of IL-6. Estrogen may also antagonize the IL-6 receptors. Additionally, estrogen inhibits bone resorption by inducing small but cumulative changes in multiple estrogen-dependent regulatory factors including TNF-α and the OPG/RANKL/RANK system. Review on existing data including information about new estrogen-free contraceptives. All progestins exert activity through binding to specific progesterone receptors; hereby, three different groups of progestins exist: pregnanes, gonanes, and estranges. Progestins also comprise specific glucocorticoid, androgen, or mineralocorticoid receptor interactions. Anabolic action of a progestogen may be affected via androgenic, anti-androgenic, or synadrogenic activity. The C 19 nortestosterone class of progestogens is known to bind with more affinity to androgen receptors than the C21 progestins. This article reviews the effect of estrogens and progestogens on bone and presents new data of the currently approved drospirenone-only pill. The use of progestin-only contraceptives leading to an estradiol level between 30 and 50 pg/ml does not seem to lead to an accelerate bone loss.
MeSH term(s)	Age Factors ; Androstenes/pharmacology ; Bone Density/drug effects ; Bone Density/physiology ; Bone Development/physiology ; Bone Remodeling/drug effects ; Bone Remodeling/physiology ; Bone Resorption/blood ; Bone Resorption/physiopathology ; Contraceptives, Oral, Combined/pharmacology ; Contraceptives, Oral, Hormonal/chemistry ; Contraceptives, Oral, Hormonal/pharmacology ; Estradiol/blood ; Estrogens/physiology ; Female ; Humans ; Progestins/pharmacology
Chemical Substances	Androstenes ; Contraceptives, Oral, Combined ; Contraceptives, Oral, Hormonal ; Estrogens ; Progestins ; Estradiol (4TI98Z838E) ; drospirenone (N295J34A25)
Language	English
Publishing date	2019-08-24
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1064892-6
ISSN	1433-2965 ; 0937-941X
ISSN (online)	1433-2965
ISSN	0937-941X
DOI	10.1007/s00198-019-05103-6
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Article: Beeinflussung der Menstruation durch Antikonzeption und Menopause - Menstruationshäufigkeit und Lebensqualität

Regidor, P.-A.

Gyn-aktiv

2015 Volume -, Issue 6, Page(s) 38

Language	German
Document type	Article
ZDB-ID	2213296-X
ISSN	1605-8828
Database	Current Contents Medicine

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