The Use of Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.

Start Date01 Jan 2023

Sponsor / Collaborator

University of Palermo

[+1]

NCT06324851 / CompletedPhase 4IIT

The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.

Start Date01 Jan 2023

Sponsor / Collaborator

University of Palermo

[+1]

NCT03945513 / CompletedPhase 3

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424 (Dienogest 2 mg / Ethinyl Estradiol 0.02 mg) During 13 Cycles

The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.

Start Date03 Dec 2019

Sponsor / Collaborator

Insud Pharma SL

[+1]

100 Clinical Results associated with Ethinyl Estradiol/Dienogest

100 Translational Medicine associated with Ethinyl Estradiol/Dienogest

100 Patents (Medical) associated with Ethinyl Estradiol/Dienogest

Literatures (Medical) associated with Ethinyl Estradiol/Dienogest

01 Jan 2003·British Journal of Clinical Pharmacology

Unwanted pregnancy on self‐medication with St John's wort despite hormonal contraception

Letter

Author: W. Kirch ; Barbara Büschel ; Ute I. Schwarz

Many patients take St John's wort (SJW, Hypericum perforatum), a herbal remedy, to treat symptoms of depression, often without the knowledge of their physician. Widely available without prescription, it is considered by some to be a safe because it is a ‘natural’ alternative to more traditional antidepressants. Recent reports indicate that SJW has been implicated in numerous herb–drug interactions that may have clinical significance [1]. Women taking oral contraceptives and SJW have reported breakthrough menstrual bleeding, but this is the first published case of an unexpected pregnancy in association with SJW consumption [2]. A 36-year-old woman with depression and hypercholesterolaemia presented to a gynaecology practice with an unexpected pregnancy confirmed by ultrasound. the drug history revealed regular use of the combined oral contraceptive Valette® (ethinyl oestradiol/dienogesterol) over the last year. She had been treated with fluvastatin (20 mg day−1) for 2 years, and with different antidepressants including selective serotonin reuptake inhibitors and tricyclic antidepressants after an attempted suicide in 1995. the patient began self-medicated with the over-the-counter Hypericum extract Helarium®425 (Bionorica) with daily doses up to 1700 mg approximately 3 months prior to conception, and until conception no other medication was taken except the hormonal contraceptive. aA therapeutic abortion was carried out and revealed a healthy, 17-week-old, 144 g male foetus. Co-administration of SJW has resulted in markedly reduced blood levels of drugs such as cyclosporin, indinavir, and digoxin. Lowered levels of cyclosporin have contributed to the rejection of transplanted organs [3]. in healthy volunteers, 10–14 days of concomitant SJW resulted in 81% reduction of indinavir trough and 30% reduction of plasma digoxin concentrations [4, 5]. This effect is likely mediated through induction of the drug metabolizing enzyme cytochrome P450 3a (CYP3a) and the efflux transporter P-glycoprotein that is encoded by the multidrug resistance gene MDR1[6]. Hyperforin, a major phytochemical present in SJW, is a potent activator of the human nuclear receptor pregnane X (PXR) [7]. Both CYP3A4 and MDR1 have PXR response elements in their 5′-upstream regulatory regions, and activation will lead to enhanced expression of the encoded proteins [8, 9]., Clinical studies with the antibiotic rifampin, like SJW a potent inducer of CYP3a and P-glycoprotein, have demonstrated a significant decrease of the mean AUC of ethinyl estradiol and norethindrone in healthy women [9, 10]. As the steroid hormone estradiol is subject to P-glycoprotein- efflux and CYP3a metabolism, induction can lead to enhanced elimination of the hormone that would lead to ineffective contraception [11, 12]. Four other cases of ineffective contraception coincident with SJW consumption have been reported to the German authorities (German Federal Institute for Drugs and Medical Devices, Drug Commission of the German Medical Profession). Because of this pharmacokinetic interaction, alternative methods of contraception are strongly recommended when SJW is used. Accurate information regarding drug interactions and the potential failure of oral contraceptives should be provided to consumers of SJW. Thus far, product information accompanying Hypericum extracts does not adequately describe the potential risk for herb–drug interactions.

01 Apr 2001·Die Pharmazie

Non-protein bound dienogest in serum and salivary dienogest in women taking the oral contraceptives Certostat and Valette.

Article

Author: Schön, R ; Hobe, G ; Jäger, R ; Küntzel, B ; Piater, T ; Klinger, G

Dienogest (17 alpha-cyanomethyl-17-hydroxy-4,9-estradien-3-one) is the progestagen component of the oral contraceptives Certostat and Valette. In contrast to other 19-norsteroid progestagens like levonorgestrel, norethisterone, gestodene and 3-ketodesogestrel, dienogest does not bind to sexual hormone binding globulin (SHBG). The absent binding to SHBG results in a high portion of free, non-protein bound dienogest in serum. In female volunteers taking the oral contraceptives Certostat and Trisiston, the part of non-protein bound dienogest and levonorgestrel, respectively, in serum was determined by the method of centrifugal ultrafiltration. The portion of free dienogest was found to be 9.55 +/- 0.95% (m +/- SD, n = 13) of total serum dienogest. Free levonorgestrel constituted 0.97 +/- 0.14% (n = 12) of total serum levonorgestrel. In an investigation with 47 female volunteers taking Certostat, serum total dienogest was quantified by a specific radioimmunoassay and free dienogest in serum by centrifugal ultrafiltration. In the serum samples with dienogest concentrations in the range of 4.1-57.7 ng/ml, the part of free, non-protein bound dienogest was found to be 8.90 +/- 0.54% of serum total dienogest. There is a high correlation between serum total dienogest and free dienogest (r = 0.989). In another investigation with 20 female volunteers taking the contraceptive Valette, serum total dienogest and salivary dienogest were quantified by radioimmunoassay and free dienogest in serum by centrifugal ultrafiltration. In the serum samples with dienogest concentrations in the range of 7.5-50.6 ng/ml, the part of free, non-protein bound dienogest was 8.78 +/- 0.77% of serum total dienogest. Salivary dienogest constituted 7.99 +/- 0.94% of serum total dienogest showing a high correlation with serum free dienogest (r = 0.953) and serum total dienogest (r = 0.958). The high portion of non-protein bound compound in serum is a characteristic pharmacokinetic feature of dienogest.

01 Jun 2000·Journal of Clinical Pharmacy and TherapeuticsQ4 · MEDICINE

Effect of oral contraceptives on the urinary excretion of biochemical markers indicating vasoactive action

Q4 · MEDICINE

Article

Author: Wallwiener D ; Gräser T ; Mueck Ao ; Lüdtke R ; Seeger H

OBJECTIVEIn the present study the effect of two contraceptive pills, i.e. Neorlest, containing ethinylestradiol and norethisterone acetate, and Valette, containing ethinylestradiol and the new progestin dienogest, was investigated on the urinary excretion of vasoactive markers. As markers prostacyclin and its antagonist thromboxane, cGMP, serotonin, and the vasorelaxing mediators relaxin and urodilatin were measured.METHOD30 women received Neorlest and 33 women Valette in a randomized, open, parallel-group study design. Nocturnal urine was collected before treatment and during cyclic treatment after 6 and 11 weeks.RESULTSFor prostacyclin, the ratio of prostacyclin to thromboxane, relaxin and urodilatin significant increases compared to the pretreatment values were observed with Valette within 11 weeks treatment. For the markers cGMP and serotonin both contraceptive pills showed a tendency to an increase of the renal excretion after 11 weeks treatment. No significant differences between the two pills were observed, except in the case of the ratio of prostacyclin to thromboxane, which showed a significant, clear-cut enhancement with Valette.CONCLUSIONThese results indicate that contraceptive pills may stimulate the production of vasodilative markers, an effect which can be attributed most likely to the oestrogenic component of the pill. The progestogenic component of the pill may elicit an impact on this oestrogen-induced vasodilation, which, however, seems to be minimized in the case of the new compound dienogest, a C-19 progestin with antiandrogenic properties.

100 Deals associated with Ethinyl Estradiol/Dienogest

External Link

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Contraception	-	Jenapharm GmbH & Co. KG	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 3	US	Insud Pharma SL	03 Dec 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02352090 (SYLVI, CTgov)	Phase 4	Inflammation \| Contraception	59	Ethinyl estradiol / dienogest (Synthetic Estrogen + Progestin)	uuxyaqrmlc(yjvuopqdzu) = lqkaimhqkl tjmgqcevns (rjjlwsrfxn, svycjpqqkt - zlgfzqabna) View more	-	29 Jun 2021
				Estradiol valerate / dienogest (Natural Estrogen + Progestin)	uuxyaqrmlc(yjvuopqdzu) = gquxashuqc tjmgqcevns (rjjlwsrfxn, apevjtwzdn - ehsnxosxzk) View more

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