Monophasic gestodene and ethinylestradiol in oral contraception: A multicenter open study

Aguiar, L. F.; Andrade, Rosíres Pereira de; Bossemeyer, R; Hegg, R.; Filho, Carlos Isaia; Leal, J. W. B.; Munhoz, Claudio; Pinto, Aquije; Rubin, Joan

doi:10.3109/09513599609049605

Cited by 2 publications

(4 citation statements)

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“…Blood samples (06 mL) were collected by indwelling catheter into EDTA containing tubes before dosing and 15, 30, 45 min and also 1, 1.25, 1.5, 1.75, 2, 2.50, 3,4,6,8,12,16,24,36,48,72, 96 h post-dosing for ethinylestradiol and gestodene. The blood samples were centrifuged at 3.000 rpm for 10 min.…”

Section: Study Proceduresmentioning

confidence: 99%

“…These will vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), and follicle-stimulating hormone (FSH), through a negative feedback mechanism [1][2][3][4]. Modern progestogens such as gestodene have been developed in order to provide women with an oral contraceptive agent with more selective progestational activity that improves cycle control, minimizes metabolic changes and adverse events, and effectively prevents pregnancy [1].…”

Section: Introductionmentioning

confidence: 99%

“…Gestodene has been combined with low doses of ethinylestradiol to provide low-dose combination oral contraceptive (COC) preparations. While low-dose COCs are the most widely prescribed form of oral contraceptive today and have a low failure rate in terms of unintended pregnancies, approximately 50% of all women who begin taking oral contraceptives discontinue their use within one year [3]. Of the factors attributed to noncompliance and/or discontinuation of a COC preparation, poor cycle control (ie, spotting, breakthrough bleeding, and amenorrhea) is the most frequently cited reason for discontinuation.…”

Section: Introductionmentioning

confidence: 99%

“…Of the factors attributed to noncompliance and/or discontinuation of a COC preparation, poor cycle control (ie, spotting, breakthrough bleeding, and amenorrhea) is the most frequently cited reason for discontinuation. Headache, weight gain, and breast tenderness are also frequently cited reasons for COC discontinuation [3]. As demonstrated by the data presented in the Clinical Experience, Clinical Safety and Tolerability the gestodene-containing COC preparation, effectively combines ethinylestradiol and gestodene to provide high contraceptive efficacy with good cycle control, minimal changes in metabolic functions, and a low incidence of common COC side effects [17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

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Bioequivalence of Two Oral Contraceptive Drugs Containing Ethinylestradiol and Gestodene in Healthy Female Volunteers

Abib¹,

Duarte²,

Vanunci³

et al. 2010

JBB

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The bioavailability and bioequivalence of two different film coated tablets containing ethinylestradiol and gestodene were investigated in 36 healthy female volunteers after oral single-dose administration. The study was performed according to a single-center, randomized, single-dose, 2-way cross-over design with a wash-out phase of 28 days. Blood samples for pharmacokinetic profiling were taken postdose up to 72 h (ethinylestradiol) and 96 h (gestodene). Ethinylestradiol and gestodene plasma concentrations were determined with a validated LC-MS/MS method. Bioequivalence between the products was determined by calculating 90% confidence intervals (90% I.C) for the ratio of AUC 0-t and C max values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals of ethinylestradiol were 98.49%-109.19%, and 100.62%-111.69%, respectively. The 90% confidence intervals of gestodene were 94.07%-105.91%, and 110.19%-124.73%, respectively. Since the 90% confidence intervals for C max and AUC 0-t were within the 80-125% interval proposed by Food and Drug Administration, it was concluded that the two ethinylestradiol and gestodene formulations are bioequivalent in their rate and extent of absorption.

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