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Titel: Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive : results of two prospective, randomized, open-label studies
Verfasser: Endrikat, Jan
Parke, Susanne
Trummer, Dietmar
Schmidt, Werner
Duijkers, Ingrid
Klipping, Christine
Sprache: Deutsch
Erscheinungsjahr: 2008
Quelle: Contraception. - 78. 2008, 3, S. 218-225
DDC-Sachgruppe: 610 Medizin, Gesundheit
Dokumentart : Journalartikel
Kurzfassung: Background: Attempts to improve the tolerability of combined oral contraceptives (COCs) have included the substitution of ethinylestradiol (EE) with 17beta-estradiol (E2). However, this has proved unsatisfactory, specifically in terms of cycle control. To improve upon the poor cycle control seen previously, E2 (in the form of estradiol valerate [E2V], 1 mg E2V contains 0.76 mg E2) was combined with dienogest (DNG) in a novel four-phasic regimen. In the current studies the ovulation inhibition potency of four variations of this regimen was assessed. Study design: Two randomized, open-label, phase II studies were performed. The first study compared two regimens (1A, 2A) with similar dosages of DNG but different lengths of application. Having established in Study 1 that the length of application of regimen 2A was most suitable but that the dosages of DNG were too low for effective ovulation inhibition, a second study was undertaken, which compared two regimens (2B, 2C) with similar lengths of application but increased dosages of DNG. The primary efficacy variable in both studies was the proportion of women with a Hoogland score of 5/6 during Cycle 2. Results: The full analysis set comprised 192 and 203 women in Study 1 and 2, respectively. In Study 1, 10 women (10.9%) in regimen 1A and 6 women (6.4%) in regimen 2A had a Hoogland score of 5/6. In Study 2, 3 women (3.1 %) in regimen 2B and 1 woman (1.0%) in regimen 2C had a Hoogland score of 5/6. There were no safety concerns with any of the regimens.
Link zu diesem Datensatz: urn:nbn:de:bsz:291-scidok-16772
hdl:20.500.11880/21209
http://dx.doi.org/10.22028/D291-21153
SciDok-Publikation: 16-Sep-2009
Fakultät: Fakultät 2 - Medizin
Fachrichtung: M - Frauenheilkunde
Fakultät / Institution:M - Medizinische Fakultät

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