Please use this identifier to cite or link to this item: doi:10.22028/D291-21153
Title: Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive : results of two prospective, randomized, open-label studies
Author(s): Endrikat, Jan
Parke, Susanne
Trummer, Dietmar
Schmidt, Werner
Duijkers, Ingrid
Klipping, Christine
Language: German
Year of Publication: 2008
OPUS Source: Contraception. - 78. 2008, 3, S. 218-225
DDC notations: 610 Medicine and health
Publikation type: Journal Article
Abstract: 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 to this record: urn:nbn:de:bsz:291-scidok-16772
Date of registration: 16-Sep-2009
Faculty: M - Medizinische Fakultät
Department: M - Frauenheilkunde
Collections:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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