Orale Gestagene in der hormonellen Kontrazeption: Stellenwert und Zukunftsaussichten eines neuen Gestagen-Monopräparats mit 4 mg Drospirenon

Zusammenfassung

Hormonelle Kontrazeptiva stellen eine effektive und sichere Methode der Schwangerschaftsverhütung dar. Die Gestagene, die in der Kontrazeption verwendet werden, sind entweder Bestandteil kombinierter hormoneller Kontrazeptiva (Tabletten, Pflaster oder Vaginalringe) oder werden als einzelner Wirkstoff in Gestagen-Monopräparaten (Tabletten [im englischen Sprachgebrauch „POP“ = Progestin-only-Pill], Implantate, Intrauterinsysteme oder Depotpräparate) eingesetzt. Gestagene sind in der Langzeitverhütung bei adäquater Anwendung höchst effektiv und haben ein sehr gutes Sicherheitsprofil mit nur wenigen Kontraindikationen. Kürzlich wurde ein neuer östrogenfreier Ovulationshemmer (POP) in den USA und der EU zugelassen. Das Gestagen-Monopräparat enthält 4 mg Drospirenon (DRSP), welches antigonadotrope, antimineralokortikoide und antiandrogene Eigenschaften aufweist. Das Einnahmeschema mit 24-tägiger Hormonanwendung, gefolgt von einem 4-tägigen hormonfreien Intervall, wurde gewählt, um die Blutungskontrolle zu verbessern, die Estradiolspiegel auf dem Niveau der frühen Follikelphase zu halten und somit einen Estrogenmangel zu vermeiden. Klinische Studien belegten die hohe kontrazeptive Wirksamkeit, ein sehr geringes Risiko für kardiovaskuläre Nebenwirkungen und ein günstiges Blutungsmuster. Aufgrund der langen Halbwertszeit von DRSP (30 – 34 Stunden), bleibt die Wirksamkeit des Präparats selbst bei einmaligem Vergessen der Pilleneinnahme erhalten. Die Aufrechterhaltung der Ovulationshemmung bei möglichem Vergessen einer Pilleneinnahme wurde in Studien mit geplanten 24-stündigen Einnahmeverzögerungen gezeigt. Nach einem Überblick über den aktuellen Stand der estrogenfreien Kontrazeption beschreibt die vorliegende Arbeit das klinische Entwicklungsprogramm des 4-mg-DRSP-Monopräparats und die daraus resultierenden Daten zur Wirksamkeit und Sicherheit dieses neuen estrogenfreien oralen hormonellen Kontrazeptivums.

Schlüsselwörter

orale Gestagene - Drospirenon - Gestagen-Monopräparate - Kontrazeption - Blutungskontrolle

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