Contraception Clinical Trial
Official title:
Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia
This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia. Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.
Large, prospective non-interventional cohort studies with active surveillance of study
participants indicate that many users of oral contraceptives use these preparations not only
for contraception but also for the treatment of hormone-dependent diseases and symptoms -
such as premenstrual dysphoric disorder, acne, endometriosis, ovarian cysts, polycystic
ovary syndrome, bleeding disorders and painful periods. In the International Active
Surveillance Study of Women Taking Oral Contraceptives (INAS) more than 30% of participants
reported that they use their OC for contra¬ception as well as for the treatment of one of
the mentioned conditions.
It is also conceivable that some women use OC not for contraception but only for one of
these hormone-dependent conditions. In most instances the exclusive use for these conditions
would constitute off-label use as only few preparations have a stand-alone approved
indication for one of these conditions.
For many countries the actual extent of off-label use of OCs for these conditions is
unknown. This applies also to Croatia. Therefore, the Croatian health authority requested a
drug utilization study to investigate current prescribing indications for Yasmin® and other
OCs in Croatia. The study details were agreed upon with the Croatian health authority.
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Time Perspective: Retrospective
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