Clinical trial NCT01319500: Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia
Official title: Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Drug Utilization
Oral Contraceptives
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 3776
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Overall, a representative sample of 100 gynecologists and 31 dermatologists are asked to contribute OC prescribing data to this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* women with an OC prescription during the timeframe (Feb-March 2011)

Primary outcomes:
measure: OC Prescriptions by Treatment Group and Prescribing Medical Specialists
timeFrame: February 2009 - March 2009
measure: Reasons for OC Prescriptions
timeFrame: February 2009 - March 2009
measure: Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons
timeFrame: February 2009 - March 2009
measure: Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
timeFrame: February 2009 - March 2009
measure: Reasons for OC Prescriptions by Gynecologists and Dermatologists
timeFrame: February 2009 - March 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research Berlin
Study officials:
affiliation: Berlin Center for Epidemiology and Health Research
name: Juergen C Dinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: