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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yasmin | Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin" | ||
| Other OCs | Users of OCs except Yasmin ("Other OCs") |
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| Measure | Description | Time Frame |
|---|---|---|
| OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists) | February 2009 - March 2009 |
| Reasons for OC Prescriptions | The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only. | February 2009 - March 2009 |
| Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons | Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only" | February 2009 - March 2009 |
| Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only" | February 2009 - March 2009 |
| Reasons for OC Prescriptions by Gynecologists and Dermatologists | February 2009 - March 2009 |
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Inclusion Criteria:
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Overall, a representative sample of 100 gynecologists and 31 dermatologists are asked to contribute OC prescribing data to this study.
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| Name | Affiliation | Role |
|---|---|---|
| Juergen C Dinger, MD, PhD | Berlin Center for Epidemiology and Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Epidemiology and Health Research Berlin | Berlin | 10115 | Germany |
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A representative sample of 100 Croatian gynecologists and 31 dermatologists were asked to fill in a questionnaire for each of their oral contraceptive (OC) prescriptions from February 16, 2009 to March 15, 2009. Questions included the name of the OC, date and reason for prescription, and the reproductive status and demographics of the patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yasmin | Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin" |
| FG001 | Other OCs | Users of oral contraceptives (OCs) except Yasmin ("Other OCs") |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yasmin | Users of the DRSP/EE containing OC "Yasmin" |
| BG001 | Other OCs | Users of OCs except Yasmin ("Other OCs") |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists) | Posted | Number | Prescribing physicians | February 2009 - March 2009 |
|
|
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Adverse event data were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yasmin | Users of the DRSP/EE containing OC "Yasmin" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Juergen Dinger | Center for Epidemiology and Health Research Berlin | +49 (0)30 945 10145 | dinger@zeg-berlin.de |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Reasons for OC Prescriptions | The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only. | Posted | Number | 95% Confidence Interval | percentage of participants | February 2009 - March 2009 |
|
|
|
| Primary | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons | Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only" | Posted | Number | number of participants | February 2009 - March 2009 |
|
|
|
| Primary | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only" | Posted | Number | number of participants | February 2009 - March 2009 |
|
|
|
| Primary | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Posted | Number | number of participants | February 2009 - March 2009 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Other OCs | Users of OCs except Yasmin ("Other OCs") | 0 | 0 | 0 | 0 |
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| Non-contraceptive reasons only |
|
| PCOS |
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| Abnormal menstrual bleeding |
|
| Bleeding on demand |
|
| PMS |
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| Ovarian cysts |
|
| Uterine disease |
|
| PMDD |
|
| Hyperandrogenism |
|
| Other |
|
| Painful period |
|
| Abnormal menstrual bleeding |
|
| Bleeding on demand |
|
| PMS |
|
| Ovarian cysts |
|
| Uterine disease |
|
| PMDD |
|
| Hyperandrogenism |
|
| Contraceptive plus non-contraceptive reasons |
|
| Non-contraceptive reasons only |
|