Contraception
Conditions
Keywords
Drug Utilization, Oral Contraceptives
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.
Interventions
None listed
Sponsors
Center for Epidemiology and Health Research, Germany
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* women with an OC prescription during the timeframe (Feb-March 2011)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OC Prescriptions by Treatment Group and Prescribing Medical Specialists | February 2009 - March 2009 | Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists) |
| Reasons for OC Prescriptions | February 2009 - March 2009 | The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only. |
| Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | February 2009 - March 2009 | Non-contraceptive reasons for OC prescriptions (including both categories: contraception plus non-contraceptive reasons and non-contraceptive reasons only |
| Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | February 2009 - March 2009 | Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category non-contraceptive reasons only |
| Reasons for OC Prescriptions by Gynecologists and Dermatologists | February 2009 - March 2009 | — |
Countries
Germany
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Yasmin Users of the DRSP/EE containing OC Yasmin | 1,187 |
| Other OCs Users of OCs except Yasmin (Other OCs) | 2,589 |
| Total | 3,776 |
Baseline characteristics
| Characteristic | Yasmin | Other OCs | Total |
|---|---|---|---|
| Age Continuous | 23.8 years STANDARD_DEVIATION 5 | 26.5 years STANDARD_DEVIATION 6.3 | 25.7 years STANDARD_DEVIATION 6 |
| Age, Customized >=18 and <40 years | 1097 participants | 2398 participants | 3495 participants |
| Age, Customized <18 years | 67 participants | 62 participants | 129 participants |
| Age, Customized >=40 years | 11 participants | 79 participants | 90 participants |
| Age, Customized Missing | 12 participants | 50 participants | 62 participants |
| Region of Enrollment Croatia | 1187 participants | 2589 participants | 3776 participants |
| Sex: Female, Male Female | 1187 Participants | 2589 Participants | 3776 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: February 2009 - March 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Abnormal menstrual bleeding | 100 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Ovarian cysts | 34 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PCOS | 199 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Uterine disease | 33 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Bleeding on demand | 63 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PMDD | 4 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Painful period | 212 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Hyperandrogenism | 3 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PMS | 59 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Other | 0 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Acne | 226 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Other | 3 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Acne | 338 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Painful period | 246 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PCOS | 405 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Abnormal menstrual bleeding | 254 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Bleeding on demand | 177 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PMS | 130 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Ovarian cysts | 80 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Uterine disease | 47 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | PMDD | 19 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons | Hyperandrogenism | 10 number of participants |
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
Time frame: February 2009 - March 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PCOS | 29 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Acne | 22 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Painful period | 15 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Abnormal menstrual bleeding | 8 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Bleeding on demand | 7 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PMS | 3 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Ovarian cysts | 5 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Uterine disease | 4 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PMDD | 0 number of participants |
| Yasmin | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Hyperandrogenism | 0 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Uterine disease | 22 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PCOS | 131 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PMS | 10 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Acne | 97 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Hyperandrogenism | 4 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Painful period | 40 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Ovarian cysts | 17 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Abnormal menstrual bleeding | 94 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | PMDD | 1 number of participants |
| Other OCs | Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) | Bleeding on demand | 22 number of participants |
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)
Time frame: February 2009 - March 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yasmin | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Gynecologists (private practice) | 244 Prescribing physicians |
| Yasmin | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Gynecologists (public practice) | 929 Prescribing physicians |
| Yasmin | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Dermatologists | 14 Prescribing physicians |
| Other OCs | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Gynecologists (private practice) | 331 Prescribing physicians |
| Other OCs | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Gynecologists (public practice) | 2213 Prescribing physicians |
| Other OCs | OC Prescriptions by Treatment Group and Prescribing Medical Specialists | Dermatologists | 45 Prescribing physicians |
Primary
Reasons for OC Prescriptions
The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.
Time frame: February 2009 - March 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yasmin | Reasons for OC Prescriptions | Contraception only | 53.8 percentage of participants |
| Yasmin | Reasons for OC Prescriptions | Contraception plus non-contraceptive reasons | 38.8 percentage of participants |
| Yasmin | Reasons for OC Prescriptions | Non-contraceptive reasons only | 5.2 percentage of participants |
| Other OCs | Reasons for OC Prescriptions | Contraception only | 57.8 percentage of participants |
| Other OCs | Reasons for OC Prescriptions | Contraception plus non-contraceptive reasons | 29.7 percentage of participants |
| Other OCs | Reasons for OC Prescriptions | Non-contraceptive reasons only | 11.6 percentage of participants |
Primary
Reasons for OC Prescriptions by Gynecologists and Dermatologists
Time frame: February 2009 - March 2009
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Yasmin | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraception only | 2130 number of participants |
| Yasmin | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Non-contraceptive reasons only | 337 number of participants |
| Yasmin | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraceptive plus non-contraceptive reasons | 1201 number of participants |
| Other OCs | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraceptive plus non-contraceptive reasons | 178 number of participants |
| Other OCs | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraception only | 347 number of participants |
| Other OCs | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Non-contraceptive reasons only | 32 number of participants |
| Gynecologists (Public Practice Only) | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraceptive plus non-contraceptive reasons | 1023 number of participants |
| Gynecologists (Public Practice Only) | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraception only | 1783 number of participants |
| Gynecologists (Public Practice Only) | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Non-contraceptive reasons only | 305 number of participants |
| Dermatologists | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraception only | 5 number of participants |
| Dermatologists | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Non-contraceptive reasons only | 25 number of participants |
| Dermatologists | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraceptive plus non-contraceptive reasons | 27 number of participants |
| Total | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraceptive plus non-contraceptive reasons | 1228 number of participants |
| Total | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Contraception only | 2135 number of participants |
| Total | Reasons for OC Prescriptions by Gynecologists and Dermatologists | Non-contraceptive reasons only | 362 number of participants |