Trial Outcomes & Findings for Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia (NCT NCT01319500)
NCT ID: NCT01319500
Last Updated: 2012-11-20
Results Overview
Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)
Recruitment status
COMPLETED
Target enrollment
3776 participants
Primary outcome timeframe
February 2009 - March 2009
Results posted on
2012-11-20
Participant Flow
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.
Participant milestones
| Measure |
Yasmin
Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin"
|
Other OCs
Users of oral contraceptives (OCs) except Yasmin ("Other OCs")
|
|---|---|---|
|
Overall Study
STARTED
|
1187
|
2589
|
|
Overall Study
COMPLETED
|
1187
|
2589
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia
Baseline characteristics by cohort
| Measure |
Yasmin
n=1187 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=2589 Participants
Users of OCs except Yasmin ("Other OCs")
|
Total
n=3776 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
23.8 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Age, Customized
<18 years
|
67 participants
n=5 Participants
|
62 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
Age, Customized
>=18 and <40 years
|
1097 participants
n=5 Participants
|
2398 participants
n=7 Participants
|
3495 participants
n=5 Participants
|
|
Age, Customized
>=40 years
|
11 participants
n=5 Participants
|
79 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Age, Customized
Missing
|
12 participants
n=5 Participants
|
50 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1187 Participants
n=5 Participants
|
2589 Participants
n=7 Participants
|
3776 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
1187 participants
n=5 Participants
|
2589 participants
n=7 Participants
|
3776 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: February 2009 - March 2009Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)
Outcome measures
| Measure |
Yasmin
n=1187 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=2589 Participants
Users of OCs except Yasmin ("Other OCs")
|
Gynecologists (Public Practice Only)
Gynecologists in public practice only
|
Dermatologists
All dermatologists
|
Total
All gynecologists (private and public) and dermatologists
|
|---|---|---|---|---|---|
|
OC Prescriptions by Treatment Group and Prescribing Medical Specialists
Dermatologists
|
14 Prescribing physicians
|
45 Prescribing physicians
|
—
|
—
|
—
|
|
OC Prescriptions by Treatment Group and Prescribing Medical Specialists
Gynecologists (private practice)
|
244 Prescribing physicians
|
331 Prescribing physicians
|
—
|
—
|
—
|
|
OC Prescriptions by Treatment Group and Prescribing Medical Specialists
Gynecologists (public practice)
|
929 Prescribing physicians
|
2213 Prescribing physicians
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: February 2009 - March 2009The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.
Outcome measures
| Measure |
Yasmin
n=1187 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=2589 Participants
Users of OCs except Yasmin ("Other OCs")
|
Gynecologists (Public Practice Only)
Gynecologists in public practice only
|
Dermatologists
All dermatologists
|
Total
All gynecologists (private and public) and dermatologists
|
|---|---|---|---|---|---|
|
Reasons for OC Prescriptions
Contraception only
|
53.8 percentage of participants
Interval 51.0 to 56.7
|
57.8 percentage of participants
Interval 55.9 to 59.7
|
—
|
—
|
—
|
|
Reasons for OC Prescriptions
Contraception plus non-contraceptive reasons
|
38.8 percentage of participants
Interval 36.0 to 41.6
|
29.7 percentage of participants
Interval 27.9 to 31.5
|
—
|
—
|
—
|
|
Reasons for OC Prescriptions
Non-contraceptive reasons only
|
5.2 percentage of participants
Interval 4.0 to 6.7
|
11.6 percentage of participants
Interval 10.4 to 12.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: February 2009 - March 2009Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only"
Outcome measures
| Measure |
Yasmin
n=522 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=1068 Participants
Users of OCs except Yasmin ("Other OCs")
|
Gynecologists (Public Practice Only)
Gynecologists in public practice only
|
Dermatologists
All dermatologists
|
Total
All gynecologists (private and public) and dermatologists
|
|---|---|---|---|---|---|
|
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
|
338 number of participants
|
—
|
—
|
—
|
|
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
|
246 number of participants
|
—
|
—
|
—
|
|
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
|
405 number of participants
|
—
|
—
|
—
|
|
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
|
254 number of participants
|
—
|
—
|
—
|
|
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
|
177 number of participants
|
—
|
—
|
—
|
|
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
|
130 number of participants
|
—
|
—
|
—
|
|
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
|
80 number of participants
|
—
|
—
|
—
|
|
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
|
47 number of participants
|
—
|
—
|
—
|
|
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
|
19 number of participants
|
—
|
—
|
—
|
|
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
|
10 number of participants
|
—
|
—
|
—
|
|
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
|
3 number of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: February 2009 - March 2009Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only"
Outcome measures
| Measure |
Yasmin
n=62 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=300 Participants
Users of OCs except Yasmin ("Other OCs")
|
Gynecologists (Public Practice Only)
Gynecologists in public practice only
|
Dermatologists
All dermatologists
|
Total
All gynecologists (private and public) and dermatologists
|
|---|---|---|---|---|---|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
PCOS
|
29 number of participants
|
131 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Acne
|
22 number of participants
|
97 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Painful period
|
15 number of participants
|
40 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Abnormal menstrual bleeding
|
8 number of participants
|
94 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Bleeding on demand
|
7 number of participants
|
22 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
PMS
|
3 number of participants
|
10 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Ovarian cysts
|
5 number of participants
|
17 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Uterine disease
|
4 number of participants
|
22 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
PMDD
|
0 number of participants
|
1 number of participants
|
—
|
—
|
—
|
|
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Hyperandrogenism
|
0 number of participants
|
4 number of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: February 2009 - March 2009Outcome measures
| Measure |
Yasmin
n=3717 Participants
Users of the DRSP/EE containing OC "Yasmin"
|
Other OCs
n=575 Participants
Users of OCs except Yasmin ("Other OCs")
|
Gynecologists (Public Practice Only)
n=3142 Participants
Gynecologists in public practice only
|
Dermatologists
n=59 Participants
All dermatologists
|
Total
n=3776 Participants
All gynecologists (private and public) and dermatologists
|
|---|---|---|---|---|---|
|
Reasons for OC Prescriptions by Gynecologists and Dermatologists
Contraception only
|
2130 number of participants
|
347 number of participants
|
1783 number of participants
|
5 number of participants
|
2135 number of participants
|
|
Reasons for OC Prescriptions by Gynecologists and Dermatologists
Contraceptive plus non-contraceptive reasons
|
1201 number of participants
|
178 number of participants
|
1023 number of participants
|
27 number of participants
|
1228 number of participants
|
|
Reasons for OC Prescriptions by Gynecologists and Dermatologists
Non-contraceptive reasons only
|
337 number of participants
|
32 number of participants
|
305 number of participants
|
25 number of participants
|
362 number of participants
|
Adverse Events
Yasmin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Other OCs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Juergen Dinger
Center for Epidemiology and Health Research Berlin
Phone: +49 (0)30 945 10145
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place