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Trial record 76 of 100 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND ethinylestradiol

Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia

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ClinicalTrials.gov Identifier: NCT01319500
Recruitment Status : Completed
First Posted : March 21, 2011
Results First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany

Study Type Observational
Study Design Time Perspective: Retrospective
Condition Contraception
Enrollment 3776
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.
Pre-assignment Details  
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin" Users of oral contraceptives (OCs) except Yasmin ("Other OCs")
Period Title: Overall Study
Started 1187 2589
Completed 1187 2589
Not Completed 0 0
Arm/Group Title Yasmin Other OCs Total
Hide Arm/Group Description Users of the DRSP/EE containing OC "Yasmin" Users of OCs except Yasmin ("Other OCs") Total of all reporting groups
Overall Number of Baseline Participants 1187 2589 3776
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1187 participants 2589 participants 3776 participants
23.8  (5.0) 26.5  (6.3) 25.7  (6.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1187 participants 2589 participants 3776 participants
<18 years 67 62 129
>=18 and <40 years 1097 2398 3495
>=40 years 11 79 90
Missing 12 50 62
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1187 participants 2589 participants 3776 participants
Female
1187
 100.0%
2589
 100.0%
3776
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Croatia Number Analyzed 1187 participants 2589 participants 3776 participants
1187 2589 3776
1.Primary Outcome
Title OC Prescriptions by Treatment Group and Prescribing Medical Specialists
Hide Description Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)
Time Frame February 2009 - March 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description:
Users of the DRSP/EE containing OC "Yasmin"
Users of OCs except Yasmin ("Other OCs")
Overall Number of Participants Analyzed 1187 2589
Measure Type: Number
Unit of Measure: Prescribing physicians
Gynecologists (private practice) 244 331
Gynecologists (public practice) 929 2213
Dermatologists 14 45
2.Primary Outcome
Title Reasons for OC Prescriptions
Hide Description The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.
Time Frame February 2009 - March 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description:
Users of the DRSP/EE containing OC "Yasmin"
Users of OCs except Yasmin ("Other OCs")
Overall Number of Participants Analyzed 1187 2589
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Contraception only
53.8
(51.0 to 56.7)
57.8
(55.9 to 59.7)
Contraception plus non-contraceptive reasons
38.8
(36.0 to 41.6)
29.7
(27.9 to 31.5)
Non-contraceptive reasons only
5.2
(4.0 to 6.7)
11.6
(10.4 to 12.9)
3.Primary Outcome
Title Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description:
Users of the DRSP/EE containing OC "Yasmin"
Users of OCs except Yasmin ("Other OCs")
Overall Number of Participants Analyzed 522 1068
Measure Type: Number
Unit of Measure: number of participants
Acne 226 338
Painful period 212 246
PCOS 199 405
Abnormal menstrual bleeding 100 254
Bleeding on demand 63 177
PMS 59 130
Ovarian cysts 34 80
Uterine disease 33 47
PMDD 4 19
Hyperandrogenism 3 10
Other 0 3
4.Primary Outcome
Title Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)
Hide Description Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only"
Time Frame February 2009 - March 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description:
Users of the DRSP/EE containing OC "Yasmin"
Users of OCs except Yasmin ("Other OCs")
Overall Number of Participants Analyzed 62 300
Measure Type: Number
Unit of Measure: number of participants
PCOS 29 131
Acne 22 97
Painful period 15 40
Abnormal menstrual bleeding 8 94
Bleeding on demand 7 22
PMS 3 10
Ovarian cysts 5 17
Uterine disease 4 22
PMDD 0 1
Hyperandrogenism 0 4
5.Primary Outcome
Title Reasons for OC Prescriptions by Gynecologists and Dermatologists
Hide Description [Not Specified]
Time Frame February 2009 - March 2009
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gynecologists (All) Gynecologists (Private Practice Only) Gynecologists (Public Practice Only) Dermatologists Total
Hide Arm/Group Description:
All gynecologists (private and public)
Gynecologists in private practice only
Gynecologists in public practice only
All dermatologists
All gynecologists (private and public) and dermatologists
Overall Number of Participants Analyzed 3717 575 3142 59 3776
Measure Type: Number
Unit of Measure: number of participants
Contraception only 2130 347 1783 5 2135
Contraceptive plus non-contraceptive reasons 1201 178 1023 27 1228
Non-contraceptive reasons only 337 32 305 25 362
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data were not collected.
 
Arm/Group Title Yasmin Other OCs
Hide Arm/Group Description Users of the DRSP/EE containing OC "Yasmin" Users of OCs except Yasmin ("Other OCs")
All-Cause Mortality
Yasmin Other OCs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Yasmin Other OCs
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Yasmin Other OCs
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Juergen Dinger
Organization: Center for Epidemiology and Health Research Berlin
Phone: +49 (0)30 945 10145
Responsible Party: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01319500     History of Changes
Other Study ID Numbers: ZEG 2009_02
First Submitted: March 18, 2011
First Posted: March 21, 2011
Results First Submitted: August 15, 2012
Results First Posted: November 20, 2012
Last Update Posted: November 20, 2012