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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

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.

Condition or disease
Contraception

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.


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Study Type : Observational
Actual Enrollment : 3776 participants
Time Perspective: Retrospective
Official Title: Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia
Study Start Date : February 2009

Group/Cohort
Yasmin
Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin"
Other OCs
Users of OCs except Yasmin ("Other OCs")



Primary Outcome Measures :
  1. OC Prescriptions by Treatment Group and Prescribing Medical Specialists [ Time Frame: February 2009 - March 2009 ]
    Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)

  2. Reasons for OC Prescriptions [ Time Frame: February 2009 - March 2009 ]
    The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.

  3. Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons [ Time Frame: February 2009 - March 2009 ]
    Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only"

  4. Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only) [ Time Frame: February 2009 - March 2009 ]
    Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only"

  5. Reasons for OC Prescriptions by Gynecologists and Dermatologists [ Time Frame: February 2009 - March 2009 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319500


Locations
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Germany
Center for Epidemiology and Health Research Berlin
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Investigators
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Principal Investigator: Juergen C Dinger, MD, PhD Berlin Center for Epidemiology and Health Research

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Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01319500     History of Changes
Other Study ID Numbers: ZEG 2009_02
First Posted: March 21, 2011    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: November 20, 2012
Last Verified: October 2012

Keywords provided by Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany:
Drug Utilization
Oral Contraceptives

Additional relevant MeSH terms:
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Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs