Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00905684
First received: May 18, 2009
Last updated: March 6, 2012
Last verified: March 2012
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Purpose
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
| Condition | Intervention |
|---|---|
|
Contraception |
Drug: EE30/DRSP (Yasmin, BAY86-5131) Drug: Any other OC |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)) |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling. [ Time Frame: After 3 months and at end of study after approx. 6 months. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well. [ Time Frame: After 3 months and after approx. 6 months. ] [ Designated as safety issue: No ]
- Special attention will be paid to serious adverse events and unexpected or unlisted ADRs. [ Time Frame: Over 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 5446 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: EE30/DRSP (Yasmin, BAY86-5131)
Patients under regular daily life treatment receiving Yasmin according to local drug information
|
| Group 2 |
Drug: Any other OC
Patients under regular daily life treatment receiving any other OC according to local drug information
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Criteria
Inclusion Criteria:
- Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
- Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
Exclusion Criteria:
- The contraindications and warnings of the Summary of Product Characteristics must be followed.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905684
Locations
| Albania | |
| Many locations, Albania | |
| Bahrain | |
| Many Locations, Bahrain | |
| Egypt | |
| Many locations, Egypt | |
| Hungary | |
| Many locations, Hungary | |
| Jordan | |
| Many Locations, Jordan | |
| Kenya | |
| Many locations, Kenya | |
| Kuwait | |
| Many Locations, Kuwait | |
| Lebanon | |
| Many Locations, Lebanon | |
| Macedonia, The Former Yugoslav Republic of | |
| Many locations, Macedonia, The Former Yugoslav Republic of | |
| Oman | |
| Many Locations, Oman | |
| Qatar | |
| Many Locations, Qatar | |
| Saudi Arabia | |
| Many Locations, Saudi Arabia | |
| United Arab Emirates | |
| Many locations, United Arab Emirates | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00905684 History of Changes |
| Other Study ID Numbers: | 14565, YA0801 |
| Study First Received: | May 18, 2009 |
| Last Updated: | March 6, 2012 |
| Health Authority: | Albania: Ministry of Health Department of Pharmacy Macedonia: Ministry of Health Hungary: National Institute of Pharmacy Jordan: Ethical Committee Lebanon: Institutional Review Board |
Keywords provided by Bayer:
|
Compliance Hormonal Contraception |
Additional relevant MeSH terms:
|
Contraceptive Agents Contraceptives, Oral Drospirenone and ethinyl estradiol combination Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on June 17, 2013