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| Tracking Information | |||||||||
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| First Received Date † | June 8, 2006 | ||||||||
| Last Updated Date | December 22, 2008 | ||||||||
| Start Date † | August 2005 | ||||||||
| Current Primary Outcome Measures † |
Thromboembolic events [ Time Frame: Within 48 months ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00335257 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) | ||||||||
| Official Title † | International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC) | ||||||||
| Brief Summary | The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations. |
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| Detailed Description | Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. The study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations. This is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in May 2008 based on the launch status of the 24-day regimen. New users of an OC (starters or switchers) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Condition † | Contraception | ||||||||
| Intervention † | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 80000 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00335257 | ||||||||
| Responsible Party | Juergen C Dinger, MD, PhD, Principal Investiator, Center for Epidemiology and Health Research, Germany | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Center for Epidemiology and Health Research, Germany | ||||||||
| Collaborators †† | Bayer Schering Pharmaceutical | ||||||||
| Investigators † |
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| Information Provided By | Center for Epidemiology and Health Research, Germany | ||||||||
| Verification Date | December 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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