Trial Condition(s):
Contraception
INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study (INAS-FOCUS)
Bayer Identifier:
15346
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study compares the risks of short- and long-term use of contraceptives containing drospirenone (DRSP) or dienogest (DNG)/ ethinylestradiol (EE) plus levomefolate calcium (metafolin) with the risks of short- and long-term use of other established oral contraceptives (OCs).
Inclusion Criteria
- Women starting OC use ("starters")
- Women switching OC use without a pill intake break ("switchers")
- Women restarting OC use after a pill intake break ("restarters")
- Women willing to participate in the active surveillanceExclusion Criteria
- Long-term users
- Women who do not agree to participate
- Women with a language barrierTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, Canada | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many locations, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Absolute risk of venous thromboembolic eventsTimeframe: Up to 6 years
- Absolute risk of acute myocardial infarctionTimeframe: Up to 6 years
- Absolute risk of cerebrovascular accidentsTimeframe: Up to 6 years
Secondary Outcome
- Colorectal cancerTimeframe: Up to 6 years
- Other cancer entitiesTimeframe: Up to 6 years
Additional Information
Not Available
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