Trial Condition(s):

Contraception

INAS-FOCUS International Active Surveillance Study - Folate in Oral Contraceptives Utilization Study (INAS-FOCUS)

Bayer Identifier:

15346

ClinicalTrials.gov Identifier:

NCT01266408

EudraCT Number:

Not Available

Study Completed

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 surveillance
Exclusion Criteria
- Long-term users
        - Women who do not agree to participate
        - Women with a language barrier

Trial Summary

Enrollment Goal
82921
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Canada

Status
Completed
 
Locations

Investigative Site

Many locations, Russia

Status
Completed
 
Locations

Investigative Site

Many locations, Ukraine

Status
Completed
 
Locations

Investigative Site

Many locations, United States

Status
Completed
 

Trial Design