The Cymbalta Pregnancy Registry
Purpose
The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.
Condition
- Pregnancy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Sufficient evidence (e.g., date or gestational age) to confirm that Cymbalta exposure occurred during pregnancy - Sufficient data to establish in which trimester of pregnancy the exposure to Cymbalta first occurred (i.e., first, second or third trimester) - Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the Registry) - Date the pregnancy exposure is reported to the Registry - Source of the report (Health Care Professional or pregnant patient) - Full contact information for the reporter and Health Care Professional willing and able to provide accurate pregnancy-related information (name, address, phone number, etc.)
Exclusion Criteria
- Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Pregnant patients exposed to Cymbalta | Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period |
|
Recruiting Locations
More Details
- NCT ID
- NCT01074151
- Status
- Completed
- Sponsor
- Eli Lilly and Company