The Cymbalta Pregnancy Registry

Eli Lilly and Company1 site in 1 country144 target enrollmentJuly 2009

ConditionsPregnancy

Interventionsduloxetine

Drugsduloxetine

Overview

Phase: Not Applicable
Intervention: duloxetine
Conditions: Pregnancy
Sponsor: Eli Lilly and Company
Enrollment: 144
Locations: 1
Primary Endpoint: To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

July 26, 2021

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

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

Intervention: duloxetine

Outcomes

Primary Outcomes

To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta

Time Frame: maximum of 22 months

Secondary Outcomes

To estimate risk of recognized spontaneous abortions, stillbirths, elective terminations, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Cymbalta and their live births during the first year of life(maximum of 22 months)
To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life(maximum of 22 months)
To compare the risk of major congenital anomalies among pregnancies exposed to Cymbalta to an appropriate comparator(s) such as the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP)(maximum of 22 months)