The Cymbalta Pregnancy Registry

Condition(s) targeted: Pregnancy

Intervention: duloxetine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
INC Research, LLC, Study Director, Affiliation: INC Research, LLC

Overall contact:
The Cymbalta Pregnancy Registry Call Center, Phone: 1-866-814-6975, Email: pregnancyregistries@incresearch.com

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.

Official title: The Cymbalta Pregnancy Registry

Study design: Time Perspective: Prospective

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

Secondary outcome:

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

To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

The Cymbalta Pregnancy Registry Call Center, Phone: 1-866-814-6975, Email: pregnancyregistries@incresearch.com

The Cymbalta Pregnancy Registry Call Center, Wilmington, North Carolina 28405, United States; Recruiting
Phone: 866-814-6975

Starting date: July 2009
Last updated: September 20, 2012