The Cymbalta Pregnancy Registry

Completed

• Conditions: Pregnancy
• Interventions: Drug: duloxetine

• Registration Number: NCT01074151
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-24
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant patients exposed to Cymbalta	duloxetine	Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period

Primary Outcome Measures

Name	Time	Method
To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta	maximum of 22 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Cymbalta Pregnancy Registry Call Center; 🇺🇸 Wilmington, North Carolina, United States