The Cymbalta Pregnancy Registry

Pregnancy Clinical Trial

Official title:

The Cymbalta Pregnancy Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074151
• Other study ID #: 12938
• Secondary ID: F1J-MC-B034
• Status: Completed
• Start date: July 2009
• Est. completion date: July 26, 2021

Study information

• Verified date: July 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• duloxetine
any exposure to duloxetine that occurred during pregnancy

Locations

Country	Name	City	State
United States	The Cymbalta Pregnancy Registry Call Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta		maximum of 22 months
Secondary	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
Secondary	To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life		maximum of 22 months
Secondary	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