The Cymbalta Pregnancy Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01074151

Enrollment

144

Registered

2010-02-24

Start date

2009-07-31

Completion date

2021-07-26

Last updated

2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, pregnant, Cymbalta, Pregnancy Outcomes

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.

Interventions

DRUGduloxetine

any exposure to duloxetine that occurred during pregnancy

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026