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Pregnancy | The Cymbalta Pregnancy Registry

Pregnancy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pregnancy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:duloxetineany exposure to duloxetine that occurred during pregnancy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Recruiting

Start Date: July 2009

Completed Date: December 2020

Phase:

Type: Observational

Design:

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

Study sponsors, principal investigator, and references

Principal Investigator: INC Research, LLC

Lead Sponsor: Eli Lilly and Company

Collaborator: INC Research

More information:https://clinicaltrials.gov/show/NCT01074151

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