The Cymbalta Pregnancy Registry

Lilly

Status: Completed

Conditions: Pregnancy

Treatments: Drug: duloxetine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01074151

F1J-MC-B034 (Other Identifier)

12938

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

144 participants in 1 patient group

Pregnant patients exposed to Cymbalta

Description:

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

Treatment:

Drug: duloxetine