The Cymbalta Pregnancy Registry

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: INC Research; Syneos Health
• Treatments: Duloxetine Hydrochloride

Criteria

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.