The Cymbalta Pregnancy Registry

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01074151
• Collaborator: Syneos Health (Other)
• Enrollment: 144
• Location: 1
• Duration (Months): 144.8
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: duloxetine

Study Design

• Study Type: Observational
• Actual Enrollment: 144 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The Cymbalta Pregnancy Registry
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 26, 2021
• Actual Study Completion Date: Jul 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Pregnant patients exposed to Cymbalta Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period	Drug: duloxetine; any exposure to duloxetine that occurred during pregnancy

Outcome Measures

Primary Outcome Measures

1. To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta [maximum of 22 months]

Secondary Outcome Measures

1. 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]

2. To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life [maximum of 22 months]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Cymbalta Pregnancy Registry Call Center	Wilmington	North Carolina	United States	28405

Sponsors and Collaborators

• Eli Lilly and Company
• Syneos Health

Investigators

• Study Director: INC Research, LLC, Syneos Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01074151
• Other Study ID Numbers: 12938; F1J-MC-B034
• First Posted: Feb 24, 2010
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by Eli Lilly and Company: Pregnancy; pregnant; Cymbalta; Pregnancy Outcomes
• Additional relevant MeSH terms: Duloxetine Hydrochloride

Study Results

No Results Posted as of Jul 18, 2022