The Cymbalta Pregnancy Registry

NCT01074151 | Completed DMC

• 2 other identifiers: 12938F1J-MC-B034
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; pregnant; Cymbalta; Pregnancy Outcomes

Outcome Measures

Primary Outcomes (1)

• To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta

  maximum of 22 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

duloxetine DRUG

any exposure to duloxetine that occurred during pregnancy

Pregnant patients exposed to Cymbalta

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.)

You may not qualify if:

• Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Syneos Health: collaborator

Study Sites (1)

The Cymbalta Pregnancy Registry Call Center

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• INC Research, LLC

  Syneos Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: July 1, 2009
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

US (1)