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Completed

NCT Number: NCT01074151

The Cymbalta Pregnancy Registry

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Cymbalta Pregnancy Registry Call Center

Wilmington, North Carolina, 28405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

any exposure to duloxetine that occurred during pregnancy

Primary outcomes

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

    Time frame: maximum of 22 months

Secondary outcomes

  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

    Time frame: maximum of 22 months

  2. To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life

    Time frame: 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)

    Time frame: maximum of 22 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Syneos Health

Registry information

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2010
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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