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The Cymbalta Pregnancy Registry

This study is currently recruiting participants.
Verified June 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074151
First Posted: February 24, 2010
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
INC Research
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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 Intervention
Pregnancy Drug: duloxetine

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: The Cymbalta Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta [ Time Frame: maximum of 22 months ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 484
Study Start Date: July 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074151


Contacts
Contact: The Cymbalta Pregnancy Registry Call Center 1-866-814-6975 pregnancyregistries@incresearch.com

Locations
United States, North Carolina
The Cymbalta Pregnancy Registry Call Center Recruiting
Wilmington, North Carolina, United States, 28405
Contact    910-509-4700      
Principal Investigator: Vikki Brown         
Sponsors and Collaborators
Eli Lilly and Company
INC Research
Investigators
Study Director: INC Research, LLC INC Research
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01074151     History of Changes
Other Study ID Numbers: 12938
F1J-MC-B034 ( Other Identifier: Eli Lilly and Company )
First Submitted: February 22, 2010
First Posted: February 24, 2010
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Eli Lilly and Company:
Pregnancy
pregnant
Cymbalta
Pregnancy Outcomes

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents


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