Trial record 3 of 4837 for:    Pregnancy

The Cymbalta Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01074151
First received: February 22, 2010
Last updated: July 11, 2014
Last verified: July 2014
  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: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 484
Study Start Date: July 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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    866-814-6975      
Sponsors and Collaborators
Eli Lilly and Company
INC Research
Investigators
Study Director: INC Research, LLC INC Research
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01074151     History of Changes
Other Study ID Numbers: 12938, F1J-MC-B034
Study First Received: February 22, 2010
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014