The Cymbalta Pregnancy Registry - Full Text View

Sponsor:	Eli Lilly and Company
Collaborator:	Kendle International
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01074151

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:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074151

Contacts

Contact: The Cymbalta Pregnancy Registry Call Center

1-866-814-6975

registries@kendle.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

Kendle International

Investigators

Study Director:

Kendle International

Kendle

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT01074151 History of Changes
Other Study ID Numbers:	12938, F1J-MC-B034
Study First Received:	February 22, 2010
Last Updated:	March 4, 2011
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012