The Cymbalta Pregnancy Registry
This study is currently recruiting participants.
Verified September 2012 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Collaborator:
INC Research, LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01074151
First received: February 22, 2010
Last updated: September 20, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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, LLC
Investigators
| Study Director: | INC Research, LLC | INC Research, LLC |
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: | September 20, 2012 |
| 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 May 23, 2013