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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-B034 | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | any exposure to duloxetine that occurred during pregnancy |
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| Measure | Description | Time Frame |
|---|---|---|
| To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta | maximum of 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | maximum of 22 months | |
| To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period
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| Name | Affiliation | Role |
|---|---|---|
| INC Research, LLC | Syneos Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cymbalta Pregnancy Registry Call Center | Wilmington | North Carolina | 28405 | United States |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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) | maximum of 22 months |
| D006571 |
| Heterocyclic Compounds |