PregnancyNCT01074151
The Cymbalta Pregnancy Registry
An observational study of Pregnancy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- duloxetine
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.)
Who cannot join
- Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cymbalta Pregnancy Registry Call Center
Wilmington, North Carolina, 28405
About this study
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.
- Conditions
- Pregnancy
- Being tested
- duloxetine
- Keywords
- Pregnancy, pregnant, Cymbalta, Pregnancy Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
any exposure to duloxetine that occurred during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta
Measured: maximum of 22 months
Secondary outcomes (3)
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
Measured: maximum of 22 months
To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life
Measured: 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)
Measured: maximum of 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJul 2009
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- INC Research, LLC, Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074151
- Sponsor's protocol ID
- 12938
- Other IDs
- F1J-MC-B034
- Status last verified
- Jul 2022
- First submitted
- 22 Feb 2010
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cymbalta Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01074151
- Acronym / sponsor ID
- 12938
- Conditions
- Pregnancy
- Keywords
- Pregnancy, pregnant, Cymbalta, Pregnancy Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Jul 2009
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients exposed to Cymbalta | – | Drug: duloxetinePregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetineany exposure to duloxetine that occurred during pregnancy | Drug | Pregnant patients exposed to Cymbalta |
Primary outcome
To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta
Time frame: maximum of 22 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
INC Research, LLC study director
Syneos Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta (time frame: maximum of 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.