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NCT00317564 · ClinicalTrials.gov registry record
Betaseron Pregnancy Registry
A clinical trial, sponsored by Syneos Health.
- Completed
- Registry status
- 113
- Enrollment target
NCT00317564 is a clinical trial that has completed, run by Syneos Health. The registered enrollment target is 113 participants.
The verdict
NCT00317564 has completed, sponsored by Syneos Health.
- COMPLETED
- Registry status
- 113 participants
- Enrollment target
Study Summary
This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval \& Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00317564
The ClinicalTrials.gov registry entry for NCT00317564 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syneos Health, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00317564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00317564 about?
NCT00317564 is a clinical study titled "Betaseron Pregnancy Registry". This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an inc...
What is the current status of trial NCT00317564?
This trial is currently completed. The enrollment target is 113 participants. The study started on 2006-04. Estimated completion is 2012-06.
Who is sponsoring clinical trial NCT00317564?
This trial is sponsored by Syneos Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
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