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NCT01216358 · ClinicalTrials.gov registry record
Boston Migraine and Contraception Study
A clinical trial, sponsored by Planned Parenthood League of Massachusetts.
- Completed
- Registry status
- 171
- Enrollment target
NCT01216358: Completed study, sponsored by Planned Parenthood League of Massachusetts.
NCT01216358 is a clinical trial that has completed, run by Planned Parenthood League of Massachusetts. The registered enrollment target is 171 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216358 has completed, sponsored by Planned Parenthood League of Massachusetts.
- COMPLETED
- Registry status
- 171 participants
- Enrollment target
Study Summary
The objectives of this prospective, descriptive study are to: 1. generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and 2. identify predictive factors for clinically significant changes in headache attributable to HC use. The investigators hypothesize that: 1. Most women with pre-existing migraine will have no significant change from baseline headache frequency or clinical impact attributable to HC at 3 months following initiation; a minority will report clinically significant worsening or improvement 2. The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users 3. There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.
Primary Outcome
Our primary outcome is the change in the proportion of headache days over 84 days, adjusted for baseline headache frequency
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-12 |
What the finished NCT01216358 record still lists
NCT01216358 is an observational study that tracks outcomes without assigning an intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01216358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01216358 about?
NCT01216358 is a clinical study titled "Boston Migraine and Contraception Study". The objectives of this prospective, descriptive study are to: 1. generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and 2. identify predictive factors for clinically significant changes in headache ...
What is the current status of trial NCT01216358?
This trial is currently completed. The enrollment target is 171 participants. The study started on 2010-10. Estimated completion is 2011-12.
Who is sponsoring clinical trial NCT01216358?
This trial is sponsored by Planned Parenthood League of Massachusetts, which has 13 total clinical trials registered on ClinicalTrials.gov.
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