Status:
COMPLETED
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Lead Sponsor:
Duramed Research
Conditions:
Migraine
Eligibility:
FEMALE
18-34 years
Phase:
PHASE2
Brief Summary
This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine heada...
Eligibility Criteria
Inclusion
- Premenopausal, non-pregnant, non-lactating
- History of migraine headaches without aura for at least 6 months
- History of migraine headaches associated with menstruation
- Others as directed by FDA-approved protocol
Exclusion
- History of migraine headaches with aura or focal neurological symptoms
- Any contraindication to the use of oral contraceptives
- Others as dictated by FDA-approved protocol
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00781456
Start Date
January 1 2009
End Date
August 1 2011
Last Update
February 6 2017
Active Locations (22)
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1
Teva Investigational Site
La Mesa, California, United States, 91942
2
Duramed Investigational Site
San Diego, California, United States, 92108
3
Teva Investigational Site
San Diego, California, United States, 92123
4
Duramed Investigational Site
San Francisco, California, United States, 94109-4841