A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Female

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 headaches.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duramed Research
• Treatments: Contraceptive Agents; Contraceptives, Oral; Levonorgestrel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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