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

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Duramed Research

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

History of migraine headaches without aura for at least 6 months

Premenopausal, non-pregnant, non-lactating

History of migraine headaches associated with menstruation

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Treatment Details

Interventions

91-day Levonorgestrel Oral Contraceptive (Oral Contraceptive)
Placebo (Placebo)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 91-day Levonorgestrel Oral ContraceptiveExperimental Treatment1 Intervention

Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.