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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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91-day Levonorgestrel Oral Contraceptive

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 Type EXPERIMENTAL

91-day Levonorgestrel Oral Contraceptive

Intervention Type DRUG

91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet daily to match experimental arm

Interventions

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91-day Levonorgestrel Oral Contraceptive

91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.

Intervention Type DRUG

Placebo

1 tablet daily to match experimental arm

Intervention Type DRUG

Other Intervention Names

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Seasonique DR-105

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No