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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: 91-day Levonorgestrel Oral Contraceptive

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781456

DR-105-201

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups, including a placebo group

91-day Levonorgestrel Oral Contraceptive

Experimental group

Description:

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.

Treatment:

Drug: 91-day Levonorgestrel Oral Contraceptive

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo