Conditions: Migraine
Keywords: Migraine headache menstrual oral contraceptive Menstrually-Related Migraine Headache
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

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 headaches.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: Placebo
Intervention descriptions: intervention 1: 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 2: 1 tablet daily to match experimental arm

Protocol document: