Ethinylestradiol; Levonorgestrel for Migraine|Episodic migraine|Menstrually-related migraine|Perimenopausal migraine

Inclusion criteria

• {"criterion_text":"- Trial 1: Menstrually-related migraine: Female - Age ^ 18 - Menstrually-related migraine or pure menstrual migraine - Demonstrated at least 80% compliance with eDiary during baseline period - No or stable for at least two months on prophylactic medication\n- Trial 2: Perimenopausal migraine: Female - AgeS 18 In the early menopausal transition phase (a difference of 7 days or more in length of consecutive cycles, which should occur at least twice in a period of 12 menstrual cycles) - Demonstrated at least 80% compliance with eDiary during the baseline period - No or stable for at least two months on prophylactic medication"}

Exclusion criteria

• {"criterion_text":"- \tSmoking\n- \tMigraine with aura\n- \tChronic migraine with 15 or more headache days per month/with 8 or more migraine days per month\n- \tMedication-overuse headache (ICHD-3 criteria)\n- \tWomen who are breastfeeding, pregnant, or planning to become pregnant\n- \tOral contraceptive use and not willing to undergo washout period (stop for two consecutive months)\n- \tVitamin E use at start of the study\n- \tUse of other sex hormone containing treatments\n- \tIncreased risk of VTE: history of VTE or thrombophlebitis, hereditary predisposition for VTE (APC resistance, protein C or S deficiency, antithrombin deficiency), VTE in first-degree family member at young age, long term immobilisation\n- \tIncreased risk of ATE: history of ATE, hereditary predisposition for ATE (hyperhomocysteinemia, antiphospholipid antibodies), ATE in first-degree family member at young age, diabetes mellitus, total cholesterol ≥ 6.5\n- \tOther contraindication for oral contraceptives: liver malignancy, schistosomiasis, HIV/aids, use of immunosuppressives, tuberculosis, sex-hormone-dependent malignancies (breast, endometrial or ovary carcinomas), pancreatitis, vaginal bleeding with unknown cause, other diseases that can influence vessels (malignancies, heart valve disorders, atrial fibrillation, SLE, haemolytic uremic syndrome, chronic inflammatory bowel disease, sickle cell disease)\n- \tContraindication for vitamin E: vitamin K deficiency\n- \tHypersensitivity for any of the compounds in oral contraceptive or vitamin E\n- \tSpontaneous postmenopausal status (menstrual bleedings have ceased for 12 consecutive months)\n- \tIatrogenic postmenopausal status\n- \tInability to complete the electronic diary in an accurate manner\n- \tAny serious illness that can compromise study participation"}

Primary endpoints

• {"endpoint_text":"- mean change from baseline in mean monthly migraine days in a 28-day period as assessed at the 12-week timepoint (weeks 9–12).","definition_or_measurement_approach":"Mean change from baseline in mean monthly migraine days measured over a 28-day period, assessed at the 12-week timepoint (weeks 9-12)."}

Secondary endpoints

• {"endpoint_text":"- mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12): •\tNumber of headache days •\tNumber of migraine or probable migraine attacks •\t50% responders, defined as patients who had ≥50% reduction in the number of migraine days.","definition_or_measurement_approach":"Mean change from baseline over a 28-day period assessed at 12 weeks (weeks 9-12). 50% responders defined as patients with ≥50% reduction in number of migraine days."}

Other endpoints

• {"endpoint_text":"- Secondary safety endpoints are; • Occurrence of adverse events and serious adverse events.","definition_or_measurement_approach":"Occurrence of adverse events and serious adverse events as recorded during the study per standard AE/SAE reporting (stated as secondary safety endpoints in study objectives)."}

Netherlands

Earliest CTIS Part Ii Submission Date

15-11-2024

Latest Decision Or Authorization Date

29-11-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

360

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"[10, 11, 13, 5]","organisation_type":"Hospital/Clinic/Other health care facility"}