Study of the efficacy of combined oral contraceptives compared with vitamin E in women with migraine

Open-label randomized controlled trial for the effects of continuous ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in the treatment of menstrually-related migraine and migraine during perimenopause - WHAT! - RCT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004096-12-NL

Enrollment

360

Registered

2019-04-18

Start date

2019-06-03

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine MedDRA version: 20.0 Level: LLT Classification code 10032066 Term: Other forms of migraine System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Microgynon30 Pharmaceutical Form: Tablet INN or Proposed INN: ETHINYLESTRADIOL CAS Number: 57-63-6 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30- I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - women with menstrually-related migraine or pure menstrual migraine. - women with migraine in the menopausal transition phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: smoking, migraine with aura, breastfeeding/pregnancy, contraindications for the use of microgynon30/vitamin E

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in women: 1.with menstrually-related migraine or pure menstrual migraine; 2.with perimenopausal migraine. ;Secondary Objective: Not applicable;Primary end point(s): Number of monthly migraine days;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is mean change from baseline in mean monthly migraine days in a 28-day period as assessed at the 12-week timepoint (weeks 9–12).	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of continuous daily use of ethinylestradiol/levonorgestrel (30/150 µg/day) compared with vitamin E (400 IU/day) in women: 1.with menstrually-related migraine or pure menstrual migraine; 2.with perimenopausal migraine. ;Secondary Objective: Not applicable;Primary end point(s): Number of monthly migraine days;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is mean change from baseline in mean monthly migraine days in a 28-day period as assessed at the 12-week timepoint (weeks 9–12).

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints are defined as the mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12): • Number of headache days • Number of migraine or probable migraine attacks • 50% responders, defined as patients who had =50% reduction in the number of migraine days. Secondary safety endpoints are: • Occurrence of adverse events and serious adverse events. ;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints are defined as the mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12).	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints are defined as the mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12): • Number of headache days • Number of migraine or probable migraine attacks • 50% responders, defined as patients who had =50% reduction in the number of migraine days. Secondary safety endpoints are: • Occurrence of adverse events and serious adverse events. ;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints are defined as the mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12).

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Countries

Netherlands

Contacts

Public ContactG.M. Terwindt

LUMC

G.M.Terwindt@lumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026