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

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517127-40-00

Acronym

P19.040

Enrollment

360

Registered

2024-11-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-29

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

Conditions

Migraine

Brief summary

mean change from baseline in mean monthly migraine days in a 28-day period as assessed at the 12-week timepoint (weeks 9–12).

Detailed description

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.

Interventions

DRUGVitamine E-400 complex

DRUGMicrogynon 30

DRUG0

DRUG15 mg/0

DRUG03 mg omhulde tabletten

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
mean change from baseline in mean monthly migraine days in a 28-day period as assessed at the 12-week timepoint (weeks 9–12).	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026