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

Phase 1

• Conditions: Migraine; MedDRA version: 20.0Level: LLTClassification code 10032066Term: Other forms of migraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004096-12-NL
• Lead Sponsor: MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-18
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 360

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1.with menstrually-related migraine or pure menstrual migraine; <br>2.with perimenopausal migraine.<br>;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).

Secondary Outcome Measures

Name	Time	Method
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):<br>•Number of headache days <br>•Number of migraine or probable migraine attacks <br>•50% responders, defined as patients who had =50% reduction in the number of migraine days.<br><br>Secondary safety endpoints are:<br>•Occurrence of adverse events and serious adverse events. <br>;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).