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Study on Ethinylestradiol/Levonorgestrel and Vitamin E for Treating Menstrual and Perimenopausal Migraines in Women

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two treatments for women experiencing migraines related to their menstrual cycle or the perimenopausal phase. The diseases being studied are menstrually-related migraine and perimenopausal migraine. The trial will compare the use of a medication called ethinylestradiol/levonorgestrel, which is a combination of hormones often used in birth control, with vitamin E, a nutrient that acts as an antioxidant. The purpose of the study is to evaluate how these treatments affect the frequency of migraine days over a period of time.

Participants in the study will be asked to take either the hormone combination or vitamin E daily. The study will last for a total of 12 weeks, during which the number of migraine days will be monitored and recorded. This will help researchers understand if there is a significant change in the frequency of migraines when using these treatments. The study aims to provide insights into whether continuous daily use of these treatments can reduce the number of migraine days experienced by women with these specific types of migraines.

Throughout the study, participants will be monitored to assess the effectiveness of the treatments. The main focus will be on the change in the number of migraine days over a 28-day period, particularly during the last four weeks of the study. This information will help determine if either treatment is beneficial in managing migraines associated with menstrual cycles or the perimenopausal phase. The study will also look at other factors, such as the number of headache days and the number of migraine attacks, to provide a comprehensive understanding of the treatments' effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the clinical trial, participants will be assigned to one of two groups. One group will receive ethinylestradiol/levonorgestrel and the other group will receive vitamin E.

  2. Step 2

    Medication administration

    Participants in the first group will take a coated tablet containing ethinylestradiol/levonorgestrel at a dosage of 30/150 micrograms per day. This medication is taken orally once daily.

    Participants in the second group will take a soft capsule containing vitamin E at a dosage of 400 IU per day. This medication is also taken orally once daily.

  3. Step 3

    Trial duration

    The trial will last for a total of 12 weeks. During this period, participants will continue to take their assigned medication daily.

  4. Step 4

    Tracking and assessment

    Participants are required to maintain an eDiary to record their migraine occurrences and any other relevant symptoms. This helps in assessing the effectiveness of the treatment.

    Compliance with the eDiary is important, with at least 80% compliance expected during the baseline period.

  5. Step 5

    Evaluation

    At the end of the 12-week period, the primary measure of success will be the mean change in monthly migraine days compared to the baseline.

    Secondary measures include the number of headache days, the number of migraine attacks, and the percentage of participants experiencing a 50% reduction in migraine days.

Who can join the trial?

6 criteria

  • Must be a female participant.
  • Must be 18 years or older.
  • For Trial 1: Must have menstrually-related migraine or pure menstrual migraine. This means migraines that are linked to the menstrual cycle.
  • For Trial 2: Must have perimenopausal migraine. This refers to migraines occurring during the transition phase to menopause, which is marked by changes in menstrual cycle length.
  • Must have shown at least 80% compliance with using an electronic diary (eDiary) during the baseline period. This means regularly recording information as required by the study.
  • Must not be on any preventive migraine medication, or if on such medication, it must be stable for at least two months.

Who cannot join the trial?

10 criteria

  • Participants must not have any other serious health conditions that could interfere with the study.
  • Participants should not be pregnant or planning to become pregnant during the study.
  • Participants must not be breastfeeding.
  • Participants should not have a history of blood clots or any condition that increases the risk of blood clots.
  • Participants must not have uncontrolled high blood pressure.
  • Participants should not have liver disease or any condition affecting liver function.
  • Participants must not have a history of breast cancer or any other hormone-sensitive cancer.
  • Participants should not be using any other hormonal treatments that could interfere with the study.
  • Participants must not have any known allergies to the study medications.
  • Participants should not have a history of severe migraines that are not related to their menstrual cycle.
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Investigated drugs

  • Ethinylestradiol/Levonorgestrel

    is a combination of two hormones commonly used in birth control pills. In this trial, it is being tested to see if it can help reduce the number of migraine days in women who experience migraines related to their menstrual cycle or during perimenopause. The idea is that by taking these hormones continuously, it might stabilize hormone levels and potentially lessen the frequency or severity of migraines.

  • Vitamin E

    is a nutrient that acts as an antioxidant in the body. In this trial, it is being used to see if it can help reduce migraines in women. The researchers are interested in finding out if taking Vitamin E daily can decrease the number of migraine days for women who have migraines related to their menstrual cycle or during perimenopause. The hope is that Vitamin E might have a beneficial effect on migraines due to its antioxidant properties.

What is already known about the treatment

  • Ethinylestradiol/Levonorgestrel

    This medication is taken orally in the form of a daily pill. It is currently being studied in clinical trials for its effects on migraines related to menstrual cycles and menopause. The main use of this medication is to help reduce the number of migraine days in women experiencing these types of migraines. It works by regulating hormones in the body, which can help stabilize the fluctuations that may trigger migraines. Ethinylestradiol/Levonorgestrel is classified as a combination hormonal contraceptive, which is commonly used for birth control but is being explored for its potential benefits in migraine management.

  • Vitamin E

    This medication is administered orally as a daily supplement in the form of a capsule. It is being investigated in clinical trials for its potential to alleviate migraines associated with menstrual cycles and menopause. The primary therapeutic use of Vitamin E in this context is to reduce the frequency of migraine days. It is believed to work by providing antioxidant effects that may help protect cells from damage and reduce inflammation, which can contribute to migraine symptoms. Vitamin E is classified as a dietary supplement and antioxidant.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. It can be accompanied by nausea, vomiting, and sensitivity to light and sound. The progression of a migraine attack typically involves four stages: prodrome, aura, headache, and postdrome, although not everyone experiences all stages. The prodrome phase can start a day or two before the headache, with symptoms like mood changes and food cravings. The aura phase may involve visual disturbances or other sensory changes. The headache phase can last from a few hours to several days, followed by the postdrome phase, where individuals may feel drained or confused.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517127-40-00Protocol codeP19.040Estimated enrolment360 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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