Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using … (NCT01251263) | Clinical Trial Compass
UnknownPhase 4
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
United States40 participantsStarted 2010-10
Plain-language summary
This study will examine the combined effects of a continuous oral contraceptive (OC) regimen with supplemental estradiol therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAMs). The subjects enrolling in the study will have cyclic menses either due to spontaneous ovulation or use of cyclic hormonal contraception (pill, patch, or ring). Enrolled subjects will start a continuous OC regimen following two baseline menstrual cycles. If breakthrough bleeding/spotting (BTB/BTS) occurs, the subject will institute a 4-day hormone-free interval (HFI). In an attempt to prevent/lessen the severity of headache during the HFI, subjects will be randomized to oral estradiol or placebo during this period. If no BTB/BTS occurs after 80 days of continuous pills, the subject will institute a 4-day HFI during which they will be randomized into estradiol or placebo groups.
The purpose of this research study is to examine the effects of continuous oral contraceptive pills and oral estradiol on headaches that occur around the time of your period. Many woman take continuous oral contraceptive pills (OC) and when OCs are stopped they may get headaches. This study will examine if taking estradiol around the time of the period will affect the headache, and how it will be affected.
This study is a prospective trial. A subject's participation will last approximately 32 weeks.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women may be on birth control pill (OC), patch or vaginal ring taken in the traditional 21/7 or 24/4 manner, which means that every month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 21/7 for 2 months.
* If you are not on OC's, patch or vaginal ring you must have a period every 21-40 days.
* You must not want to get pregnant for 12 months.
* Women who have headaches around the time of their period.
Exclusion Criteria:
* BMI \>38
* If you smoke and are age 35 years old or greater or if you are under 35 years old and smoke over 10 cigarettes a day.
* If you have or had an aura with your headaches. (An aura is a temporary sensation, like bright lights that come before you experience the headache)
* Headaches are not occuring during the time of your period.
* Blood Pressure \> 140/90 or you take more than a single antihypertensive medication (excluding diuretics) and are age 40 or greater.
* Contraindications to combination estrogen/progestin hormonal contraceptives.
* Desire to become pregnant in the next 12 months.
* Stroke
* Breast Cancer
* Blood clots in your legs, lung or anywhere else in your body.
* Diabetes Mellitus
* Heart Attack
* Liver Disease
* Systemic Lupus Erythematosus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves taking continuous oral contraceptives plus estrogen add-back during the hormone-free interval — how does that approach compare to what I'm currently doing or could do with standard migraine prevention medications?
2Since this is a Phase 4 trial, meaning the drugs being studied are already approved, does that change the safety profile or risks I should be aware of compared to a trial testing something brand new?
3The recruitment status for this trial is listed as 'unknown' — can you help me find out whether this study is still actively enrolling patients, and if not, are there similar studies I could look into instead?
4I experience both menstrual migraines and menstrual spotting — does having all three of those conditions listed in this trial make me a potentially stronger or weaker candidate to discuss this approach with you?
5If I were to explore this hormone-based strategy on my own outside of the trial, is estrogen add-back during the hormone-free interval something you could prescribe off-label, or would participating in a formal study be the only way to try it safely?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.