Status:
UNKNOWN
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
Lead Sponsor:
Scott and White Hospital & Clinic
Conditions:
Menstrual Migraines
Menstrual Bleeding
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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 Menstru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01251263
Start Date
October 1 2010
End Date
October 1 2012
Last Update
December 1 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Scott and White Hospital & Clinic
Temple, Texas, United States, 76508