Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives. (Estradiol/MAM)
Recruitment status was: Recruiting
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.
|Menstrual Migraines Menstrual Bleeding Menstrual Spotting||Drug: Estradiol or Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.|
- Primary Outcome Measure [ Time Frame: 32 weeks ]Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.
- Secondary Outcome Measure [ Time Frame: 32 weeks ]Compare effect of estradiol versus placebo on MAMs severity and duration.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Drug: Estradiol or Placebo
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Drug: Estradiol or Placebo
Estradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251263
|Contact: Wendy M White, CCRPfirstname.lastname@example.org|
|United States, Texas|
|Scott and White Hospital & Clinic||Recruiting|
|Temple, Texas, United States, 76508|
|Principal Investigator: Patricia J Sulak, MD|
|Principal Investigator:||Patricia J Sulak, MD||Scott and White Healthcare|