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Group 1 for Menstrual Migraine (Estradiol/MAM Trial)

Phase 4
Waitlist Available
Led By Patricia J Sulak, MD
Research Sponsored by Scott and White Hospital & Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights

Estradiol/MAM Trial 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.

Eligible Conditions
  • Menstrual Migraine
  • Menstruation
  • Menstrual Spotting

Estradiol/MAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure
Secondary outcome measures
Measure

Estradiol/MAM Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Group II: Group 1Experimental Treatment1 Intervention
Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.

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Who is running the clinical trial?

Scott and White Hospital & ClinicLead Sponsor
22 Previous Clinical Trials
32,444 Total Patients Enrolled
Patricia J Sulak, MDPrincipal InvestigatorScott and White Healthcare
1 Previous Clinical Trials
80 Total Patients Enrolled

Frequently Asked Questions

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~3 spots leftby Apr 2025