Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives. (Estradiol/MAM)

November 30, 2010 updated by: Scott and White Hospital & Clinic

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott and White Hospital & Clinic
        • Principal Investigator:
          • Patricia J Sulak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
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)
Other: Group 2
Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measure
Time Frame: 32 weeks
Compare effect of estradiol versus placebo on MAMs severity and duration.
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Patricia J Sulak, MD, Scott and White Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

November 30, 2010

First Submitted That Met QC Criteria

November 30, 2010

First Posted (Estimate)

December 1, 2010

Study Record Updates

Last Update Posted (Estimate)

December 1, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

October 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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