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

Primary Purpose

Menstrual Migraines, Menstrual Bleeding, Menstrual Spotting

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estradiol or Placebo
Estradiol or Placebo
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Migraines focused on measuring headaches, migraines, breakthrough bleeding, breakthrough spotting, menstrually associated migraines, breakthrough bleeding or breakthrough spotting

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Scott and White Hospital & ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 1

Group 2

Arm Description

Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.

Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.

Outcomes

Primary Outcome Measures

Primary Outcome Measure
Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.

Secondary Outcome Measures

Secondary Outcome Measure
Compare effect of estradiol versus placebo on MAMs severity and duration.

Full Information

First Posted
November 30, 2010
Last Updated
November 30, 2010
Sponsor
Scott and White Hospital & Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01251263
Brief Title
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
Acronym
Estradiol/MAM
Official Title
Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Scott and White Hospital & Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Migraines, Menstrual Bleeding, Menstrual Spotting
Keywords
headaches, migraines, breakthrough bleeding, breakthrough spotting, menstrually associated migraines, breakthrough bleeding or breakthrough spotting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Other
Arm Description
Cyclic OC users prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Arm Title
Group 2
Arm Type
Other
Arm Description
Spontaneous ovulation group prior to initiating study OC. Estradiol or placebo given in a certain sequence depending on the randomization.
Intervention Type
Drug
Intervention Name(s)
Estradiol or Placebo
Intervention Description
Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
Intervention Type
Drug
Intervention Name(s)
Estradiol or Placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Secondary Outcome Measure
Description
Compare effect of estradiol versus placebo on MAMs severity and duration.
Time Frame
32 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy M White, CCRP
Phone
254-724-8301
Email
wewhite@swmail.sw.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J Sulak, MD
Organizational Affiliation
Scott and White Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott and White Hospital & Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia J Sulak, MD

12. IPD Sharing Statement

Learn more about this trial

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

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