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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Scott and White Hospital & Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT01251263
First received: November 30, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Menstrual Migraines
Menstrual Bleeding
Menstrual Spotting
Drug: Estradiol or Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Comparing baseline menstrually associated migraines(MAMs) to headache occurance and severity after the implementation of continuous OC therapy.


Secondary Outcome Measures:
  • Secondary Outcome Measure [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
    Compare effect of estradiol versus placebo on MAMs severity and duration.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Group 1
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).
Group 2
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)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251263

Contacts
Contact: Wendy M White, CCRP 254-724-8301 wewhite@swmail.sw.org

Locations
United States, Texas
Scott and White Hospital & Clinic Recruiting
Temple, Texas, United States, 76508
Principal Investigator: Patricia J Sulak, MD         
Sponsors and Collaborators
Scott and White Hospital & Clinic
Investigators
Principal Investigator: Patricia J Sulak, MD Scott and White Healthcare
  More Information

No publications provided

Responsible Party: Patricia Sulak, MD/Principal Investigator, Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier: NCT01251263     History of Changes
Other Study ID Numbers: 90304
Study First Received: November 30, 2010
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Scott and White Hospital & Clinic:
headaches
migraines
breakthrough bleeding
breakthrough spotting
menstrually associated migraines
breakthrough bleeding or breakthrough spotting

Additional relevant MeSH terms:
Menstruation Disturbances
Hemorrhage
Metrorrhagia
Migraine Disorders
Premenstrual Syndrome
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Estrogens
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014