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
Recruitment status was Recruiting
Sponsor:
Scott and White Hospital & Clinic
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
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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:
Genetics Home Reference related topics:
familial hemiplegic migraine
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
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
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 May 23, 2013