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Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals (MAM)

Primary Purpose

Migraines, Bleeding, Spotting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
frovatriptan
frovatriptan
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 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:

  • Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in the traditional 21/7 or 24/4 manner, which means ever month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months.
  • If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days.
  • You must not want to get pregnant for 12 months.
  • Women 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 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 occurring 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 contraception.
  • Desire to become pregnant in the next 12 months.
  • Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin during their hormone free interval or the one day before the hormone free interval
  • Stroke
  • Breast Cancer
  • Blood clots in your legs, lung or anywhere else in your body
  • Diabetes mellitus
  • Heart attack
  • Liver disease
  • Lupus Erythematosus

Sites / Locations

  • Scott & White Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 2

Group1

Arm Description

Frovatriptan or placebo given in a certain sequence depending on what group that the woman are randomized to.

Group I will receive in a different sequence either frovatriptan 2.5 mg or placebo bid starting the last day of taking OC and continuing during the hormone free interval (HFI) of 4 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compare amount of bleeding and spotting within subjects in relation to duration of extended oral contraceptive pills (OCP) use for those previously using the 21/7 day regimen and those initiating OCP use directly from spontaneous cycling.

Full Information

First Posted
June 17, 2008
Last Updated
July 22, 2011
Sponsor
Scott and White Hospital & Clinic
Collaborators
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00700128
Brief Title
Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
Acronym
MAM
Official Title
Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use During Hormone Free Intervals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Scott and White Hospital & Clinic
Collaborators
Endo Pharmaceuticals

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 frovatriptan therapy on headache severity and occurrence in subjects with documented Menstrually Associated Migraines (MAM). 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 prophylactic administration of a triptan 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 triptan or placebo groups. The purpose of this research study is to examine the effects of continuous oral contraceptive pills and frovatriptan 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 look if taking frovatriptan around the time of the period will affect the headache, and how it will be affected. Frovatriptan is an FDA approved drug for migraine headaches. This study is a prospective pilot trial.The study will last approximately 35-39 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Frovatriptan or placebo given in a certain sequence depending on what group that the woman are randomized to.
Arm Title
Group1
Arm Type
Experimental
Arm Description
Group I will receive in a different sequence either frovatriptan 2.5 mg or placebo bid starting the last day of taking OC and continuing during the hormone free interval (HFI) of 4 days.
Intervention Type
Drug
Intervention Name(s)
frovatriptan
Other Intervention Name(s)
frova
Intervention Description
Frovatriptan 2.5 mg or placebo given Bid starting on the last day of OC before taking the 4 day HFI. They will take a total of 10 pills max per HFI.
Intervention Type
Drug
Intervention Name(s)
frovatriptan
Other Intervention Name(s)
frova
Intervention Description
frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Comparing baseline menstrually associated migraines (MAMs)to headache occurrence and severity after the implementation of continuous OC therapy.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Compare amount of bleeding and spotting within subjects in relation to duration of extended oral contraceptive pills (OCP) use for those previously using the 21/7 day regimen and those initiating OCP use directly from spontaneous cycling.
Time Frame
24 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: Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in the traditional 21/7 or 24/4 manner, which means ever month they have a period. If they are taking it continuously (without a period), you must be willing to take your birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months. If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days. You must not want to get pregnant for 12 months. Women 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 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 occurring 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 contraception. Desire to become pregnant in the next 12 months. Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin during their hormone free interval or the one day before the hormone free interval Stroke Breast Cancer Blood clots in your legs, lung or anywhere else in your body Diabetes mellitus Heart attack Liver disease Lupus Erythematosus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Sulak, MD
Organizational Affiliation
Scott and White Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Citations:
Citation
1. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007; 68(5):343-9. 2. Tozer BS, Boatwright EA, David PS, Verma DP, Blair JE, Mayer AP, Files JA. Prevention of migraine in women throughout the life span. Mayo Clin Proc. 2006;81(8):1086-91. 3. Macgregor EA. Menstrual migraine: a clinical review. Journal of family planning and reproductive health care, 2007. 33(1), 36-47. 4. Brandes JL. The influence of estrogen on migraine: a systematic review. JAMA, 2006; 295(15):1824-30. 5. Sulak PJ, Scow RD, Preece C, Riggs MW, Kuehl TJ. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 2000; 95:261-6. Sulak P, Willis S, Kuehl T, Coffee A, Clark J. Headaches and oral contraceptives: impact of eliminating the standard 7-day placebo interval. Headache. 2007;
Results Reference
background
Links:
URL
http://www.sw.org/web/SW/researchAndEducation/iwcontent/public/research/en_us/html/research_clinicaltrials_clinicaltrials.html#Obstetrics_Gynecology
Description
Scott & White Memorial Hospital Clinical Trials

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Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals

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