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Trial record 8 of 42 for:    FROVATRIPTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700128
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : July 25, 2011
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
Scott and White Hospital & Clinic

Tracking Information
First Submitted Date  ICMJE June 17, 2008
First Posted Date  ICMJE June 18, 2008
Last Update Posted Date July 25, 2011
Study Start Date  ICMJE June 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
Comparing baseline menstrually associated migraines (MAMs)to headache occurrence and severity after the implementation of continuous OC therapy. [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals
Official Title  ICMJE Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use During Hormone Free Intervals
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraines
  • Bleeding
  • Spotting
Intervention  ICMJE
  • Drug: frovatriptan
    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.
    Other Name: frova
  • Drug: frovatriptan
    frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.
    Other Name: frova
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: Group 2
    Frovatriptan or placebo given in a certain sequence depending on what group that the woman are randomized to.
    Interventions:
    • Drug: frovatriptan
    • Drug: placebo
  • Experimental: Group1
    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.
    Interventions:
    • Drug: frovatriptan
    • Drug: placebo
Publications * 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;

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2011)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2008)
40
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00700128
Other Study ID Numbers  ICMJE 060714
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Sulak, MD prinicipal investigator, Scott and White Hospital
Study Sponsor  ICMJE Scott and White Hospital & Clinic
Collaborators  ICMJE Endo Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Patricia Sulak, MD Scott and White Hospital
PRS Account Scott and White Hospital & Clinic
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP