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Completed

NCT Number: NCT00700128

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

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.

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Key information

Conditions

Migraines Bleeding Brain Diseases Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Headache Headache Disorders Headache Disorders, Primary Hemorrhage Metrorrhagia Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Spotting Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

frovatriptan

Drug

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 names: frova

Placebo

Drug

placebo

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Scott and White Hospital & Clinic

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use During Hormone Free Intervals

Acronym: MAM

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2008
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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