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MigrainesMAMNCT00700128

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

A study testing frovatriptan in people with Migraines and Bleeding, run by Scott and White Hospital & Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Migraines, Bleeding, Spotting
What is being tested?
frovatriptan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Jun 2008to Jan 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

Other trials in United States

About this study

Official title: Prevention of Menstrual Migraines: Effects of Continuous Oral Contraceptives to Combination With Prophylactic Frovatriptan Use 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.

Being tested
frovatriptan, placebo
Keywords
headaches, migraines, breakthrough bleeding, breakthrough spotting, menstrually associated migraines, breakthrough bleeding or breakthrough spotting
Medical subject headings
Migraine Disorders, Hemorrhage, Metrorrhagia, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • frovatriptanDrug

    Also called frova

    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.

  • frovatriptanDrug

    Also called frova

    frovatriptan 2.5 mg bid or placebo starting on the last day of OC and continuing during the 4 day HFI.

  • placeboDrug

    placebo

Study groups in NCT00700128
Study groupRoleWhat they receive
Group 2ExperimentalFrovatriptan or placebo given in a certain sequence depending on what group that the woman are randomized to.
Receives: Drug: frovatriptan; Drug: placebo
Group1ExperimentalGroup 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.
Receives: Drug: frovatriptan; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

Secondary outcomes (1)

  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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00700128
Sponsor's protocol ID
060714
Acronym
MAM
Status last verified
Jul 2011
First submitted
17 Jun 2008
Last updated
25 Jul 2011
Results posted
No
Data monitoring committee
No

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;

Questions about this trial

What is this clinical trial studying?

A study testing frovatriptan in people with Migraines and Bleeding, run by Scott and White Hospital & Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing baseline menstrually associated migraines (MAMs)to headache occurrence and severity after the implementation of continuous OC therapy. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00700128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.

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