NCT00700128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

June 17, 2008

Last Update Submit

July 22, 2011

Conditions

MigrainesBleedingSpotting

Keywords

headachesmigrainesbreakthrough bleedingbreakthrough spottingmenstrually associated migrainesbreakthrough bleeding or breakthrough spotting

Outcome Measures

Primary Outcomes (1)

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

    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.

    24 weeks

Study Arms (2)

Group 2

EXPERIMENTAL

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

Drug: frovatriptanDrug: placebo

Group1

EXPERIMENTAL

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.

Drug: frovatriptanDrug: placebo

Interventions

frovatriptanDRUG

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.

Also known as: frova
Group 2
placeboDRUG

placebo

Group 2Group1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Related Publications (1)

  • 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;

    BACKGROUND

Related Links

MeSH Terms

Conditions

Migraine DisordersHemorrhageMetrorrhagiaHeadache

Interventions

frovatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Patricia Sulak, MD

    Scott and White Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(1)