Extended cycle combined oral contraceptives and prophylactic frovatriptan during the hormone-free interval in women with menstrual-related migraines.
BACKGROUND
Migraine headaches are a significant problem for American women with many of them suffering from headaches around the time of their menstrual cycle. Women taking oral contraceptives in the standard 21/7 cycle regimen often suffer from headaches around the time of the hormone free intervals (HFIs) as well. Extended oral contraceptive regimens have been shown to decrease the frequency, but not eliminate these headaches. This study is a double-blind, randomized, placebo-controlled pilot study of participants with menstrual-related migraines (MRMs) who were initiated on extended combined oral contraceptives and given frovatriptan prophylactically during HFIs.


METHODS
Participants having spontaneous menstrual cycles or taking daily combined oral contraceptives in a 21/7 regimen with MRMs were placed on a contraceptive containing levonorgestrel and ethinyl estradiol. Analyses compared headache scores during pre-study baseline cycles to those in a 168-day extended regimen with placebo versus frovatriptan treatments during HFIs.


RESULTS
Daily headache scores decreased (p=0.034) from 1.29 ± 0.10 during pre-study cycles to 1.10 ± 0.14 during extended combined oral contraceptive use. Frovatriptan blocked the increase in headache score over the placebo during HFIs. However, following the withdrawal of frovatriptan, headache scores increased (p>0.01) despite resuming combined oral contraceptive use.


CONCLUSIONS
Extended combined oral contraceptive regimen reduces MRM severity. Frovatriptan prevents headaches during HFIs, but is associated with new headache symptoms when withdrawn.
1 Department of Obstetrics and Gynecology, Texas A&M Health Science Center College of Medicine , Temple, Texas.
Andrea L
AL
Coffee
Patricia J
PJ
Sulak
Alexandria J
AJ
Hill
Darci J
DJ
Hansen
Thomas J
TJ
Kuehl
Jeffrey W
JW
Clark
D000293:Adolescent; D000328:Adult; D002227:Carbazoles / Q000627:therapeutic use*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage*; D008597:Menstrual Cycle; D008598:Menstruation; D008881:Migraine Disorders / Q000188:drug therapy* / Q000517:prevention & control*; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014363:Tryptamines / Q000627:therapeutic use*; D055815:Young Adult
D002227:Carbazoles; D003277:Contraceptives, Oral, Combined; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; D004997:Ethinyl Estradiol; D016912:Levonorgestrel; C108128:frovatriptan