title: Effect of a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) in women with menstrually-related migraine (MRM).
abstract: BACKGROUND
  Combined hormonal contraception might worsen migraine in sensitive women, especially during the free-hormone interval, and raise concerns about the vascular risk. The characteristics of a contraceptive pill containing estradiol valerate/dienogest (E2V/DNG) might be of potential benefit in women with menstrually related migraine (MRM) who choose to use oral contraception for birth control.
  
  
  METHODS
  This was a prospective diary-based pilot study. Thirty-two women (age >35 years) [n=18 who had never used combined oral contraceptives (COCs) and n=14 who had previously used COCs] diagnosed with MRMs according to the International Headache Society criteria were included. During the observational period, women filled in a diary with the clinical characteristics of migraine attacks. After a three-cycle run-in period, each subject received a COC containing E2V/DNG (Qlaira®/Natazia®; Bayer HealthCare, Berlin, Germany) administered using an estrogen step-down and progestogen step-up approach. Follow-up evaluations were scheduled at the last cycle of run-in and at the third and sixth cycles of treatment.
  
  
  RESULTS
  The number of migraine attacks was significantly reduced at the third (p<.001) and sixth cycles (p<.001) in comparison with the run-in period. A similar result was evident for the duration (p<.001 at the third and p<.001 at the sixth cycle) as well as for the severity of head pain (p<.001 at the third and p<.001 at the sixth month). Indeed, a significantly lower number of analgesics were used at the third cycle (p<.001) in comparison with baseline, and a further decrease was evident at the sixth cycle (p<.001) in comparison with the third cycle of E2V/DNG use. Interestingly, duration and severity of head pain were significantly correlated with the number of days of dysmenorrhea at the third cycle (r=.89, p=.000 and r=.67, p=.02; respectively) and at the sixth cycle (r=.76, p=.000 and r=.62, p=.04; respectively) in women without complete remission of menstrual cramps during the study period.
  
  
  CONCLUSIONS
  The present diary-based pilot study indicates that the use of a pill containing EV2/DNG for six cycles has a positive effect in women with MRM and suggests an association between dysmenorrhea with COCs use as a potential feature of refractory head pain.
authors: Department Obstetric and Gynecology, University of Pavia, Italy. renappi@tin.it
authors: Rossella E
authors: RE
authors: Nappi
authors: Erica
authors: E
authors: Terreno
authors: Grazia
authors: G
authors: Sances
authors: Ellis
authors: E
authors: Martini
authors: Silvia
authors: S
authors: Tonani
authors: Valentina
authors: V
authors: Santamaria
authors: Cristina
authors: C
authors: Tassorelli
authors: Arsenio
authors: A
authors: Spinillo
mesh_terms: D000328:Adult; D000700:Analgesics / Q000008:administration & dosage; D015992:Body Mass Index; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000150:complications / Q000188:drug therapy; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007558:Italy; D008598:Menstruation; D008881:Migraine Disorders / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; C023635:dienogest; D004958:Estradiol; D009277:Nandrolone
keywords: Bleeding; Dienogest; Dysmenorrhea; Estradiol valerate; Hormonally associated headaches; Migraine without aura