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.

STUDY DESIGN:

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: Rossella E Nappi, Erica Terreno, Grazia Sances, Ellis Martini, Silvia Tonani, Valentina Santamaria, Cristina Tassorelli, Arsenio Spinillo
• Journal: Contraception (Contraception) Vol. 88 Issue 3 Pg. 369-75 (Sep 2013) ISSN: 1879-0518 [Electronic] United States
• PMID: 23453784 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Analgesics
• Contraceptives, Oral, Combined
• Drug Combinations
• estradiol valerate-dienogest
• dienogest
• Estradiol
• Nandrolone

Topics

• Adult
• Analgesics (administration & dosage)
• Body Mass Index
• Contraceptives, Oral, Combined (administration & dosage)
• Drug Combinations
• Dysmenorrhea (complications, drug therapy)
• Estradiol (administration & dosage, analogs & derivatives)
• Female
• Humans
• Italy
• Menstruation
• Migraine Disorders (drug therapy, etiology, physiopathology)
• Nandrolone (administration & dosage, analogs & derivatives)
• Pilot Projects
• Prospective Studies
• Treatment Outcome