Progestin-only methods Type or dose of progestagen

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Progestin-only contraception and beneficial effects on migraine Conflicts of interest A d v ise r a n d le ctu re r fo r E X E LT IS Le ctu re s a n d A d v iso ry b o a rd s B aye r Le ctu re s a n

G a b r ie le S u s a n n e M e r k i- F e ld P r e s id e n t E S C U n iv e r s it y H o s p it a l Z ü r ic h S w it z e r la n d ESC Teaching Tool Medical condition session: Migraine and

1 Progestin-only contraception and beneficial effects on migraine Conflicts of interest A d v ise r a n d le ctu re r fo r E X E LT IS Le ctu re s a n d A d v iso ry b o a rd s B aye r Le ctu re s a n d A d v iso ry b o a rd s M S D P r o f. G a b r ie le S u s a n n e M e r k i- F e ld P r e s id e n t E S C U n iv e r s it y H o s p it a l Z ü r ic h S w it z e r la n d ESC Teaching Tool Medical condition session: Migraine and depression Combined hormonal contraceptives can initiate and worsen migraines and increase the risk for ischemic stroke in migraineurs What about progestin-only contraception? G.M e r k i U S Z Progestin-only methods Type or dose of progestagen 19-nortestosteron H OH C CH 2 e generation levonorgestrel Mirena/Kyleena,Jaydess O 3 e generation Desogestrel Cerazette Etonogestrel (3-keto desogestrel) Implanon D e so g e stre l 7 5 m c g 1

Principal aims in the treatment of hormonal migraines P O C u se co n tin u o u s re g im e n Avoid hormone fluctuations and estrogen withdrawal in the natural

n tin u o u s re g im e n a n d e stro ge n -fre e co n tra ce p tio n Pill, Implantat,Injection, (IUS) G.

risk fo r stro ke N o in cre a se d risk fo r ve n o u s th ro m b o e m b o lism B le e d in g n o t p re d icta b le F re q u e n tly a m e n o rrh o e a

with estrogen production Prevents menstrual bleeding (MIRENA) Levonorgestrel 20 -releasing intrauterine system T h e M IR E N A L N G - IU S c a u s e s h ig h ly

2 Principal aims in the treatment of hormonal migraines P O C u se co n tin u o u s re g im e n Avoid hormone fluctuations and estrogen withdrawal in the natural cycle and in CHC and HRT users Pill with Oestrogen + Progestin Progestin-only Methods POC E stro g e n P r o g e s t in C o n se q u e n ce s o f th is co n tin u o u s re g im e n a n d e stro ge n -fre e co n tra ce p tio n Pill, Implantat,Injection, (IUS) G.M e r k i U S Z Levonorgestrel releasing- intrauterine devices Mirena/Kyleena/Jaydess N o h o rm o n e w ith d raw a l (exclu d e d LN G -IU S ) N o in cre a se d risk fo r stro ke N o in cre a se d risk fo r ve n o u s th ro m b o e m b o lism B le e d in g n o t p re d icta b le F re q u e n tly a m e n o rrh o e a Releases Levonorgestrel into the uterus cavity LNG is absorbed only in small amounts Can inhibit ovulation, but mostly ovulation occurs Can induce ovarian cysts with estrogen production Prevents menstrual bleeding (MIRENA) Levonorgestrel 20 -releasing intrauterine system T h e M IR E N A L N G - IU S c a u s e s h ig h ly f lu c t u a t in g e s t ra d io l le v e ls in w o m e n w it h a n d w it h o u t b le e d in g N ie ls e n T h is c a n p r o m o t e m ig ra in e in p r e d is p o s e d Migraine and POC which inhibit ovulation w om en 2

Scientific evidence for im provem ent of m igraine only exists for POP : Desogestrel 75 mcg Incidence for VTE Inhibits ovulation Very low-dosed but as effective as CHC with 20-30mcg EE /150mcg

3 Scientific evidence for im provem ent of m igraine only exists for POP : Desogestrel 75 mcg Incidence for VTE Inhibits ovulation Very low-dosed but as effective as CHC with 20-30mcg EE /150mcg desogestrel) 1.1 / / FJ Desogestrel-only FJ LNG-IUP Lidegaard 2011 Estrogen withdrawal migraine Hormone-withdrawal migraines are: Without aura Difficult totreat Durationover several days Associated with high disability Avoid medication overuse headache What types of migraine are we talking about in the following studies? It is of importance to consider the issue of : Different migraine frequencies! I will talk about studies, in which women suffer from3 and more hormone-relatedand nonhormonal migraines /month Medicationoveruse headache MOH Recommendations are muchlessstrict for women with a single or few migraines per year! G.Merki USZ Clinical trials with migraine and desogestrel 75 mcg Desogestrel-only pill (Cerazette ) in women with migraine with aura Author Study typ n MA/MO sign Nappi et al.2011 Prospective diary-based,15 CHC users, Morotti et al non CHC users,6 months 2011 Retrospective analyses of daily conducted diaries, 3 months Retrospective analyses of MIDAS,3 months Retrospective diary based study, 6 months continuous use of CHC vs. POC users 2014 N=30 MA M-days /y es N=38 MA/MO M-days N=37 MA/MO Quality of life 22 CHC 31 POP M-days Retrospective diary based study, 6 months N=68 MA/MO M-days MO MA No use of hormones for at least 6 months (n=29); Group 2: use of CHC for at least 6 months before treatment (n=35) N=64 MA/MO M-days G1 G2 N=30 Nappi et al

Desogestrel-only pill (Cerazette ) in women with migraine with and without aura Desogestrel-only pill in women with migraine with and without aura Days /month Mean (SD) baseline Mean (SD) Treatm ent

001 Sum headache and migraine Mean headache intensity* 8.3 (4.2) 6.5 (3.7) 0.002 15.7 (10.4) 10.4 (6.4) 0.0001 Ø reduction in migraine days (p<0.003) Ø reduction in all headache days (p<0.

4 Desogestrel-only pill (Cerazette ) in women with migraine with and without aura Desogestrel-only pill in women with migraine with and without aura Days /month Mean (SD) baseline Mean (SD) Treatm ent P - value Subanalysis of only females with MO showed very similar results Headache days 3.1 (3.9) 2.6 (2.8) Migraine days 5.2 (3.6) 3.7 (3.4) Sum headache and migraine Mean headache intensity* 8.3 (4.2) 6.5 (3.7) (10.4) 10.4 (6.4) Ø reduction in migraine days (p<0.003) Ø reduction in all headache days (p<0.02) Ø reduction in days with pain medication (p<0.03) Ø reduction in pain intensity (0.0001) Ø reduction in the number of days with severe pain (p<0.0001) Pain medication 5.7 (3.5) 4.6 (2.5) Merki-Feld et al: Cephalalgia 2013; n=58 3 months treatment, n=38 Merki-Feld et al: Cephalalgia 2013 Positive effects of the progestin desogestrel 75 μg on migraine frequency and use of acute medication are sustained over a treatment period of 180 days. Desogestrel-only contraception may reduce headache frequency and improve quality of life in women suffering from migraine Merki et al.: J Head Pain 2015 Differences in MIDAS grades between baseline and during three months of treatment with desogestrel 75 μ g. For each difference ( 1 to 3) the absolute number of patients is mentioned. Positive differences indicate improvement, 0 means no change, and negative differences indicate worsening. Merki-Feld et al 2013: The European Journal of Contraception & Reproductive Health Care Improvement of migraine with change from combined hormonal contraceptives to progestin-only contraception with desogestrel: How strong is the effect of taking women off combined contraceptives? Headache frequency and intensity in female migraineurs using desogestrel-only contraception: A retrospective pilot diary study Gabriele S Merki-Feld, Cephalalgia

Reactions on desogestrel 75µg can be very individual Progestin-only contraception compared with extended combined oral contraceptive in women with migraine without aura: a retrospective pilot study

Frequently it is possible to take women off prophylactic agents after longer use of Desogestrel 75µg Data: G.Merki University Hospital Zürich Morotti et al.:eur J Obstet Gynecol Reprod Biol.

during months 2 and 3 of the desogestrel pill Progestin implants and injection Caution with longterm methods, because patients react individually and progestin rarely can act as a migraine trigger as

5 Reactions on desogestrel 75µg can be very individual Progestin-only contraception compared with extended combined oral contraceptive in women with migraine without aura: a retrospective pilot study Improvement of migraine around 70-75% in women, mostly without improvement with prophylactic agents Worsening on the longterm 10-15%* 20% no improvement but safe and effective contraceptive Frequently it is possible to take women off prophylactic agents after longer use of Desogestrel 75µg Data: G.Merki University Hospital Zürich Morotti et al.:eur J Obstet Gynecol Reprod Biol Case POP 28 year old woman with MO frequency of migraine increased last two years Uses CHC since 5 years Around 6-8 attacks monthly, Particularly strong in the pill-free interval Under CHC and during months 2 and 3 of the desogestrel pill Progestin implants and injection Caution with longterm methods, because patients react individually and progestin rarely can act as a migraine trigger as well Caution, no data Levonorgestrel 20 -releasing intrauterine system Conclusions The M IRENA LNG-IU S causes highly fluctuating estradiol levels in w om en w ith and without bleeding Nielsen 1984 Caution, effect on migraine not predictable, in spite of amenorrhoea Migraine is a disabling neurologic disease that places an enormous burden on patients There agents is with a high better unmet tolerability need for efficacious therapies and prophylactic Migraineurs are at increased risk for ischemic stroke This risk multiplies with the use of CHC Women suffering frommigraine with aura should not use combined hormonal contraceptives WHO 4 Combined hormonal contraceptive can initiate and worsen migraines and potentially increase the risk for ischemic stroke in migrainuers Several studies indicate that desogestrel 75µg has a positive impact on the course of both migraine with aura and migraine without aura The POP does not increase the risk for stroke Copper-IUDs do not exert negative effects in migraineurs 5

prevalence was 13.8% among females

prevalence was 13.8% among females 1 2 3 1. Woldeamanuel YW et al. Migraine affects 1 in 10 people worldwide featuring recent rise: a systematic review and meta-analysis of communitybased studies involving 6 million participants. J Neurol