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Brigitte Frey Tirri, Switzerland

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1 Brigitte Frey Tirri, Switzerland
The Emergency contraception Ulipristal acetat and the interaction with hormonal contraception Brigitte Frey Tirri, Switzerland ESC Masterclass Antalya, Turkey 18. May 2017 EllaOne_Interaction with hormonal contraception – Brigitte Frey

2 Conflict of interest ellaOne® Advisory board of HRA-Pharma
Speaker for Gedeon Richter Budapest about emergency contraception (LNG-EC) EllaOne_Interaction with hormonal contraception – Brigitte Frey

3 Overview of available emergency contraceptives (EC)
Inhaltsverzeichnis Overview of available emergency contraceptives (EC) mecanism of action of Ulipristalacetat (UPA) EllaOne® Interaction of UPA with hormonal contraceptives EllaOne_Interaction with hormonal contraception – Brigitte Frey

4 Overview of available emergency contraceptives (EC)
Mechanical : Cupper- IUD (Cu-IUD) Hormonal EC: Levonorgestrel 1.5mg Combined EC (estrogen and progestin, Yuzpe-regimen) Antiprogestins : Ulipristalacetat 30mg (EllaOne®) and mifepriston EllaOne_Interaction with hormonal contraception – Brigitte Frey

5 Mechanism of action of UPA
Second generation progesteron receptor modulator Antiprogestin It mainly delays ovulation by suppressing LH (luteinizing hormone) This effect occurs also after the LH surge and even in some cases after the LH peak+, but not after ovulation* + BracheV et al, Hum Reprod- 2010;25: * LiHWR et all, Hum Reprod. 2016;31: EllaOne_Interaction with hormonal contraception – Brigitte Frey

6 Mechanism of action of EC
Gemzell K., Meng Ch., Int.JWH2010

7 Mechanism of action of UPA
Delay of ovulation of 5 days, time sperms survive in the body Caveat: unprotected sexual intercourse (UPSI) after the intake of a hormonal EC, can lead to an unwanted pregnancy, if the woman doesn’t take another EC. EllaOne_Interaction with hormonal contraception – Brigitte Frey

8 Efficacy of UPA Comparison of UPA, LNG and Yuzpe regimen
Numbers of cycles without ovulation in 5 days time after taking the EC at the time the leading follicule has a diameter of 18 mm. Gemzell K., Meng Ch., Int.JWH2010 EllaOne_Interaction with hormonal contraception – Brigitte Frey

9 Efficacy of UPA after Quickstart with Desogestrel (DSG)
study design: pharmacodynamic, randomised, single-blind, incomplete crossover study 49 patients included, y, BMI < 30 kg/m2 Contraception with condoms, or sexualy inactive during study, or after tubal sterilisation Regular ultrasound, leading follicle ≥ 14 mm < 16 mm, then randomization occured: 3 arms: 30 mg UPA, DSG 75 mcg, the day after UPA for 20 days 30 mg UPA , followed by DSG- placebo the day after UPA for 20 days 30 mg UPA-placebo, followed by DSG the day after UPA for 20 days aim: - influence on efficacy of UPA, (ovarian quiescence and cervical mucus) EllaOne_Interaction with hormonal contraception – Brigitte Frey

10 Efficacy of UPA after quickstarting DSG
n= 29 cycles n= 29 cycles n= 29 cycles EllaOne_Interaction with hormonal contraception – Brigitte Frey

11 Results DSG seams to reactivate the progesterone signaling that leads to follicule rupture, thereby impacting the effectiveness of UPA as EC. UPA on the other hand has almost no influence on the contraceptive efficacy of DSG. No sifgnificant differences were found in time to ovarian quiescence or cervical mucus penetrability EllaOne_Interaction with hormonal contraception – Brigitte Frey

12 Efficacy of UPA after quickstarting DSG
Questions arising out of this study Can these data be transferred on UPA and COC? Can these data be transferred on UPA and other hormonal methods of contraception? Can these data be transferred to other methods of EC? Do we have to wait 5 days after UPA or 5 days after UPSI? What is more dangerous, risking a pregnancy while waiting until starting with a hormonal contraception, or reduced efficacy of UPA? 30% of all women have SI in the same cycle Can these data from a pharmacodynamic study be transferred in clinical practice?, meaning will we have more pregnancies after quickstarting a HC? Is the pill intake before taking UPA influencing the efficacy of UPA? EllaOne_Interaction with hormonal contraception – Brigitte Frey

13 EllaOne_Interaction with hormonal contraception – Brigitte Frey 18. 05

14 Why using a chemical contraceptive for 14 days after UPA
Cameron S.T. et al, hum.reprod. 2015 UPA is not influencing the capability of the COC, to achieve ovarian quiescence - The effect occured in most women after 7 days in all after 14 days - This study design doesn’t allow to say, if the effect of UPA is reduced. EllaOne_Interaction with hormonal contraception – Brigitte Frey

15 Recommendations in different countries
EMA (european Medicines Agency), Swissmedic Continuation / or quickstarting of hormonal contraception after UPA intake Additional use of condoms for 14 days or until next menstruation advantage: Higher Compliance of the patient disadvantage: Risk of reducing the efficacy of UPA  higher pregnancy risk FDA / ICEC/ AJCOG/FSRH/Frankreich /working group of EC 5 (7) days of pause with hormonal contraception or quickstarting Additional use of condoms for (7) 14 days or until next menstruation advantage: No reduced efficacy of UPA disadvantage: Risk to forget to start with the pill EllaOne_Interaction with hormonal contraception – Brigitte Frey

16 Take home messages meta-analysis of data from two large RCTs suggests that UPA is significantly more effective y than LNG at preventing prenancy when taken from h after UPSI. (EL 1+) wait 5 days after UPA before quickstarting a hormonal contraception wait 5 days after UPA before continuing a ongoing hormonal contraception, no direct clinical data for this but theoretical possible use in both above mentioned situations condoms until next menstruation or at least 14 days. 1 FSRH Guideline emergency contraception dec.2016 EllaOne_Interaction with hormonal contraception – Brigitte Frey

17 Thank you for your attention
EllaOne_Interaction with hormonal contraception – Brigitte Frey

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19 EllaOne_Interaction with hormonal contraception – Brigitte Frey 18. 05


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