1. SEASONIQUE (84 days 30 mcg EE/150 mcg LNG; 7 days 10 mcg EE)
A 91-Day Extended Regimen Oral Contraceptive with Period Stabilizing Pills
quote jvw
follikels
2 vragen:1. wie schrijft pil lang voor
2. wie las de laatste tijd goede evidentie hiervoor?
Conflict of interest

2. The Evidence PubMed and Embase: 390 papers
MA: 21
Review: 104
Clinical trials : 63
Pharmacokinetic studies: 25
Observational studies: 50
Snowballing: 20

3. Why extended regimens ((since 2000)?
Women desiring fewer withdrawal bleeding episodes
Potential medical advantages of extended regimens
Why EE and LNG?
Why HFI with EE: less withdrawal symptoms, greater suppression of the HPO axis,decreased follicular development?

5. Who might benefit? Women desiring fewer withdrawal bleedings
.. Premenstrual syndrome
Menstrual migraine
Endometriosis
Iron deficiency
Obesity
PCO

6. Absorption Elimination
No No Accumulation
half life EE=18 h half life LNG=34h

7. DVT and Observational Evidence

8. HPO axis inhibition by 10 microg EE
-97% ovulation suppression
--improve bleeding profile
-minimise withdrawal symptoms
Vandever MA, Contraception 2008;77

9. Efficacy Pearl Index (pregnancies per 100 women years of use)
(One year of use)
0.76 for typical use
0.26 for compliant use
(Barcelona data 2015 oac: Pearl typical use= 0.8, perfect use= 0,3

10. HowardB, Contraception 2014;89
Comparing Studies
Extended versus Cyclic 21/7: 4.4% versus 7.3% (one year pregnancies) p<0.0001
Extended versus Cyclic 24/4: 4.4% versus 6.9% (p<0.0001)
Seasonique versus 84/7 LNG/EE +placebo: 3.0% versus 4.4% (p=0.02)
HowardB, Contraception 2014;89

11. Bleeding- Spotting data
Cave first cycle: 4-7 days unscheduled
1 day of spotting per each 91-day cycle (Three year extension trial)
less scheduled bleeding:2 days per each 91-day cycle and bleeding is light

12. Anderson FD et al, Contraception 2006;73

13. Safety long term data adverse events endometrial hemostatic
bone mineral density

14. Cardio Vascular Serum Markers
Prothrombin F1-2 > non inferior than LNG/EE, superior to DSG formulas
glucose intolerance
Triglycerides >
Lipoproteins>
RR>
Nappi RE et al, Eur J Contracept RHC 2014

15. Skeletal Growth in adolescents: BMD
increase from baseline lumbar spine not clinical significantly altered after 12 months compared with controls and 21/7 regimens
Cromer B,et al: EBCOG ,Scotland,Glasgow,May 2014

16. Andersen FD et al: Contraception 2008;77
Endometrial Safety
No Endometrial Hyperplasia after 1 year: general shift toward an inactive endometrium during therapy
Andersen FD et al: Contraception 2008;77

17. Wentzensen et al: Lancet Oncology,aug 5,2015
Endometrial Cancer
Fig ltste
Wentzensen et al: Lancet Oncology,aug 5,2015

18. Compliance /User satisfaction
98% overall compliance
95% user satisfaction
Data on file. Satisfaction claims research,New York,sep 2010

19. Long term Tolerability : 4years
as expected for COC's:
overall discontinuation for AE= 9.7 % after 4 years
No DVT
Davis MG et al: J Fam Pract 2010

20. Baumhardt et al: Fert Ster 2009
Return to Fertility
Ovulation activity = 77.1% within 32 days of discontinuation
(Conception rates after 12 months OAC: 78-95%)
Baumhardt et al,Fert Ster 2009
Baumhardt et al: Fert Ster 2009

21. Conclusion wish of patient medical conditions
within extended regimens, Seasonique is a logical choice
effective for the prevention of pregnancy and safe
well tolerated (improved bleeding/spotting profile)