Emergency contraception, including ellaone (based on FSRH/CEU Guidance)

Transcription

1 Emergency contraception, including ellaone (based on FSRH/CEU Guidance) Dr Lynsey Dunckley Associate Specialist SRH Southampton Solent Sexual Health Conference Friday 25 th January 2013

2 Quiz!

3 Which is true? A: with increased choice of oral methods, the coil is no longer considered first line emergency contraception B: Levonelle One Step is no longer available in the UK C: The Mirena IUS does not work as emergency contraception D: ellaone is a hormonal method of emergency contraception

4 Which is true? A: with increased choice of oral methods, the coil is no longer considered first line emergency contraception B: Levonelle One Step is no longer available in the UK C: The Mirena IUS does not work as emergency contraception D: ellaone is a hormonal method of emergency contraception

5 Facts LMP = Day 1 of menstruation Follicular phase & ovulation may vary Luteal phase relatively constant (~14 days) Sperm survival - up to 7 days; Ovum - up to 24 hrs Pregnancy begins at implantation, not fertilisation Mean time from ovulation to implantation 9 days (range 6-18) Wilcox et al. Time of implantation of the conceptus and loss of pregnancy. N Engl J Med 1999; 340:

6 EC and the menstrual cycle Copper IUD Oral EC Copper is toxic to sperm & ovum Effective immediately Prevents fertilisation Prevents implantation Fit before implantation Incompletely understood Inhibits or delays ovulation by which time sperm non-viable Does not disrupt an implanted embryo No adverse pregnancy outcomes

7 Emergency IUD e.g. T-Safe 380A QL TT 380 Slimline Nova-T Offer to all Within 120 hours of first episode UPSI OR Multiple UPSI: within 5 days of earliest expected date of ovulation Up to Day 15 of an extended COC pill free interval (ovulation D for implantation=d15)

8 IUD Advantages Highly effective (FR < 1%) Long-term contraception Can be used > 120 hours after UPSI Disadvantages Painful Failure to insert Complications (e.g. pain, bleeding, expulsion, perforation) STI considerations Time & training

9 Levonelle Levonelle One Step Levonelle Levonelle 1500 mcg levonorgestrel = 50 x Norgeston POPs (30 mcg LNG) Within 72 hours of UPSI (unlicensed up to 120 hours) Primarily inhibits ovulation (for 5-7 days) if taken prior to LH surge Poor/no efficacy immediately prior to ovulation or once process of fertilisation has occurred

10 Levonelle efficacy Efficacy demonstrated up to 72 hours. Overall FR 1-3%. Contraception 2011; 84:35 39: Combined data from four WHO RCTs Risk of pregnancy on Days 2, 3 and 4 after UPSI was not significantly different from that on Day 1, suggesting efficacy up to 96 hours [OR 0.68, 95% CI ; 1.74, 95% CI ; and 0.87, 95% CI , respectively] Compared to Day 1, LNG administered on Day 5 (120hrs) increased the risk of pregnancy nearly six-fold [OR 5.81, 95% CI ] It is therefore not certain whether LNG administration on Day 5 offers protection against unintended pregnancy.

11 ellaone 30mg ulipristal acetate Introduced Autumn 09 Selective Progesterone Receptor Modulator (derivative of 19-Norprogesterone) Licensed for use within 120 hrs of UPSI or contraceptive failure Primarily inhibits or delays ovulation Can suppress growth of lead follicles Can prevent ovulation after LH surge has started Ineffective at time of LH peak Endometrial effect but unknown whether inhibits implantation Can be offered to all eligible women requesting EC up to 120 hours (FSRH)

12 Efficacy of ellaone Sustained efficacy up to 120 hours [Fine et al 2010; Glasier et al 2010] At least as effective as Levonelle within 72 hrs [2 x randomised, non-inferiority trials Glasier et al. 2010, Creinin et al. 2006] Trials showed non-significant trend to lower pregnancy rates with ellaone Data combined in meta-analysis [n = 3,445] Difference in pregnancy rates was significant and in favour of ellaone [0-72hrs: OR % CI ; hrs: 0.55, 95% CI ] NB different UPA treatment regimens, CI wide, noninferiority studies

13 UPSI/barrier failure Indications for EC: COC Patch Ring POP Injectable IUD/IUS If two or more pills are missed in Week 1 and UPSI occurred in Week 1, or the pill-free week Existing patch remains applied for more than 9 days or patchfree interval exceeds 9 days Existing ring in situ 5 weeks and new ring not inserted immediately, or ring-free interval exceeds 9 days If one or more pills have been missed or taken >3 hours late (>12 hours late for Cerazette) and UPSI has occurred in the 48 hours following this If the contraceptive injection is late (>14 weeks for Depo-Provera or >10 weeks for Noristerat ) Complete or partial expulsion, perforation, or removal of an IUD/IUS is necessary and UPSI has occurred in the last 5 days

14 Which is true? A: If a copper IUD fitting is deferred, don t supply oral EC this is a waste of resources. B: Be cautious about issuing Levonelle multiple times in a cycle this may not be safe. C: Be cautious if the woman has had an ectopic pregnancy in the past. Oral EC and the copper IUD can increase the risk. D: Emergency contraception? The copper IUD is best! E: Make sure you exclude pregnancy before starting a regular method of contraception.

15 Which is true? A: If a copper IUD fitting is deferred, don t supply oral EC this is a waste of resources. B: Be cautious issuing Levonelle multiple times in a cycle this may not be safe. C: Be cautious if the woman has had an ectopic pregnancy in the past. Oral EC and the copper IUD can increase the risk. D: Emergency contraception? The copper IUD is best! E: Make sure you exclude pregnancy before starting a regular method of contraception.

16 Special considerations ellaone & hormonal contraceptives: EP for 7 days PLUS the usual LEIs: double dose Levonelle (3mg); do not use ellaone Drugs that increase gastric ph: do not use ellaone Vomiting: seek advice within 2 hrs of levonelle or 3 hrs of ellaone Menstrual disturbances: HCG 3 weeks if any doubt Multiple use: -Levonelle : may be used more than once in a cycle, even if earlier UPSI and EC given (no UKMEC contra-indications) -ellaone : not if another UPSI >120 hours in that cycle (European register to monitor outcomes of exposure during pregnancy) ellaone cautions: severe uncontrolled asthma, hepatic dysfunction, galactose intolerance/lapp lactase def/glucose-galactose malabsorption, breastfeeding (not for 36 hrs)

17 Emergency contraception as regular contraception? Halpern et al; Cochrane Database Syst Rev 2010;1:CD007595: LNG administered on a regular basis for pre- and post-coital contraception seemed reasonably efficacious and was safe. Raine et al; JAMA 2005;293:54-62 and other studies: EC has been shown to reduce the risk of pregnancy at an individual level No impact on overall unintended pregnancy or abortion rates in women with increased access, including advance provision or at a population level (not used on every occasion or by those women most at risk) Advance provision: consider on an individual basis as women more likely to report use of EC & use it sooner

18 Discuss on-going contraception and Quick Start Quick Start: -Combined Hormonal Contraception -Progestogen Only Pill -Implant -(Injectable) Quick start and extra precautions: -after Levonelle : 7 days for CHC (2 days for POP, 9 days for Qlaira) -after ellaone : 14 days for CHC (9 days for POP, 16 days for Qlaira) Urine HCG 3 weeks