Hot Topics in Contraception The National Association for Premenstrual Syndrome A one day update in Gynaecology 19th June 2015 Hot Topics in Contraception Dr Carrie Sadler, GPSI in Gynaecology Clifton Road Surgery, Ashbourne

Summary New products and facts Cases to illustrate different scenarios: Drug interactions Management of unscheduled bleediing Emergency contraception and quick starting 3

New combined pills Qlaira: natural oestradiol and 2mg dienogest Zoely: natural oestradiol and 2.5mg nomegestrol in a 24/4 regime

Qlaira Regimen 26/2 everyday regimen Maintain stable E2 levels, optimise cycle control, inhibit ovulation The first 2 pills of the Qlaira pack deliver E2 only and no progestogen, this promotes endometrial proliferation, stabilising the endometrium. The endometrium is stabilised before the addition of the progestogen on day 3 of the cycle. The use of DNG ensures suppression of endometrial proliferation and secretory transformation, maturing the endometrium; its stepwise increase further stabilises the endometrium. A progressive oestrogen step-down with two oestrogen-only days at the end of the cycle avoids a rapid decline in oestrogen levels. In the majority of women, the lack of hormones during the placebo days leads to shedding of the endometrium and a withdrawal bleed. (Note that the withdrawal bleed does not necessarily occur during the placebo day; it usually starts during the intake of the last tablets of a pack and may not have finished before the first pills of a new pack are taken). The net result of the Qlaira regimen is a stable endometrium and a good bleeding profile. oestrogen dominant increasing progestogenic activity oestrogen only

Extended use of the combined oral contraceptive Defined as greater than 28 days of active pills consecutively Is an acceptable option with no current safety concerns (longer term data needed) Does the woman wish to reduce the frequency of scheduled bleeding on the combined pill?

Extended use of the combined oral contraceptive- benefits Reduced pill failure May improve compliance Accepted treatment for endometriosis, dysmenorrhoea, heavy menstrual bleeding and menstruation associated symptoms Aids hygiene in women with learning disabilities Unscheduled bleeding decreases with time YAZ Flex: ethinyl oestradiol and drospirenone a 120 day long cycle regime with option of taking 4 day break

Use of combined oral contraceptives and VTE risk: nested case-control studies using the Qresearch and CPRD databases Y Vinogradova, C Coupland and J Hippisley-Cox BMJ, No8010, May 2015 Women with incident VTE diagnoses between 2001 and 2013 were matched to up to 5 controls Included 10,562 cases Risk increase 2 ½ times with current use of levonorgestrel, norethisterone and norgestimate pills 4x risk with desogestrel, gestodene, drospironone and cyproterone Adjusted for smoking, BMI, alcohol intake, ethnic group, other conditions associated with VTE, use of other hormonal contraceptives in last year

Risk of VTE with combined hormonal contraceptives Background risk: 2/10,000 women per year Pregnancy: 29/10,000 women/year 2nd generation pills: 5-7/10,000 women per year 3rd generation pills: 9-12/10,000 women/year Risk less in 20 microg pills compared to 30 microg pills Patch/ring: 6-12/10,000 women/year Qlaira/Zoely: risk not known Norethisterone risk equivalent to 20 microg COC Risk is greatest in first few months of use. If a woman has a break of more than a month her risk goes back to baseline Risk is 5 x greater in women with a BMI > 30

Implants The barium in Nexplanon may be causing more skin reactions There is no increased pregnancy rates demonstrated up to a weight of 149kg. No need to change implant early in overweight women Injectable progestogens Evidence to date suggests no increased fracture risk. About 6% of BMD is lost in first 6 months (similar to breast feeding) Takes 5-6 years for BMD to return to normal > 20 and 18 months < 20

Sayenna Press 104mg of medroxyprogesterone acetate in a 0.65 ml suspension for s/c use Given at intervals of 13 weeks +/- 7 days Mode of action and side effect profile similar to Depo Provera, DMPA May be preferable in women at risk of haematoma and obese women in which there is concern about the correct siting of an IM injection Reactions at the site of injection are more common than with DMPA Potential for self administration- unlicensed use

News on coils FSRH have just published updated guidelines Perforation rate 2/1000 6 fold increased risk of perforation in breast feeding women. This is now thought to be not only due to softer uterus but also due to uterine contractions at time of feeding- so happens after time of fitting Higher risk of perforation when fitting a coil if a woman has been on Depo long term If a woman falls pregnant with a coil in situ ectopic needs to be excluded

News on coils Risk of expulsion is 1 in 20 and this is slightly higher if fitted post abortion Mirena – reduces pain in primary dysmenorrhoea, endometriosis and adenomyosis – unlicensed uses Mirena- provides endometrial protection for up to 5 years (unlicensed) Mirena- good efficacy for up to 7 years

Jaydess Jaydess 28mm in length , Mirena 32mm Jaydess- the ends of the hormone capsule are open (unlike Mirena) causes a greater release of hormone initially. Jaydess more likely to lead to a regular bleed At 3 years 25% amenorrhoeic with Mirena 12% with Jaydess Jaydess introducer diameter less than Mirena Jaydess 6 microgs of levonorgestrel/ day, Mirena 20 microgs Side effect profile similar to Mirena Licensed for 3 years Sliver ring on stem and barium – visible on X ray Mainly works by effect on endometrium

Caya contoured diaphragm One size fits most women >60 and <85mm Up to 18% failure rate in first year Silicone membrane Fit with dome down Removal dome makes it easier to remove Comes with spermicide- Caya gel- use one teaspoon

Caya contraceptive diaphragm

Essure Hysteroscopic sterilization Just started at the Royal Derby : procedure Takes 5-10 mins and is well tolerated without intra-op anaesthesia (Ibuprofen prior to procedure). Patients home after 20-30 minutes Require confirmatory test at 3 months: HSG or scan

Case 1, Drug interactions Alison, aged 28 Taking the combined pill and develops epilepsy. Has just been started on Lamotrigine and has been told that she needs to change to a different method

Lamotrigine and CHCs and some new antiepileptic drugs, AEDs CHCs cause a reduction in lamotrigine levels Also levels of lamotrigine rise on stopping CHCs Using CHCs and lamotrigne is a UKMEC 3 Sodium valproate lessens the effect of oestrogen metabolism on lamotrigine Use of PO methods and lamotrigine is not restricted, UKMEC 1 Two new AEDs Perampanel and Eslicarbazepine are enzyme inducers

Case 2, unscheduled bleeding Karen, Aged 46 Nexplanon in situ for a year Heavy prolonged irregular bleeding for last 3 months Periods scanty and infrequent prior to this No increase in pain, IMB or PCB BMI 30

Unscheduled bleeding Examine if: Persistent bleeding beyond the first 3 months of use New symptoms or a change of bleeding after at least 3 months use of a method If woman has not participated in National Cervical Screening Programme If pain, dyspareunia or postcoital bleeding If medical management fails Exclude STIs ? Endometrial assessment Check cervical screening Consider HCG

Unscheduled bleeding- treatment Combined contraceptive methods: Increase dose of oestrogen (max 35 mcg EE) or change type May help to change progestogen No evidence to date that extended regimes are helpful Progestogen only pill: No evidence that increasing dose helps but this is used Implant, injectable and Mirena: Combined oral contraceptives Mefenamic acid Additional progestogens

Case 3, Emergency contraception and quickstarting Rose, Aged 28 Using Evra patch. Forgets to take new patch in holiday. Presents 14 days after last patch removed. UPSI 4 days ago (condom split)

Incorrect use of the CH patch and vaginal ring If detached for < 48 hours no need for EP EP only needed after extension of PFI by> 48hours or if patch kept on for > 9 days Vaginal ring: EP only needed if RFI is extended by > 48 hours In weeks 2 and 3 it can be left out of vagina for up to 48 hours without affecting efficacy

Emergency contraception- ellaOne Main actions of emergency pills is postponement of ovulation. No effect after LH peak EllaOne-Each tablet contains 30mg of ulipristal actetate and is a progesterone receptor modulator Licensed for up to 120 hours after UPSI and should be used in preference to Levonelle between 72 and 120 hours Use in preference to Levonelle: When weight > 80 kg- Levonelle not as effective When risk of pregnancy is high and a copper IUCD has been declined When between 72 and 120 hours post exposure. Levonelle does not work after 96 hours Levonelle- still has a place after missed pills, when breast feeding and quick starting

Quick starting contraception- unlicensed use If the HP is reasonably sure that a woman is not pregnant from recent UPSI, contraception can be started immediately (unless she wishes to wait until her next period) CHC, the POP and injectable progestogens (second line) can be used as bridging methods Pregnancy must be excluded before starting intrauterine methods (unless criteria for EC met) or cyproterone (Dianette) Following the emergnecy pill starting the CHC.POP, implant and progestogen injection can be considered with a follow up pregnancy test (no sooner than 3 weeks)

Quick starting contraception- unlicensed use Starting hormonal contraception following LNG EC: CHC EP 7 days Qlaira 9 days POP EP 2 days Starting hormonal contraception after ulipristal: CHC EP 14 days Qlaira EP 16 days POP EP 9 days

Thank you Any questions?