1. Hormonal Oral Contraception Jan Bowden Lecturer Midwifery & Women’s Health 23/11/2016J Bowden Oct 20031

2. Aims of the session: Aims of the session are:  Understand the workings of the oral hormonal contraceptive methods: Combined, Progestogen & Emergency.  Identify the advantages and disadvantages.  Explore issues of care and management.  To be read in conjunction with: To be read in conjunction with:  https://www.fsrh.org/documents/combined- hormonal-contraception/ https://www.fsrh.org/documents/combined- hormonal-contraception/  https://www.fsrh.org/documents/ceuguidan ceprogestogenonlypills/ https://www.fsrh.org/documents/ceuguidan ceprogestogenonlypills/  https://www.fsrh.org/documents/ceu- emergency-contraception-jan-2012/ https://www.fsrh.org/documents/ceu- emergency-contraception-jan-2012/  https://www.fsrh.org/documents/ceu- guidance-drug-interactions-with-hormonal- contraception-jan/ https://www.fsrh.org/documents/ceu- guidance-drug-interactions-with-hormonal- contraception-jan/  https://www.fsrh.org/documents/ceuguidan ceproblematicbleedinghormonalcontracepti on/ https://www.fsrh.org/documents/ceuguidan ceproblematicbleedinghormonalcontracepti on/  https://www.fsrh.org/documents/ceustatem entquickstartingafterupa/ https://www.fsrh.org/documents/ceustatem entquickstartingafterupa/  https://www.fsrh.org/documents/ceuguidan cequickstartingcontraception/ https://www.fsrh.org/documents/ceuguidan cequickstartingcontraception/ 23/11/2016J Bowden Oct 20032 Also review Trust policies

3. Fill in the boxes with the correct terms…….. Predominant Hormone Ovarian Cycle Endometrial Cycle Menstrual Cycle DAY 1 to 14 DAY 14 to 28

4. Answers Predominant Hormone Ovarian Cycle Endometrial Cycle Menstrual Cycle DAY 1 to 14 OestrogenFollicular Phase Proliferative Phase Menstrual (1-7) DAY 14 to 28 ProgesteroneLuteal PhaseSecretory Phase Premenstrual (21-28)

5. Answers Oestrogen  Stimulate growth  Encourage development of the primordial follicles  Inhibits the secretion of FSH  Increases Myometrial Contractivity  Promotes calcification of the bones  Promotes female fat and hair distribution Progesterone  Produces Secretory changes to the endometrium.  Increase growth in myometrium.  Increases fallopian tubes secretions.  Increases fallopian tube motility.  Assists in the development of glandular tissue in the breast. WHAT ARE THE EFFECTS OF EACH

6. Oestrogenic Effects:  Tender Breasts.  Nausea  Vomiting  Bloating  Cx soft high & open.  Clear wet mucus  Fluid retention  Chloasma  Headaches  Worsening migraines  Raised B/P  Altered GTT  Thrombophlebitis.  Abnormal Clotting tests.  PE  CVA  MI  Altered Visual contours  Changes U.T  Changes LFT, Thyroid function & Fat metabolism.  Increases Epileptic fits  Increases fibroid growth.

7. Progestogenic effects  Full breasts  Thick mucus plug  Cx low closed and dry  Raises basal temp (0.2C)  Absent/scanty periods  Oily skin  Acne  Increase facial hair  Increase Appetite  Increase wt  Lower Libido  BTB  Altered Liver function.  Cholesterol concentration in Bile increases  Alters Lipid & Fat metabolism  ? Hair loss  ?Thrombophlebitis  ? Increase candidial infections  ? Increase fatigue  ? Depression

8. Normal Menstrual cycle  Hypothalmic- pituitary-ovarian axis.  Negative feedback.  GNRH= FSHRH LHRH  Where does the COC break this cycle? 23/11/2016J Bowden Oct 20038

9. “Health professionals can be ‘reasonably certain’ that a woman is not currently pregnant………..” 23/11/2016J Bowden Oct 2003 9 Always a good one for the exam…..

10. Criteria for excluding pregnancy (adapted from UK Selected Practice Recommendations for Contraceptive Use)8 Health professionals can be ‘reasonably certain’ that a woman is not currently pregnant if any one or more of the following criteria are met and there are no symptoms or signs of pregnancy:  Has not had intercourse since last normal menses  Has been correctly and consistently using a reliable method of contraception  Is within the first 7 days of the onset of a normal menstrual period  Is within 4 weeks postpartum for non-lactating women 23/11/2016J Bowden Oct 2003 10

11.  Is within the first 7 days post-abortion or miscarriage  Is fully or nearly fully breastfeeding, amenorrhoeic, and less than 6 months postpartum.  A pregnancy test, if available, adds weight to the exclusion of pregnancy but only if ≥3 weeks since the last episode of UPSI.  NB. Health professionals should also consider if a woman is at risk of becoming pregnant as a result of UPSI within the last 7 days and undertake pregnancy testing where appropriate (≥3 weeks since last UPSI). 23/11/2016J Bowden Oct 2003 11

12. Combined Oral Contraceptive (CoC).  Available since 1961 in the UK.  Very popular method.  A safe method.  Dosages have changed over the last 40 yrs.  Efficacy: 0.1 per 100 women yrs (True) 0.3-4 per 100 women yrs (Typical) 23/11/2016J Bowden Oct 200312

13. COC: Main Action  Positive feedback.  Suspends the release of GNRH.  Effectively puts the ovaries in to suspension (Asleep Zzzzz).  Rule of 7!  1st 7 inhibit ovulation  Remaining 14 maintain anovulation 23/11/2016J Bowden Oct 200313

14. COC: Back up action:  Cervical Changes: HOSTILE. Prevents sperm entering  Endometrial Changes: THIN Prevents implantation  Tube Motility affected. SLOWS Slows passage of ovum 23/11/2016J Bowden Oct 200314

15.  Commonly used CoCs contain ethinyloestradiol (EE) plus a progestogen.  Identified by the term “generation”.  Identifed by the term “phasic”.   Can be 21/7 or everyday (ED). 23/11/2016J Bowden Oct 200315

16. “Generation”  CoCs containing more than 50mcgs of Oestrogen are 1 st.  CoCs containing less than 50mcgs plus levonorgestrel, norethisterone, cyproterone acetate or norgestimate are 2 nd.  3 rd generation CoCs contain Desogestrel or Gestodene  Destogestrel and Gestodene are new progestogens.  Have a higher affinity to progesterone receptors.  Bind more strongly.  Increase mechanisms of the CoC with a lower dose.  Have fewer carbohydrate and lipid metabolic effects.  30mcgs-20mcgs most commonly used. 23/11/2016J Bowden Oct 200316

17. “Phasic”  Monophasic – same dosage throughout the 21 days.  Biphasic – designed to be more oestrogenic in the 1 st part of the cycle. Not commonly used in the UK.  Triphasic - mimics the natural fluctuations in the normal menstrual cycle. Increases the progestogen 3 times.  Quadraphasic- designed to be “more Natural” Changes in both the Oestrogen & Progestogen QLAIRA 23/11/2016J Bowden Oct 200317

18. UK Medical Eligibility Criteria:  UKMEC 1 : No restriction for the use of the method.  UKMEC 2: Advantages generally outweigh the risk of use of the method.  UKMEC 3: Risk usually outweighs the benefit of using the method- Expert clinical judgement  UKMEC 4: Unacceptable health risk if used.  Please read the following URL link: 23/11/2016J Bowden Oct 200318

19. UKMEC 1 : Unrestricted Use  Age: Up to 50  Parity  Breastfeeding: Depending on level  Postpartum/post abortion  Past Ectopics  History of pelvic surgery  Minor surgery/VVs  Headaches: non migrainous  Epilepsy: not using liver enzyme inducers  Depressive Disorders  Viral Hepatitis  Anaemias: Thalassaemia, Iron deficiency  Raynauds Disease: primary  Vaginal Bleeding: Irregular not heavy  Endometriosis.  Benign Ovarian tumours  Dysmenorrhoea  Trophoblastic Disease.  Cervical Ectropian.  Breast disease. benign  Endometrial/ovarian ca.  Fibroids  PID, STI, HIV/AIDS  Diabetes: gestational  Thyroid disorders 23/11/2016J Bowden Oct 200319

20. HOMEWORK….. 23/11/2016J Bowden Oct 200320 Review the UKMEC 2 & 3 for the COC

21. UKMEC 4: UNACCEPTABLE RISK SHOULD not be used  Breastfeeding:0-6/52  Smoking: 15p.d  CVD  Hypertension: >160/>95  VTE: Current  Major surgery with prolonged immobilisation  Ischaemic heart disease  CVA & TIA  BMI: 40& over  Migraine headaches with aura.  Trophoblastic disease: Abnormal HCG  Ca Breast  Diabetes with “opathies” >20yrs  Viral Hepatitis  Cirrhosis  Liver tumours 23/11/2016J Bowden Oct 200321

22. Disadvantages 23/11/2016J Bowden Oct 200322  Risk of DVT: Increased 3 fold in smokers  Risk of CVA & MI. Increased 3 fold in smokers  Increase in Hypertension (consistently 140/90+)  Increase in Cx cancer(?):  Ca Breast: increased risk at 1 st use not length /no risk once stopped  Increase in Liver Cancer; rare.  Increase UTIs.  Increase in gallstones & jaundice.  Antibiotics (short term/longterm?!?!?!?)  Wt gain: NO EVIDENCE  Bleeding patterns: can be altered- 3/12  Progestogenic/oestrogenic side effects.

23. Risk of VTEs CircumstanceRisk per 100,000 women years Not using COC/pregnant5 2 nd generation COC?? 3 rd generation COC?? Pregnant?? 23/11/2016J Bowden Oct 200323

24. Risk of VTEs CircumstanceRisk per 100,000 women years Not using COC/pregnant2 (5) 2 nd generation COC5-7 (15) 3 rd generation COC9-12 (26) Pregnant60 23/11/2016J Bowden Oct 200324

25. Advantages.  Prevents pregnancy.  Relieves Dysmenorrhoea.  Controls Menorrhagia  Regulates Menstrual Cycle.  Relieves PMS. 23/11/2016J Bowden Oct 200325 Improves Acne (Dianette) Rheumatoid arthritis: (30%)

26.  Less risk of ectopic pregnancy.  Less risk of benign breast disease.  Less risk of Ca Ovary/Endometrium (50% + 15YRS).  Controls Endometriosis.  Controls functional ovarian cysts.  No risk of overdose.  Ca colorectal:  Reversible immediately.  Return of Fertility.  Less PID (?).  Less risk of Toxic Shock.  Woman controlled.  Not related to sexual intercourse. 23/11/2016J Bowden Oct 200326

27. Combined Patches: EVRA  3 patches.  1 worn for 7 days for 3 weeks.  1 patch free week.  Similar to CoC.  Considered ideal for those with pill taking difficulties.  per 24 hours. 23/11/2016J Bowden Oct 2003 27 Usually 33.9 μg EE and 203 μg norelgestromin

28. Vaginal Rings: NuvaRing ™.  Combined method.  Flexible, transparent ring.  3 weeks of ring use.  1 ring free week.  Similar to CoC.  Not ideal immediately PN 23/11/2016J Bowden Oct 2003 28 EE and etonogestrel at daily rates of 15 μg and 120 μg

29. Which Pill? CoC chosen should:  Provide effect contraceptive control.  Produce acceptable cycle.  Is associated with the fewest side effects.  The lowest dose first. 23/11/2016J Bowden Oct 200329

30. Clinical Management  Full medical/surgical history (inc family)  Social history  BP/BMI (1 st )  Other exams (?!?!)  Identification of actions, advantages & disadvantages  Pill teach  & missed pill routine  Details on prompt medical consultation.  Written information  Screening  Smoking  Wt  Safer sex  3 month appt for follow up then Trust protocol  Clear documentation 23/11/2016J Bowden Oct 200330 QUICK START INFORMATION

31. Progestogen Only Pill (PoP):  Effective oral alternative to the CoC when exogenous oestrogen is not wanted/advised.  Single dose of Progestogen.  Efficacy 0.3 –4 per 100 women yrs.  Efficacy increases with age.  No evidence re heavier women and decreased efficacy  No evidence that change brands improves bleeding 23/11/2016J Bowden Oct 200331 NEVER THE “MINI PILL”

32. Mode of Action  Development of hostile mucus.  Reducing receptivity of the Endometrium.  Reducing tube motility.  Reducing Ovulation. 23/11/2016J Bowden Oct 200332

33. UK MEC: UK MEC 3:  Current Ischaemic Heart Disease: on anticoagulants. (Continuation)  CVA (Continuation)  Breast Cancer 5 yrs  Cirrhosis; Severe  Liver Tumour: Malignant  Drugs that affect Liver Enzymes UK MEC 4:  Breast Cancer: Current 23/11/2016J Bowden Oct 200333 Review the UKMECs for POP 1 &2

34. Disadvantages of the PoP.  Regular Pill taking.  Irregular bleeding.  Increase in functional ovarian cysts.  Increase ectopic pregnancy (?? 1 in 10).  Fluctuations in wt (no strong evidence).  Bloatedness.  Nausea.  Depression(?).  Decreased Libido ( no strong evidence) 23/11/2016J Bowden Oct 200334

35. Advantages of the POP  Lowers risk of circulatory disease/complications.  Lowers the risk of malignant disease.  Well tolerated.  Prevents pregnancy.  A safer alternative for women who can’t take CoC.  Used up to 55 years of age. 23/11/2016J Bowden Oct 200335

36. Cerazette: Desogestrel-only  Potential benefit over tradition POP.  75 mcgs of Desogestrel.  Works in the same way as other POPs EXCEPT it effects ovulation and inhibits it in 97% of women.  12 hour missed window  Beneficial with dysmenorrhea  Rewrites the textbooks as it is has similar benefits as the COC in relation to action and missed pill routine as the coc (without the 7/7 PFI) with the benefits of the POP.  BUT efficacy not significantly different to traditional POPs 23/11/2016J Bowden Oct 200336

37. POP & Enzyme –inducing Drugs 23/11/2016J Bowden Oct 2003 37 Advised to switch to the progestogen-only injectable or intrauterine contraception. For short durations of enzyme-inducing treatment (<2 months) women can continue the POP providing they use additional precautions during treatment and for 28 days afterwards. Women wishing to start the POP after stopping enzyme- inducing drugs should be advised to use condoms until 28 days after the last dose of enzyme-inducing drug.

38. Oral Emergency Contraception – OEC “NEVER MORNING AFTER”  OEC indicated after unprotected intercourse or method failure.  Yupze method (PC4). Now longer used  Mifepristone. A potential method.  Progestogen only method – Levonelle one step, Levonelle 1500.  Levonorgestrel 1.5mg single dose  72hrs  ellaOne™  Ulipristal Acetate:  30mgs single dosage  120 hrs 23/11/2016J Bowden Oct 200338

39. Mode of Action of POEC  Not fully understood.  Not an abortion.  Inhibit/delay ovulation.  Affects endometrium.  Affects ova transportation.  Affects sperm transportation. 23/11/2016J Bowden Oct 200339

40. Advantages/disadvantages  Prevents pregnancy.  No absolute contraindications.  Ease of availability.  Efficacy hard to establish.  Mode of action difficult to explain.  Nausea/vomiting main side effect.  Alteration to next menses. 23/11/2016J Bowden Oct 200340

41. ellaOne™: Single dose 30mgs  Ulipristal acetate: synthetic progesterone modulator.  Binds to progesterone receptors.  Primary action delays/inhibits ovulation PLUS possible alteration to the endometrium.  Licensed up to 120 hrs.  Side effects similar to Levonelle.  Prescription only  Affects progestogen within  contracepton 23/11/2016J Bowden Oct 200341

42. Clinical Management  Careful history from client. Liver enzyme inducing drugs*  Multiple episodes?  Actions/advantages & disadvantages  Written leaflet & good documentation  If pregnancy suspected - pregnancy test.  B/P: health promotion.  Discuss STI assessment  Careful follow up.  Continued contraception/extra protection  ellaOne only ONCE in a cycle 23/11/2016J Bowden Oct 200342

43. HOME WORK:  Review the following methods in terms of: Qlaira,  What it is?  How it works? Main action/backup actions.  Contraindications  Advantages Disadvantages  How to use it?  Review the initiation /continuance of contraception following:  Levonelle  ellaOne 23/11/2016J Bowden Oct 200343 You can be examined on methods you have been asked to review