BRIEF UPDATE  ON  CONTRACEPTION, by John Guillebaud (JG)

 

WHO CLASSIFICATION OF CONTRAINDICATIONS (for any method) - with some amplifications by JG

 

WHO 1:  A condition for which there is no restriction for the use of the contraceptive  method

               “A” is for ALWAYS USABLE [eg COC with history of Candidiasis; uncomplicated varicose veins]

WHO 2:  A condition where the advantages of the method generally outweigh the theoretical or proven risks

               “B” is for BROADLY USABLE [eg COC in heavy smoker age 20; history of hypertension in pregnancy]

*************************************************************************************************

WHO 3:  A condition where the theoretical or proven risks usually outweigh the advantages (suggest alternative).  Yet respecting the patient/client's autonomy - if she accepts risks and relevant alternatives are contra-indicated or rejected, given the risks of pregnancy the method can be appropriately used with maybe special regimen/monitoring

   “C" is for CAUTION/COUNSELLING, if used [eg COC in diabetes; use of an enzyme inducer drug     (EID) with a hormonal method]

WHO 4:  A condition which represents an unacceptable health risk

               "D" is for DO NOT USE, at all [eg COC with personal history of VTE; or migraine with aura]

Notes: Clinical judgement is required, in consultation with the contraceptive user, especially in all category WHO 3 conditions.  If more than one condition applies, as a working rule, two category 2 conditions moves the situation to category 3; and if any category 3 condition applies, adding either a 2 or a 3 condition normally means WHO 4. [References: WHO Medical Eligibility Criteria (WHOMEC) and Selected Practice Recommendations (WHOSPR) for contraceptive use, Geneva: WHO, 2004; or on website at:  www.who.int/reproductive-health. UK version = UKMEC is available at: www.ffprhc.org.uk/admin/uploads/UKMEC200506.pdf ]

                                                                                                                                                                                                                                         COMBINED ORAL CONTRACEPTIVES (COCs). NB glossary of abbreviations is at end, in order mentioned)

Cancer risk: Good news! Hannaford et al (elec BMJ, doi:10.1136/bmj.39289.649410.55 12th Sept 2007) using RCGP study data – one million woman-years of follow-up – reported ↓risk of colo-rectal Ca (looking highly probable now, given earlier data); not just ↓Ca ovary and ↓Ca endometrium.  They also confirm earlier US study [1] of 4575 women aged 35-64 with breast cancer and matched controls showing no increased risk – OR 1 or less - whether for current users, past users, long-term users, users starting at a young age or before full-term pregnancy (no evidence of the so-called “time-bomb”) or even users with a family history! Reassuring, given volunteers’ Pill exposure >75 %, though not the “last word”. Study [1] did not recruit COC-continuers right up to menopause, nor EARLY Ca’s developing pre-age 35. For latter we still use the 1996 model, equating to 1:1000 extra cases by age 45, if they used COC till 35 [2].

Cervical cancer: almost the only bad news re cancer.  Once the oncogenic HPV virus is acquired, Hannaford et al supports the 2002 study [3] that identified the COC as a co-factor for CIN progressing to more advanced stages (the rel. risk of invasive Ca up 4-fold after 10 years’ COC use). But in the UK, invasive Ca cervix risk should be minimal for COC-users (even if smokers), so long as there is 3-yearly cervical cytology, plus colposcopy and treatment as indicated.                                                  

Risk of VTE: Term “Generations” unhelpful, main thing is that LNG/NET progestogens may rather minimally reduce VTE risk, for given EE dose. Using the absolute rates for idiopathic VTE given by the CSM in 1999 (other estimates exist eg EURAS), with around 100 extra cases per million users per year, and assuming 2% mortality for VTE gives 2 per million difference in annual VTE mortality between 3rd gen DSG/GSD products and 2nd gen LNG/NET products. One hour of driving gives a 1 per million mortality risk. So if a pill-taker chooses to switch from Microgynontm to say Marvelontm/Femodenetm, as she sensibly may to control any minor side effect: if she avoids one 2-hour drive in a whole year, she will have the same overall VTE risk next year as she would otherwise have if she did not change brands! [2].

Risk of arterial disease:  Later and probably better study [4] contradicts ‘MICA’ [5] in suggesting that pills with 3rd gen progestogens may actually be better than LNG ones for risk of myocardial infarction.  So, pending more data, I advise that we generally use 20 mg DSG or GSD products for risk-factor and migraine-free COC-users above age 35, through as some may request to age 50-1; with the NET option (Loestrin 20) an alternative.  NB: at any age the primary reason for using, or changing to, a DSG/GSD or other estrogen-dominant product remains the control of side effects [2,6].                              

Migraine with aura, even without the COC (worse with it) is a definite risk factor for ischaemic stroke, indeed it is now less sure there is any added risk in migraine without aura.  Tips for diagnosing:

First establish the timing: neurological symptoms of aura begin before the headache itself, typically last around 20–30 minutes, max 60 minutes, and stop before the headache (which may be very mild). Headache may start as aura is resolving or after up to one hour.

BUT all non-EE-containing methods are OK for women with aura – warn that the headaches may persist, the switching is for greater safety against stroke.

Clinical implications - taking an aura history (Anne MacGregor, personal communication [6]:

In summary, aura has three main features:

1          Characteristic TIMING: Onset BEFORE + Duration ≤1 hour + Resolution before or with onset of headache

2          Symptoms VISUAL (99 %)

3          Description VISIBLE (using her hand)

COC Mortality

Reassuringly, COCs have their main (small) effect on every known associated cause of mortality during current use. The  xs thrombotic risk has vanished by 4 weeks. By 10 years all-cause mortality in past-users equals that for never-users [7].

Prescribing:  In 1996 an international consensus meeting stated “there are only two pre-requisites for the safe provision of COCs”: a careful personal and family history to identify all cardio-vascular risk factors including migraine, and a well-taken blood pressure [8].  But they should also have highlighted the BMI [2,6] as another pre-requisite since a BMI of anything above 30 is WHO 3 (meaning an alternative is always preferred) and above 40 is WHO 4. Routine screening by any blood test, and breast/bimanual examinations are however irrelevant to the COC per se, do them only if clinically indicated.                                        It is Good Practice, after (in JG’s view) initial c15 months of more frequent follow-up, for healthy users with no problems and a good blood pressure, to provide one year’s supply at a time (ie 12-13 packs!) – as now advised by WHOMEC and UKMEC.

Intercurrent diseases [6]:  It is impossible to list every known disease which might have a bearing (ie WHO 4, 3 or 2) on COC prescription, and for many the relevant usage data do not exist. A working rule therefore is to ascertain whether or not the condition might lead to summation with known major adverse effects of COCs, particularly with the risk of any circulatory disease. This usually means WHO 4, sometimes 3. If not, COCs are WHO 2, though even so we need to be alert for the onset of new risk factors. Reliable protection from pregnancy is often particularly important in these cases.              NB: Beware, again, the dis-ease of OBESITY....

Counselling should be backed by the fpa leaflet “Your guide to the combined pill”.  NB: New edition (April 2005) has, as always, very good text, now based on UKMEC and SPR of WHO (ref above). But its Flow Diagram re missed pills on pp 12-13 is disappointing. JG’s practice until the much-needed revision of this chart is to modify it on pp 12-13 and (along with most UK providers, I understand) to give the WHO advice for 20 μg pills whatever the COC. This caution is only logical, given the huge between-women variability of ovulation suppression with any strength of pill.

FOR NOW, therefore, I recommend a dedicated separate patient instruction card making 3 simple points:

  1. Whenever “more than one tablet missed”, now meaning > 24 hours late, use CONDOMS as well for 7 days, +:
  2. If any pill missed in the 3rd active pill-week, RUN ON to the next pack (skip any placebos) +:
  3. In 1st week emergency contraception (EC) needed IF, with sexual exposure since last pack, she is a              ‘LATE RESTARTER’ by > 2 days or has missed >2 first week pills.

What if there were to be no pill-free intervals (PFIs) at all? Missed-pill advice would boil down to one instruction! Also cyclical symptoms (the bleeds themselves, PFI-linked headaches and the PMS that some COC-users report) would be reduced.  Hence the new enthusiasm for continuous 365/365 pill-taking[9]. Surprisingly, very low-dose (20 mcg) pills seem to work best – and Lybrel (continuous EE 20/LNG 100) is already on some markets. Edelman et al in an RCT of LNG versus NET formulations found that continuous use of an equivalent pill to Loestrin 20 was the best for producing amenorrhoea[10]. Some women may choose this option now on an unlicensed/Named Patient use basis[25]), but they need warning that usually light but v. unpredictable spotting is likely, esp. early on.  What they don’t have, of course, is the certainty of 36 to 48 regular bleeding days per year, as they would on any normal 21/7 regimen. NB: While waiting for this option in UK, why don’t we help normal pill-taking even now, by always offering Microgynon 30 ED??  It is cheaper than Microgynon.

 

 YASMINtm containing Drospirenone 3.0 mg drospirenone and ethinylestradiol (EE) 30 mg.  Drospirenone differs from other progestogens in COCs:  it has diuretic properties due to anti-mineralocorticoid activity. This may help to oppose the salt and fluid-retaining effects of EE and so reduce fluid retention symptoms.

Drospirenone is also an anti-androgen, so Yasmin is an alternative to Dianettetm for acne and even established PCOS. The combination with EE is similarly estrogen-dominant, but so far no added risk of VTE has been established.

ELIGIBILITY. Yasmin adds some new WHO 4 conditions: this particular brand should not be used – if COCs usable at

all – in anyone at risk of high potassium levels (i.e. on K - sparing diuretics or severe renal, hepatic or adrenal disease).

 

Q:   On what criteria will you consider Yasmin?    A:   The need for contraception, PLUS:

¨    Need for estrogen/anti-androgen therapy (significant acne, PCOS). I find Marvelon if well ‘sold’ is often best for maintenance treatment following Dianette or other PCOS treatment.

¨    As a useful second choice for empirical control of a minor side effect, esp one judged to be fluid-retention-linked.

What about weight? Not usually an indication, given the lack of evidence of a true (ie non-fluid-related) weight benefit of the product and extra cost. Also if a woman already is overweight, the usual BMI advice should apply ie BMI > 30 is WHO 3 (=  another contraceptive preferred) and BMI > 40 is WHO 4 for all EE-containing products (COCs, EVRA, NuvaRing).

 

EVRAtm transdermal combined hormonal contraception

This innovative transdermal patch delivers 20 µg ethinylestradiol (EE) with 150 µg norelgestromin, the active metabolite of norgestimate, through the skin to produce blood levels in the range of those after a tablet of Cilest. All the absolute and relative contraindications plus most practical management advice about that relatively estrogen-dominant COC apply here. Each patch is worn for 7 days, for 3 consecutive weeks followed by a ‘patch free week’ which (like the PFI) must never be longer. The hormones are in the glue, so a dried-out fallen-off patch should NOT be re-used! 

 

PROGESTOGEN-ONLY PILLS (POPs)

Cerazettetm: the first POP to be primarily an anovulant.  This contains desogestrel 75 mg, blocks ovulation in c 97% of cycles, plus usual mucus back-up: hence ‘perfect-use’ efficacy better than any previous POP study, Pearl Index 0.17 (CI 0-0.9). A bit like ‘oral Implanon! So this is a realistic alternative if the COC is WHO 4 or 3 in any young woman: though old-type POPs suffice in low fertility states like lactation or above age 40, where POP already is so effective.  It is also a good option with high risk of thrombosis – eg to cover major or leg surgery or varicose vein treatments - or (unlike other POPs) a past ectopic. Often, but not very predictably, it benefits menstrual symptoms: eg dysmenorrhoea, menorrhagia, PMS, Mittelschmerz. BUT should warn that unacceptable irregular bleeding may occur early on, usually improving: so that at one year 50% have oligo-amenorrhoea. There are no current concerns re need to increase dose in women of high BMI, at least up to 100 kg.

POPs and hepatic enzyme inducer drugs (EIDs): to give eg two Cerazettes daily while on EIDs is acceptable, but NB is an unlicensed use [25] and not advised by the manufacturer, Organon.

Missed Cerazette pills:  12 hour leeway in pill-taking is now approved, before extra precautions advised – but, for ALL POPs (Cerazette included), in the latest UKMEC/WHOSPR these need only be for 48 hours after restarting the POP tablets (preceded by EC if sexual exposure while the mucus block was lost). [NB Organon's own advice cannot deviate from their SPC, with the stricter requirement for 7 days’ added contraception if a tablet is taken > 12 hours late].

 

INJECTIONS/IMPLANTS   [NB re all long-acting methods, see the excellent reference 11 from NICE]

ImplanONtm is a single 40mm x 2mm subdermal rod releasing etonogestrel (the biologically active metabolite of desogestrel) over 3 years[12]. Its failure rate (c 5:10,000) - if actually inserted, and assuming insertion not too late in a conception cycle, indeed best to avoid that risk through using  an anovulant method pre-insertion - is unmatched: aside from abstinence and vasectomy. Mean insertion and removal times are well under 5 minutes. Yet, NB, special insertion training is vital: removal if too deep can be complex, under ultrasound control. Should contact Organon for advice re imaging and removal in such cases. Frequent or prolonged bleeds affect around a fifth of users at one year. But there are no current worries here re bone density (cf DMPA below), so the high amenorrhoea rate is a bonus!

Irregular bleeding: With both DMPA (below) and Implanon, if irregular bleeding is shown not due to disease (eg Chlamydia) and is unacceptable – consider trial of a suitable 20-30 mg COC for around 3 cycles. Marvelon with the same progestogen as Implanon usually controls the bleeding while the tablets are being taken, with shedding by ‘pharmaco-logical curettage’ between packs of her spotting-prone endometrium. Thereafter the woman  may (or may not!) obtain an acceptable bleeding pattern - though she should be pre-warned that it is unlikely to be so good as during the short-term COC. The latter is repeatable prn. If the combined pill is WHO 4, an effective alternative short term in a pilot study is doxycycline 100 mg bd for 5 days [13] (probably independent of effect on Chlamydial endometritis, but test for this first).

Implanon and body weightIn studies, the blood levels of etonogestrel were lower in obese women, so it has been suggested that in those with the very greatest body mass (say well over 100 kg) it may be appropriate as stated in Organon’s  SPC to discuss replacing their Implanon early, especially if they have stopped being oligo-amenorrhoeic (which would suggest continuing anovulation) in the third year. However there is still (2007) no evidence of excess conceptions in such cases, presumably because of the ‘margin’ in this method, having such high efficacy overall.

Implanon and (EIDs):  The SPC says that these may lower the blood levels of etonogestrel, but there have been no specific interaction studies. Therefore women on short term treatment with any of these drugs are advised to use a barrier method in addition and (because reversal of enzyme induction always takes time) for 28 days thereafter. During long-term EID treatment, Organon recommends transfer to a non-hormonal method and removal of the Implanon.  This seems a bit wasteful, may be resisted by satisfied users and those in monogamous relationships may hate to use barriers long term.  Since measured etonogestrel levels are higher in the first 18 months one might instead (JG’s opinion) consider replacing more frequently, say every 12-18 months; or try to compensate for the enzyme induction by eg a daily Cerazette. The latter prescription would be unlicensed and must be strictly on a “named-patient”* basis [2, 25].  Moreover EID users do very well with DMPA or Mirenatm  so these are normally better choices.

DMPA, Depo-Provera, 150 mg 12 weeklyNB: liver's clearance of the MPA progestogen from the blood is so complete that the same injection frequency is now advised even if the user is on an enzyme-inducer....

Late injections (JG’s preferred advice):

¨      abstinence (best) or

¨      ultra-careful use of condoms OR

¨      a POP, a most useful option here, continued until one is confident there is no blastocyst ‘on the way’.   No evidence to suggest any POP would not be entirely safe, for a pregnancy, if she were to conceive

Then, if –ve pregnancy test, give delayed DMPA dose plus 7-day condom advice or the POP for further 7 days.                                          (Pregnancy test generally repeated later too, for final confirmation..) 

How long to use DMPA? given the ongoing concern about low estrogen in some women. Uncertainty persists, not all removed by the CSM circular (18/11/2004) which mainly advised “careful re-evaluation of risks and benefits in all those who wish to continue use for more than 2 years”. In summary: IF strong risk factors for osteoporosis already exist, for all such DMPA is WHO 3 or even 4. Under age 19, due to concern that it may prevent achievement of peak bone mass, WHO classifies DMPA as WHO 2; and the UK advice of Nov 2004 is to use it first-line “but only after other methods have been discussed” and are unsuitable or unacceptable.  DMPA is also WHO 2 above age 45 (as ? beginning ovarian failure). In sum, DMPA is very useful for fairly short term use, after which switching to another long-term method is usual. If the woman wishes to use it for longer, even much longer, it is as always her right to decide to do so, after counselling about the uncertainty. This should be with formal 2-yearly reassessment of alternatives but without bone scanning or blood tests unless clinically indicated for that woman. Remember DMPA is clearly safer, overall, than the COC!

Same problem with long term Implanon? No, the data are reassuring so far, re both estradiol and bone density: in comparative 2-yr. studies both remained similar to those in copper IUD-users.  By analogy, no worries yet on this account with Cerazette either - nor with the LNG-IUS, whose amenorrhoeic action is primarily at the end-organ, the endometrium.

 

INTRAUTERINE DEVICES (IUDs) = ‘reversible sterilization’?! (see below discussion of Peterson ref [19]

Any banded Cu IUD is in the ‘gold standard’ category, ie first line unless alternative indicated. They are: T-Safe Cu 380Atm  OR new variants with copper bands sunk into the plastic frame, branded as TT 380 ‘Slimline’ or T-Safe Cu 380A  QL ‘Quick Load’ (available respectively from Durbin or FP Sales, see MIMS). These have a simpler loading system than the fiddly plastic ‘hat’ of older T-Safe Cu 380A.  It really is worth the effort to make this banded type of IUD one’s first choice, given the licence now for 10 years and the data supporting its effectiveness till 12 years, even when fitted below age 40. The main advantage is not its probable greater efficacy, see below –  above all in its latest form, with the copper bands near each tip of the T – but rather, the fact that research in the past 50 years has so clearly shown that most IUD complications can be (re-) insertion-related and they reduce in frequency with ↑duration of use. “Why ever use a 5-year device when a 10-year will fit?” It usually passes through the cervical canal surprisingly easily, in all parities.

NB: Nulliparity is not WHO 4!!  In a mutually monogamous relationship esp above age 30 it should be seen as only WHO 2, in some couples maybe 3, for the IUD method.  There is now a Mini TT 380 Slimline (Durbin) which is usefully smaller but still banded and with same area of Cu: making it usually the first-choice for nulliparae. However to negotiate a v tight internal Cx os, a non-banded IUD insertable through a finer tube may be needed (options below).

Duration of use: UK practice since 1990 is that ANY copper IUD fitted above age 40 can be used for the rest of reproductive life. Pre-medication with a NSAID should be routine for all insertions; and LA, injection of c 1 ml at

12 o’clock on the cervix, always offered.  I have never known a woman who gets that highly unpredictable, (sometimes unexpectedly severe), pain when the tenaculum is applied, not to appreciate this single small injection.

When to use others, eg Nova T380tm?  In a randomised controlled trial [14] the Nova T380 (aren’t the names confusing?!) which has copper wire but no bands, was significantly less effective than the T-Safe Cu 380A (cumulative failure rate at 3 years 3.6 vs 1.7 for the T-Safe). But it might well be appropriate (JG’s view) for a nulliparous woman using it for emergency contraception (EC) and planning to have the device removed once established on a new method, such as DMPA. Another possible EC option for nulliparae is the Flexi-T 300tm which is exceptionally small and has an easy push-in fitting technique with no separate plunger.  But it has been shown to have a highish expulsion rate and has no bands. For long term use in my view this and also the UT 380 Short (Nova T style but on a shorter stem, from Durbin) should usually be reserved for when the Mini TT 380 Slimline or other banded IUD cannot be fitted for some reason (eg cavity sounding to less than 6 cm). There is now also available the Flexi-T+380tm  with bands on its side arms, on a slightly enlarged frame but otherwise identical in shape. We need more data on this, sought but not so far forthcoming! It might be very effective and usable for longer than its 5 year licensed life; be as easily inserted as the Flexi-T 300; and have an acceptable expulsion rate. IF all that were true, being Cu-banded it might come to rival the T-Safe Cu 380A and all its clones, above. At present we lack the data to be sure.

When to use the banded GyneFixtm [15]? – NB not widely available, specific insertion training needed.  Useful in some cases. Special indications include a distorted cavity on ultrasound scan (if IUD useable at all), or a small uterus on sounding: <6 cm + no obvious lower limit. [The UT 380 Short or Flexi-T 300 are also for < 6cm but must be > 5 cm].   

Gynefix users should be forewarned about unrecognised expulsion: being able to feel the threads is crucial with this IUD.

[Note: the Multiloadstm are without any established advantages. Schering no longer market the ineffective Nova-T 200.]

 

Mirenatm IUS [16,17]

This is a major advance in contraceptive technology, with added value, relieving PAIN [16] with/without menorrhagia: facts still not widely enough appreciated!  But there are two more differences between Mirena and copper IUDs:

¨   It is NOT a method of EC.  Given this - and the importance of avoiding exposure of any fetus to v high local LNG in a conception cycle, using an anovulant method up to the insertion greatly helps logistics of insertion timing!

¨    It should normally be replaced at the licensed 5 years, or at 4 years if used with HRT, which is now licensed. 

When might the same IUS be left in longer?                                                                                                                       If fitted above age 45 and longer use is requested for contraception (NEVER as part of HRT), the NICE Guideline[11] permits sustained use, of the same IUS “until contraception no longer needed”, provided the woman “does not have periods with the IUS in place”.  BUT only on a named patient basis [2, 25] after well-documented counselling.                                         If only for menorrhagia or pain control, not contraception, the same IUS may of course be in situ for as long as it works.

Insertion:  Good training and attention to detail are crucial - as for all intrauterine methods. The Faculty of Family Planning’s norm for maintaining experience is a minimum of 12 insertions per year, of at least 2 types of IUD/IUS.

What about Mirena and EIDs? Walli Bounds of Margaret Pyke Centre showed maintenance of good effectiveness in 50 users of the IUS plus enzyme-inducers (one pregnancy reported) [11]. This is biologically plausible, since the LNG would still be released in high concentration locally, despite the EIDs, and should therefore have its normal effects on the utero-cervical fluid and also in impairing implantation. Therefore, pending more data, the use of Mirena by women on enzyme-inducers is a good choice, a WHO 2 situation (with advice that there might be a small diminution in its amazing efficacy).

PID riskNeither IUDs nor IUSs, intrinsically, increase PID risk. It is crucial to insert through a “Chinese cervix”!  This is a cervix established to be pathogen-free, so far as it can ever be [see pp 106-9 of ref [2]], by screening - verbally for mutual monogamy, PLUS usually (unless deemed unnecessary after good verbal screening), cervically for Chlamydia.

Past ectopic? Although anovulant methods would be even better, the IUS and banded IUDs[18] are options.

 

FEMALE STERILIZATION? - OR NEW-TYPE IUD? - OR the IUS? – efficacy is similar!

The Peterson et al study of 1996[19] showed the failure rate of female sterilization in the USA at that time to be 14/1000 at 7 years! – not different from the T-Safe Cu 380A and the IUS (14/1000 and 11/1000 failures respectively by 7 years); and there were no further failures at all with the copper IUD through to 10 years [16]. In UK the RCOG quotes the failure rate of the Filshie clip (NB not used in ref 19) as 2-3/1000, whereas it is 0.5/1000 for vasectomy after azoospermia[20].

 

EMERGENCY CONTRACEPTION

Currently the best oral method uses LNG alone as soon as possible after coitus [21-23].  There were 8 failures among 314 women (2.5%), treated with 1500 mg LNG  between 72 and 120 hours after a single coital exposure [24]. WHO concluded this is “prevention of a high proportion of pregnancies even up to 5 days after coitus”. However, other data suggest the prime mechanism that hormonal EC uses is to stop or delay ovulation and it probably rarely operates by implantation-block after fertilization.  Therefore, if the risk has probably been taken during the approx 5 days between fertilization and implantation, the most effective course is IUD insertion.  With that caveat, use of Levonelle 1500tm  up to 5 days after the exposure is acceptable as an example of unlicensed use of a licensed product[2,25] often termed Named patient’ use. For medico-legal safety, there should be a record that the woman understood this lack of licensing and gave informed verbal consent, ideally backed by a written handout to explain the difference(s) from the PIL, of Levonelle in this case.  She should also understand that a copper IUD would definitely be more effective [26],  usable in good faith for EC up to 5 days after the calculated day of ovulation, regardless of the number of unprotected sexual acts up to that time.

            Aside from current pregnancy the only absolute contraindications (WHO 4) to hormonal LNG-only EC are:

·        known severe  allergy (moderate/dubious allergy would be WHO 3) to a constituent and

·        known acute porphyria with previous attack(s)

Caution (WHO 3) also applies:

           

CONTRACEPTION FOR THE OLDER WOMAN [2,28]

Given that FSHs are unreliable for diagnosis of complete loss of ovarian function, contraception may cease:

 

But what to do if the woman uses one of the hormonal methods or HRT, which mask the menopause?

¨      A good guess is age 55 – the Faculty of FP, in their Guidance document [28], quote Treloar’s evidence that 95.9% have ceased menstruation for ever by then

¨      Guinness Book of Records reports one or two older mothers (into early 60s!) but authentication uncertain

All must report back if a period does happen, in which case a sponge or spermicide might be wisest for at least a while….         Another option for older users of COC or Patch, or of DMPA, IF:

1       they have passed 50, and, after a trial of discontinuation using barriers or spermicides, they have:

2       vasomotor symptoms (can usefully also ask ex COC-users if they had had flushes at end of each PFI) and

3       two separate high FSH levels one month apart and

4       the amenorrhoea continues beyond this trial period (reporting back if it doesn't)

With due warnings of lack of certainty, these women may cease all contraception earlier than the approved 1 year post 50.

The actual and expected advantages of HRT by LNG-IUS [nb change at 4 years] plus estrogen by any route

 

GLOSSARY, in order of mention:  COC combined oral contraceptive / UKMEC UK Medical Eligibility Criteria / WHOSPR WHO Selected Practice Recommendations / EID enzyme inducer drug / OR odds ratio = relative risk / Ca cancer / VTE venous thrombo-embolism / LNG levonorgestrel / NET norethisterone /              EE ethinylestradiol / CSM Committee on Safety of Medicines / DSG desogestrel / GSD gestodene / EC emergency contraception / PFI Pill-free interval / PMS premenstrual syndrome / PCOS  polycystic ovarian syndrome / BMI body mass index / POP progestogen-only pill / SPC Summary of Product Characteristics / DMPA depot medroxyprogesterone acetate /  IUD (IUS) intrauterine device (system) / Cx cervix / NSAID non-steroidal anti-inflammatory drug / LA local anaesthesia /PIL Patient Information Leaflet / INR International normalized ratio (test for anti-coagulation).

REFERENCES & FURTHER READING

1      Marchbanks P, McDonald J, Wilson H et al. Oral contraceptives and the risk of breast cancer. New Engl J Med 2002; 346:2025-32.

2      Guillebaud J. Contraception TodayA Pocketbook for General Practitioners (6th Ed) London: Informa healthcare, 2007, pp 23-33, 39-42, 68-72, 85-87, 98-100, 105-109, 113-17, 146-9, 150-1.

3      Moreno V, Bosch F, Munoz N et al. Effect of oral contraceptives on risk of cervical cancer in women with human papillomavirus infection: the IARC multicentric case-control study.  Lancet 2002; 359:1085-92.

4      Tanis, B, van den Bosch M, Kemmeren J.et al. Oral contraceptives and the risk of myocardial infarction. New Engl J Med 2002; 345:1787-1793

5      Dunn N, Thorogood M, Faragher B et al. Oral contraceptives and myocardial infarction: the results of the MICA case-control study. BMJ 1999; 319:795-6

6      Guillebaud J. Contraception: Your Questions Answered (4th Ed) Oxford: OUP, 2004, pp 199-212, 213-218, 535 and other pages expanding on those at ref [2].  

7      Beral V, Hermon C, Kay C et al. RCGP OC study. Mortality with oral contraceptive use: 25 year follow up…of 46 000 women.                  BMJ 1999;318:96-100.

8      Hannaford P, Webb, A. Evidence-guided prescribing of combined oral contraceptives: consensus statement. Contraception 1996; 54:125-9.

9      Miller L, Hughes J. Continuous Combination Oral Contraceptive Pills to Eliminate Withdrawal Bleeding: Randomized Trial. Obstet Gynecol 2003;101:653-661

   10     Edelman A, Koontz S,  Nichols M et al  Continuous Oral Contraceptives: Are Bleeding Patterns Dependent on the Hormones Given? Obstet Gynecol 2006;107:657-65

11    The effective and appropriate use of long-acting reversible contraception. National Institute for Health and Clinical Excellence. London: RCOG, October 2005.                                                                                                           

               http://www.nice.org.uk/pdf/CG030fullguideline.pdf

12    Implanon r , a new single rod contraceptive implant. Presentation of the clinical data. Contraception 1998; 58 (6-Supplement):75S-115S.

13    Weisberg E, Hickey M, Palmer D. Hum Reprod 2006;21:295-302

14    Haugan T, Skjeldestad F, Halvorsen L, Kahn H. A randomized trial on the clinical performance of Nova-T 380 and Gyne-T 380 Slimline copper IUDs.

              Contraception 2007;75:171-6.

15    Anon. Frameless intra-uterine contraceptive device (GyneFix). Drug and Ther Bulletin 2002;40(3):21-22

16    Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 mg/d and the TCu 380Ag IUDs: a multicenter study. Fertil Steril 1994;61:70-7.

17    Sturridge F, Guillebaud J. Gynaecological aspects of the LNG-releasing intrauterine contraceptive device (Review). Br J Obstet Gynaecol 1997; 104: 285-9.

18    Dennis J, Hampton, N. IUDs: which device? (Review). J Fam  Planning & Reprod Health Care 2002; 28: 61-68.

19    Peterson H B, Zhisen X, Hughes J M. et al. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization (CREST)                                                                              Am J of Obstet Gynecol 1996; 174: 1161-70

20    Male and female sterilization.  Evidence-based Guidelines No 4.  Royal College of Obs and Gynaecologists (RCOG): London, 2003.  See  < www.rcog.org.uk >

21    Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428-33

22    Guillebaud J. Time for emergency contraception with levonorgestrel alone. Lancet 1998;352:416-7.

23    Piaggio G, Von Hertzen H, Grimes D, van Look P. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999; 353: 721.

24    Von Hertzen H, Piaggio G, Ding J et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre    randomised trial. Lancet 2002; 360: 1803-10.

25    CEU of Faculty of FPRHC Guidance: Use of contraception outside terms of the product licence. J Fam  Planning & Reprod Health Care 2005;31:225-42.

26    CEU of Faculty of FPRHC Guidance: Emergency contraception.  J Fam  Planning & Reprod Health Care 2006;32:121-8.  Also at www.ffprhc..org.uk

27    Ellison J, Thomson A, Greer I. Apparent interaction between warfarin and levonorgestrel used for emergency contraception. BMJ 2000;321:1382.

28    CEU of Faculty of FPRHC Guidance: Contraception for women aged over 40 years. Journal of FP& RHC 2005;31:51-63

·      Cooper A, Guillebaud J. Sexuality and Disability. London: Radcliffe Medical Press, 1999.  [An often neglected  subject]

·      Kubba A, Sanfilippo J, Hampton N (eds). Contraception and Office Gynaecology: choices in reproductive healthcare.  London: Saunders, 1999.

·      McPherson A, Waller D (eds). Women’s Health – Oxford General Practice Series. Oxford: Oxford University Press, 2003.

 

JOHN GUILLEBAUD, Professor Emeritus of Family Planning and Reproductive Health, UCL                                                          January  2008