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Contraception Update. Contraceptive efficacy. Pearl Index Life Table Analysis Perfect use Typical use. Current use of contraception by age, 2005/6. www.ffprhc.org.uk www.fsrh.org.uk. LARC – NICE Guidelines. Contraceptive service providers should be aware that:
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ContraceptionUpdate August 2008
Contraceptive efficacy • Pearl Index • Life Table Analysis • Perfect use • Typical use
LARC – NICE Guidelines Contraceptive service providers should be aware that: • all currently available LARC methods (intrauterine devices [IUDs], the intrauterine system [IUS], • injectable contraceptives and implants) are more cost effective than the combined oral contraceptive pill even at 1 year of use • – IUDs, the IUS and implants are more cost effective than the injectable contraceptives • – increasing the uptake of LARC methods will reduce the numbers of unintended pregnancies
LARC includes: • Copper IUD • Progestogen-only IUS • Progestogen-only injectable • Progestogen-only subdermal implant • Combined vaginal rings
However Current LARC Usage is Low7 % 7. Schering Data on File, 2006, WOMEN AGED 16 TO 44
Accidental Pregnancy in First Year of Typical Use8 % of accidental pregnancy * Norplant and Norplant 2: Data is from USA where Implanon is not available 8 Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart R. Contraceptive Technology, ed 18. NY: Ardent Media, 2004
Discontinuation Rates of Contraceptive Methods1 % Discontinuation
UK Medical Eligibility Criteria • UKMEC1 No contraindication • UKMEC2 Benefits usually outweigh risks • UKMEC3 Risks usually outweigh benefits • UKMEC4 Contraindicated
Sterilisation • ‘Permanent’ but no longer the most effective • Can be reversed but no guarantee • Lifelong failure rate 5/1000 (i.e.10 times failure of vasectomy) • Requires invasive procedure
Types of Combined Contraception • 20, 30 or 35 micrograms of ethinyloestradiol • Different progestogens • 21 day and every day formulations • Fixed dose or phasic • Combined patch – Evra • 4 or 12 week withdrawal - Seasonale • Continuous pill • Combined Ring – Nuvaring
Hormonal contraception • Combined oestrogen and progestogen • Combined pill (COC) • Evra transdermal patch • Nuva-Ring vaginal ring
Combined methods • Advantages • Suppress ovulation • High efficacy • Give predictable ‘periods’ • Disadvantages • Increased risk of thrombosis • ?? Increased risk of breast cancer • (Increased risk of hepatocellular cancer)
Oestrogens Ethinyloestradiol Mestranol Progestogens Norethisterone Levonorgestrel Desogestrel Gestodene Norgestimate Drospirenone Cyproterone Constituents of COCs
Limitations on Dose Reduction • Loss of efficacy • Loss of cycle control (depends on both oestrogen and progestin) • Wide range of blood levels via oral route
Revised information from MCA May 99 • Third generation pills can be prescribed first-line • VTE risk in data sheets: 15 per 100,000 - second generation 25 per 100,000 - third generation
Breast cancer re-analysis 1996 - results • No effect of duration of use • No dose response • Cancers in pill users less advanced • Causal association unlikely • ? acceleration of tumour growth • ? surveillance bias
Cervical cancer risk factors Human Papillomavirus Smoking Oral contraceptives ?
Benefits of the COC (1) • Very effective, non-intercourse related contraception • Reduction in menstrual disorders ¯ functional ovarian cysts x 92% ¯ menorrhagia, irregular bleeding x 50% ¯ dysmenorrhoea x 40% ¯ PMS • ¯ Iron deficiency anaemia x 50% • ¯ PID x 50% • ¯ Ectopic pregnancy x 90%
Benefits of the COC (2) • ¯ Fibroids x 30% • ¯ Benign breast disease x 50 - 75% • Symptomatic relief / treatment of endometriosis • ? ¯ Duodenal ulcer • ¯ Rheumatoid arthritis x 50% • ¯ Endometrial cancer x 50% • ¯ Ovarian cancer x 40% • ¯ Colorectal cancer x 20%
Conception due to missed COCs • 'only' occurs if this leads to lengthening of the pill - free interval • NB - at either end
Missed pills – WHO Advice for COCS • Just keep going • Also if pill missed is in week 3 omit pill-free interval • Also backup or abstinence for 7 days if following number of pills missed - Two for twenty - Three for thirty
Lamotrigine (Lamictal) and the pill • Not an enzyme inducer • Interaction reduces levels of both agents • No evidence of reduced efficacy for COC • No evidence on POP
Why take a break ? • History • Tricycling • 25/3 may give better ovarian suppression • Continuous
EVRA: Simple administration schedule • 20 mcg ethinyloestradiol and 150 mcg norelgestromin • Apply weekly for 3 weeks • Apply same day-of-the-week • 1 week patch-free Sunday Sunday Sunday Sunday Sunday Patch-free Patch # 1 Start next cycle Patch # 2 Patch # 3 28-day cycle 28-day cycle Ref: Evra SmPC
EVRA Continuously Delivers EEWithin Reference Ranges 150 Evra Cilest 125 100 EE serum concentration (pg/mL) 75 Patch removed 50 25 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Days Adapted from Abrams Fertility and Sterility 2002
Dosing Reserve Results for ethinyl estradiol 100 80 Patch changed on schedule Patch removal delayed 60 EE serum concentration (pg/mL) Patch removed 3 days late 40 20 0 0 2 4 6 8 10 12 14 16 18 Days Ref: Abrams et al Fertility and Sterility 2002,
Evra – is a patch really better ? • Less variability in levels, but not a lower dose • Effects on SHBG similar or greater • ? Relevance of enzyme-inducers, antibiotics, etc • ? Thrombosis risk
New Delivery System:Vaginal Ring Progestin: Etonogestrel: 120 µg/day Estrogen: Ethinyl estradiol: 15 µg/day • Worn for three out of four weeks • Self insertion & removal • Pregnancy rate 0.65 per 100 woman–years Roumen FJ, et al. Hum Reprod. 2001;16(3):469-475.
Progestogen-only methods • Advantages • Greater safety • Variable efficacy (from extremely low to better than COC) • Some measure of loss of cycle control (varies with route, type and dose)
Routes available • Progestogen-only pill (POP) • Emergency contraception (Levonelle) • Injectable (Depo-Provera) • Intrauterine (Mirena) • Implant (Implanon)
Desogestrel POP (Cerazette) • 75 micrograms Desogestrel • Suppresses ovulation • Lower failure rate • Different rules for missed pills
Emergency Contraception • Products • Levonelle One Step • Any copper IUD, including GyneFix • Indications • Unprotected sex • Potential barrier failures • Potential pill failure • 2 missed pills in first week • 4 missed pills in mid-packet • Potential IUD failure • Increased risk of ectopic in failures • Awareness of risk may not translate into action
Levonelle One Step • 1500 micrograms levonorgestrel • Within 72 hours • Efficacy • < 24 hours 95 % • 24-48 hours 85 % • 49-72 hours 58 %
Emergency Hormonal Contraception (EHC) • Side effects • 23 % nausea • 6 % vomiting • Contraindications • Established pregnancy
Depo-Provera • 150 mg medroxyprogesterone acetate • IM • Every 12 weeks • Failure rate approx 0.5% • High incidence of amenorrhoea • Long-term use associated with reduced bone density which recovers with addback or discontinuation
Fertility awareness • Depends on abstinence • Requires high degree of motivation • Failure rates high especially in new users • Based on a number of false premises about fertility, therefore relatively high method failure rate as well as high user failure
IUD (Copper devices) • Gold standard Copper T 380 • Not user-dependant • Good efficacy (failure rate 1% or less p.a.) • Requires insertion and removal • Some increased risk of infection in first 60 days especially when cervix colonised • Periods may be heavier, longer, more painful
Intrauterine • Mirena releases 20 mcg levonorgestrel daily for 5 years • Failure rate equal to or less than female sterilisation • Reduction in menstrual loss a beneficial side-effect
Good contraception Control of menorrhagia May help dysmenorrhoea Effective endometrial protection Some systemic absorption Irregular bleeding may persist Insertion not always easy Mirena
Implanon • Subdermal • Etonogestrel • Menstrual irregularity common • Failure rate far below that of sterilisation
Rate-controlling membrane (0.06 mm) 2 mm Core 40 mm Core: 40% EVA 60% etonogestrel Membrane: 100% EVA The design of Implanon®Progestogen only contraceptive
Implanon® Mode of action • Ovulation inhibition : primary effect • Effect on cervical mucus: secondary effect