Basics of hormonal contraception aurangabad
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This document discusses various methods of hormonal contraception, including combined oral contraceptives (COCs), the contraceptive patch, vaginal ring, and progestin-only methods. It covers the mechanisms of action, effectiveness rates, benefits and risks of different formulations. COCs are the most commonly used method worldwide. The contraceptive patch and vaginal ring provide alternatives to pills with similar efficacy but convenience of weekly or monthly dosing. Progestin-only options include the progestin-only pill, injectables like DMPA, and long-acting reversible implants.
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Basics of hormonal contraception aurangabad
- 1. Basics of HormonalBasics of Hormonal ContraceptionContraception Dr varsha deshmukhDr varsha deshmukh Ass profAss prof GMC, AURANGABADGMC, AURANGABAD
- 2. ObjectivesObjectives Discuss the available methods of hormonalDiscuss the available methods of hormonal contraception.contraception. Discuss efficacy, contraindications, andDiscuss efficacy, contraindications, and instructions for use.instructions for use. Explain different methods for reporting contraceptive failure rate. Reading: Contraceptive Technology 18Reading: Contraceptive Technology 18thth ed.ed. 391-494391-494
- 3. Categories ofCategories of ContraceptivesContraceptives E+P COCs Transdermal Patch Vaginal Ring P only POP DMPA LNG-IUS Implants No hormones CuT IUD Barrier Surgical NFP
- 4. ContraceptiveContraceptive effectivenesseffectiveness Pearl indexPearl index Life-tableLife-table
- 5. Pearl IndexPearl Index Number of pregnancies x 1300 NuPearl IndexPearl Indexmber of cycles
- 6. Pregnancy Rate (%) During 1Pregnancy Rate (%) During 1stst Year of UseYear of Use Hatcher: Contraceptive Technology, 18th Ed % of Women Experiencing% of Women Experiencing an Unintended Pregnancyan Unintended Pregnancy within the First Year of Usewithin the First Year of Use % of Women% of Women ContinuingContinuing Use at OneUse at One YearYear MethodMethod Typical UseTypical Use PerfectPerfect UseUse No MethodNo Method 8585 8585 4242 Male CondomMale Condom 1515 22 5353 Combined Pill and POPCombined Pill and POP 88 0.30.3 6868 Ortho Evra PatchOrtho Evra Patch 88 0.30.3 6868 Vaginal RingVaginal Ring 88 0.30.3 6868 DMPADMPA 33 0.30.3 5656 copper T IUDcopper T IUD 0.80.8 0.60.6 7878 levonorgestrel IUSlevonorgestrel IUS 0.10.1 0.10.1 8181 Female SterilizationFemale Sterilization 0.50.5 0.50.5 100100 Male SterilizationMale Sterilization 0.150.15 0.100.10 100100
- 7. Combined OralCombined Oral ContraceptionContraception Mechanism of actionMechanism of action Non-contraceptive benefitsNon-contraceptive benefits Indications/contraindicationsIndications/contraindications Counseling on use, startCounseling on use, start History of the pillHistory of the pill
- 8. COCsCOCs 80% of US women born after 1945 have80% of US women born after 1945 have used OCs at some time.used OCs at some time. Introduced 1960Introduced 1960 – 11stst , 2, 2nd,nd, 33rdrd generation pillsgeneration pills – Varying progestin componentVarying progestin component failure ratefailure rate – 0.3%, perfect use0.3%, perfect use – 8% typical first-year use8% typical first-year use Effective, safe, rapidly reversible form ofEffective, safe, rapidly reversible form of contraceptioncontraception
- 9. Mechanism of actionMechanism of action Mostly aMostly a progestinprogestin effecteffect – Block LH surge, inhibiting ovulation. (breakthroughBlock LH surge, inhibiting ovulation. (breakthrough ovulation rate 2-8% depending on EE dose)ovulation rate 2-8% depending on EE dose) – Thicken cervical mucusThicken cervical mucus – Inhibit capacitation of spermInhibit capacitation of sperm – Slow tubal motilitySlow tubal motility – Distrupt transport of fertilized ovumDistrupt transport of fertilized ovum – Endometrial changes (atrophy, underlying vascularEndometrial changes (atrophy, underlying vascular function and structure and alter the metalloprotein content)function and structure and alter the metalloprotein content) Estrogen (ethinyl estradiol or mestranol) – Cycle control – acts to inhibit follicular growth by decreasing FSH
- 10. PharmacologyPharmacology Progestins 19-nortestosterone Estranes Gonanes Norethindrone Norethindrone Acetate Ethynodiol diacetate
- 12. PharmacologyPharmacology Progestins 19-nortestosterone Estranes Gonanes Norethindrone Norethindrone Acetate Ethynodiol diacetate Norgestrel* Gestodene Desogestrel Norgestimate 17α-acetoxyprogesterone Pregnanes MegaceMPA
- 13. PharmacologyPharmacology Progestins 19-nortestosterone Estranes Gonanes Norethindrone Norethindrone Acetate Ethynodiol diacetate Norgestrel* Gestodene Desogestrel Norgestimate 17α-spironolactone Drospirenone 17α-acetoxyprogesterone Pregnanes MegaceMPA
- 14. Metabolic Effects of Estrogen and ProgestinMetabolic Effects of Estrogen and Progestin EstrogenEstrogen ProgestinProgestin ProteinProtein ↑↑ Globulin synthesis*Globulin synthesis* ↓↓ SHBGSHBG LipidsLipids HDL cholesterolHDL cholesterol ↑↑ ↓↓ LDL cholesterolLDL cholesterol ↓↓ ↑↑ Total cholesterolTotal cholesterol ↑↑ ↓↓ TriglyceridesTriglycerides ↑↑ ↓↓ * Including many clotting factors, angiotensinogen, and SHBG* Including many clotting factors, angiotensinogen, and SHBG
- 15. Other benefits- gynOther benefits- gyn ImprovesImproves – dysmenorrheadysmenorrhea – menstrual blood lossmenstrual blood loss – PMSPMS – fibroidsfibroids – anovulatory bleedinganovulatory bleeding – Mittelschmerz painMittelschmerz pain – Ovarian cystsOvarian cysts – menstrual migrainesmenstrual migraines – Androgen sensitivity/excess conditionsAndrogen sensitivity/excess conditions – PID severityPID severity – EndometriosisEndometriosis – AnemiaAnemia Decreased risk uterine/ovarian cancerDecreased risk uterine/ovarian cancer Decreased risk benign breast conditionsDecreased risk benign breast conditions
- 16. Other benefits – non-gynOther benefits – non-gyn Possible decrease risk of rheumatoidPossible decrease risk of rheumatoid arthritisarthritis Increased bone mineral density.Increased bone mineral density. LipidsLipids Possible decrease colorectal cancerPossible decrease colorectal cancer risk,risk, seizure, asthma, (when related toseizure, asthma, (when related to menses)menses)
- 17. DisadvantagesDisadvantages General:General: – Daily useDaily use – expenseexpense – storagestorage – no STI protectionno STI protection
- 18. Health complicationsHealth complications with COCswith COCs Myocardial Infarction (MI)Myocardial Infarction (MI) StrokeStroke Venous Thromboembolism (VTE)Venous Thromboembolism (VTE) HypertensionHypertension
- 19. Health complicationsHealth complications with COCswith COCs MIMI – arterial thrombosisarterial thrombosis – Low-dose (<50mcg EE) has no significantLow-dose (<50mcg EE) has no significant increase in risk in healthy women – 1.3increase in risk in healthy women – 1.3 – Role of other risk factorsRole of other risk factors Smoking (75% attributable)Smoking (75% attributable) Underlying atherosclerotic CVDUnderlying atherosclerotic CVD AgeAge
- 20. Health complicationsHealth complications with COCs (cont)with COCs (cont) StrokeStroke – No increase in low risk womenNo increase in low risk women – High risk =High risk = Migraine with aura (OR 3.0)Migraine with aura (OR 3.0) Smokers (RR 7.6)Smokers (RR 7.6) HTN (RR 25.7)HTN (RR 25.7)
- 21. Health complicationsHealth complications with COCs (cont)with COCs (cont) VTEVTE – Estrogen increases liver production of variousEstrogen increases liver production of various clotting factors and platelet activityclotting factors and platelet activity – Rate per 100,000:Rate per 100,000: Baseline: 4-5Baseline: 4-5 Low-dose OC: 12 – 20Low-dose OC: 12 – 20 Pregnancy: 40 – 60Pregnancy: 40 – 60 – Significant increases most common with riskSignificant increases most common with risk factors: thrombophiliafactors: thrombophilia
- 22. Health complicationsHealth complications with COCs (cont)with COCs (cont) HypertensionHypertension – Increase angiotensin IIIncrease angiotensin II – E and P enhance aldosterone activity ->E and P enhance aldosterone activity -> fluid retention and increased BPfluid retention and increased BP – 3-5mm rise common3-5mm rise common – Should normalize after discontinuation. IfShould normalize after discontinuation. If not, HTN workup warranted.not, HTN workup warranted.
- 23. Health ComplicationsHealth Complications with COCswith COCs Slight increases inSlight increases in – Benign liver tumorsBenign liver tumors – Chlamydia cervicitisChlamydia cervicitis – Cervical dysplasiaCervical dysplasia
- 24. Health ComplicationsHealth Complications with COCs (cont)with COCs (cont) Do NOT increase:Do NOT increase: – Glucose metabolism/DiabetesGlucose metabolism/Diabetes – Gallbladder disease unless preexistingGallbladder disease unless preexisting – Choestatic jaundiceChoestatic jaundice – Hepatic carcinomaHepatic carcinoma Probably do not increase:Probably do not increase: – Breast cancerBreast cancer
- 25. AbsoluteAbsolute contraindicationscontraindications Breastfeeding < 6wk ppBreastfeeding < 6wk pp Smoke > 15 cig/day; >35 yoSmoke > 15 cig/day; >35 yo Uncontrolled HTNUncontrolled HTN History of DVT/PEHistory of DVT/PE ThrombophiliaThrombophilia Heart disease, MI, CVAHeart disease, MI, CVA Migraine with auraMigraine with aura Breast cancerBreast cancer
- 26. Pill initiation methodsPill initiation methods Quick-startQuick-start – Day of visitDay of visit – Reasonably sure not pregnantReasonably sure not pregnant – 7 days back-up7 days back-up – Remind that menses may be delayed or irregularRemind that menses may be delayed or irregular – More successful at getting women started on the pills.More successful at getting women started on the pills. First-day startFirst-day start – In regularly ovulating, normal mensesIn regularly ovulating, normal menses Sunday startSunday start – Back up needed for 7 days.Back up needed for 7 days. – Not usually recommended.Not usually recommended.
- 27. Patterns of Pill usePatterns of Pill use Monthly cycling 21/7Monthly cycling 21/7 Multiphasic PreparationsMultiphasic Preparations – Alters the dosage of both the estrogen andAlters the dosage of both the estrogen and progestin components periodically throughout theprogestin components periodically throughout the pill-taking schedulepill-taking schedule Reduction in pill-free intervalsReduction in pill-free intervals – Using a 4-day pill-free interval is associated withUsing a 4-day pill-free interval is associated with greater ovarian suppression.greater ovarian suppression. Extended cycle regimens (bicycling, tricycling)Extended cycle regimens (bicycling, tricycling) – 42 – 84 active followed by 7 inactive pills42 – 84 active followed by 7 inactive pills – Seasonale, SeasoniqueSeasonale, Seasonique Continuous useContinuous use
- 28. Transdermal ContraceptiveTransdermal Contraceptive PatchPatch Ortho-McNeil Pharmaceutical 2001
- 29. TransdermalTransdermal Contraceptive PatchContraceptive Patch Advantages:Advantages: – Similar indication profile as COCs.Similar indication profile as COCs. – Similar non-contraceptive benefitsSimilar non-contraceptive benefits – Once-weekly dosingOnce-weekly dosing – VisibleVisible DisadvantagesDisadvantages – VisibleVisible – Similar to COCSimilar to COC – No STI protectionNo STI protection – Local skin irritationLocal skin irritation
- 30. Patch and VTE?Patch and VTE? Hype: “Hype: “Birth control patch linked to higherBirth control patch linked to higher fatality ratefatality rate”-Associated Press July 20, 2005”-Associated Press July 20, 2005 Findings:Findings: – 2/3 case-control studies do not show increased2/3 case-control studies do not show increased risk in patch users vs. pill usersrisk in patch users vs. pill users – 1 study that does show risk has selection bias. All1 study that does show risk has selection bias. All patch users were new users, pill users could bepatch users were new users, pill users could be continuing userscontinuing users Jick, S Contraception 2007; 76:4-7 Jick, S Contraception 2006; 73: 223-226 Cole, J Obstetrics and Gynecology 2007; 9(1):339-346
- 31. Van den Heuvel et al, Contraception. 2005 72(3) 168-74.
- 32. Contraceptive Vaginal RingContraceptive Vaginal Ring www.contraceptiononline.com
- 33. Vaginal ContraceptiveVaginal Contraceptive RingRing – 0.12mg/day etonogestrel (the metabolite of desogestrel)0.12mg/day etonogestrel (the metabolite of desogestrel) – 1515 µµg/day ethinyl-estradiolg/day ethinyl-estradiol 3 weeks in /1 week ring-free3 weeks in /1 week ring-free less BTB than OCsless BTB than OCs AdvantagesAdvantages – rapid return to ovulationrapid return to ovulation – lower doses of hormones,lower doses of hormones, – ease and convenience,ease and convenience, – improved cycle control.improved cycle control. Same contraindications as OCsSame contraindications as OCs
- 34. Progestin-onlyProgestin-only contraceptioncontraception Describe the advantages and limitations ofDescribe the advantages and limitations of progestin only contraception.progestin only contraception. List the administration methods of progestinList the administration methods of progestin only contraception.only contraception. Discuss the factors relevant to prescribingDiscuss the factors relevant to prescribing injectable progestin only contraception.injectable progestin only contraception. Describe the Implanon contraceptive deviceDescribe the Implanon contraceptive device and for whom it is appropriate.and for whom it is appropriate.
- 35. Progestin OnlyProgestin Only ContraceptivesContraceptives Oral pillOral pill 19731973 Injectable suspensionInjectable suspension IntramuscularIntramuscular 1968 (1992 U.S.)1968 (1992 U.S.) SubcutaneousSubcutaneous 20052005 Subdermal ImplantSubdermal Implant 6 LNG6 LNG 19901990 2 LNG2 LNG 19961996 1 ENG1 ENG 2001 (2006 U.S)2001 (2006 U.S) Intrauterine System (LNG)Intrauterine System (LNG) 20022002
- 36. Mechanism of ActionMechanism of Action Ovulation inhibition by decreasedOvulation inhibition by decreased GnRH pulse frequency.GnRH pulse frequency. Suppression of midcycle LH and FSHSuppression of midcycle LH and FSH surgesurge Thickened and decreased cervicalThickened and decreased cervical mucusmucus Endometrial changes (atrophicEndometrial changes (atrophic endometrium)endometrium)
- 37. Progestin-only PillsProgestin-only Pills NorethindroneNorethindrone – MicronorMicronor – Nor-QDNor-QD NorgestrelNorgestrel – OvretteOvrette Slightly less effective than COCSlightly less effective than COC Highly sensitive to user errorHighly sensitive to user error
- 38. Depot MedroxyprogesteroneDepot Medroxyprogesterone AcetateAcetate 150 mg intramuscular q 3 mos150 mg intramuscular q 3 mos – DeltoidDeltoid – GlutealGluteal 104mg subcutaneous q 3 mos104mg subcutaneous q 3 mos Contraceptive level of progesteroneContraceptive level of progesterone maintained for 14 weeksmaintained for 14 weeks DMPA is not a “sustained-release” systemDMPA is not a “sustained-release” system – Relies on high peaks of progestin toRelies on high peaks of progestin to inhibit ovulation and thicken mucusinhibit ovulation and thicken mucus
- 39. DMPA - ? disadvantagesDMPA - ? disadvantages 6-9 month delay in return to fertility6-9 month delay in return to fertility Weight gainWeight gain – Normal weight women do not haveNormal weight women do not have increased weight gainincreased weight gain – MPA stimulates appetiteMPA stimulates appetite Bone lossBone loss – similar to lactationsimilar to lactation – reversiblereversible – smoking may be a risk factor.smoking may be a risk factor. – No evidence for increased fracture riskNo evidence for increased fracture risk
- 40. ImplanonImplanon 3-year implant3-year implant 68 mg etonorgestrel68 mg etonorgestrel Highly effectiveHighly effective Irregular menstrual profileIrregular menstrual profile Endogenous estrogenEndogenous estrogen present, bones protectedpresent, bones protected Easier removal thanEasier removal than NorplantNorplant Requires provider trainingRequires provider training www.implanon-usa.com
Editor's Notes
- By the end of this talk, you should be able to Discuss the available methods of hormonal contraception. Discuss efficacy, contraindications, and instructions for use. Explain different methods for reporting contraceptive failure rate. And here is the suggested reading.
- Ok… this is going to be an interactive session. So we’ll start with something easy. I’m going to go around the room and each person is going to tell me a different method of contraception….
- Before we can talk about the different types of contraceptives, we need to know HOW to talk about birth control. We can usually refer to measures of contraceptive efficacy. Does anyone know what they are?
- Pearl Index is one of the most commonly used methods for reporting contraceptive efficacy, and is the standard for package inserts and what the FDA wants to know. Does anyone have an idea of what might be the problem with this? What it doesn’t take into account is that efficacy improves over time as the women for whom it wasn’t working drop out of the equation over time.
- Perhaps a better way of explaining this is with life-table analysis, which is summarized for the common forms of contraception as number of pregnancies per 100 in the first year of use.
- Now I wanted to move into combined oral contraception. We’ll talk a little bit about the History of the pill Mechanism of action Non-contraceptive benefits Indications/contraindications Counseling on use, start
- One of the most common forms of contraception used by US women. The pill was initially introduced for contraception in 1960. the initial pills, or first generation, contained 50mcg EE or mestranol and had varying progestin components. Over time, we’ve been able to decrease the side effects of estrogen (nausea, breast tenderness, and increased venous thrombosis) by decreasing the EE dose, with 35 mcg or less of EE considered a “low-dose” pill and this is primarily what we use today. 3rd generation? Those with the progestin gestodene/desogestrel because they have greater progestational activity. Overall, these are effective, safe, rapidly reversible contraception.
- So how do COCs work? So 50/50, which component of the COC is responsible? The main action of combined steroid contraceptives comes from the progestational agent which suppresses LH secretion (prevents ovulation) while Estrogenic agent suppresses FSH secretion (prevents the selection and emergence of a dominant follicle) However, even if follicular growth and development were not sufficiently inhibited, the progestational component would prevent the surge-like release of LH necessary for ovulation The progestational agent takes precedence over estrogen: so endometrium, cervical mucus, and tubal function reflect prog stimulation Estrogens are included primarily to provide better cycle control, and were included somewhat accidentally in the first pills as they were a by-product of the progestin synthesis. Estrogen stabilizes endometrium so that irregular shedding and unwanted breakthrough bleeding can be minimized and the presence of estrogen is needed to potentiate action of progestational agent
- So let’s step back to think a little bit about the different progestins in COCs. Most of the common progestins in COCs are derivatives of 19-nortestosterone in one of two categories, either estrane or gonane. The estrane category gives you variations on Norethindrone including norethindrone acetate and ethynodiol diacetate. The activity of these progestins are due to rapid conversion to the norethindrone.
- The gonanes include Norgestrel and it’s derivatives. Keep in mind with norgestrel that it is a mixture of a levorotatory and dextrorotatory enantiomer. They are mirror images of one another dl-norgestrel. Levonorgestrel is the active isomer of norgestrel. The other progestins in this group are variations on the structure of lng. You can see that just small variations create new compounds with different biological activity. Removal of the methyl group of lng gives you norethindrone. All of these testosterone-derived progestins bind to the androgen receptor and have some residual androgenic activity. The newer progestins have some structural modifications that lower their androgen activity. Norgestimate, desogestrel are the least androgenic compounds. Gestodene is not available in the U.S. The affinity for the androgen receptor is low and they have little effect on SHBG
- A second group of progestins became available for use when it was discovered that acetylation of the 17-hydroxy group of 17-hydroxy progesterone produced an orally active but weak progestin. An addition at the 6 position is necessary to give sufficient progestational strength for human use. Derivatives of this group of progestin are MPA and megace.
- So, a quick overview of progestin pharmacology – there are many synthetic progestins used in contraceptives, but briefly they can be broken down in to three big groups – derivatives of 17 alpha acetoxyprogesterone, 19 nortestosterone and 17alpha spironolactone. The first groups give the pregnanes, which have high progestin activity and are used to make MPA and megace. Most of the OCs use a progestin from the 2nd group. The estranes give you norethindrone and its derivatives and the gonanes give you norgestrel and its derivatives. Some what different is drospirenone, a spironolactone derivative which has slightly different properties – both antiantrogenic (acne) and antimineralocoricoid activity, which helps with bloating/fluid retention Drospirenone is a progestin that is an analogue of spironolactone. It’s biochemical profile is very similar to progesterone, including a high affinity for the mineralocorticoid receptor. This binding leads to natriuresis. In normal women there is a compensatory activation of the RAS system with increase in aldosterone production and there ends up being no overall increase in K+ retention, but Caution should be used in women at risk for hyperkalemia due to drospirenone’s potassium sparing effects Drospirenone has progestogenic, antiandrogenic, and antimineralocorticoid activity. Yasmin is the first contraceptive to contain DRSP. Antimineralocorticoid: Prevents estrogen-related bloating and fluid retention Antiandrogenic: Reduces severity of acne, seborrhea, related skin conditions
- So here’s a favorite CREOG point: How do OC’s affect metabolism What does it do to protein metabolism: Estrogen increases globulin synth, including SHBG, helping with its antiandrogenic effect. This is somewhat counted by progestin, but overall there is an increase. As for lipids, what happens? Increased hdl, decreased ldl, again minimized by progestin effect (especially with the more androgenic progestins), but the overall effect is favorable. Overall, there is a slight increase in triglycerides, but clinically not significant. However, women with elevated TG shouldn’t use as it may push them to a level high enough to be significant (pancreatitis is the primary concern).
- So what are some of the other gynecologic benefits of OCs? So there are lots and we’d be here all day if I went into the details of each and I’m sure you know most of them so … Decreases dysmenorrhea avg of 60%, and severe dysmenorrhea 90%, which is even more improved with continuous or extended use, and results in fewer absences from school and work
- How about some of the non-gyn benefits? -
- So what are some of the cons of coc’s?
- We’ll have another lecture later in the year which goes much more into depth for women with medical conditions, but just to summarize: There are some people who should never use COCs: -
- Multiphasic prepartions. The aim is to alter steroid levels in an effort to achieve lesser metabolic effects and minimize the occurrence of breakthrough bleeding and amenorrhea, while maintaining efficacy. Metabolic studies indicate no differences or slight improvements over low dose monophasic products. Reduction in pill-free interval is a strategy aimed at the concern that pill omission with low-dose OCs might result in “escape” ovulation. The FDA recently approved Yaz: drsp3mg/20mcgee and Loestrin24-4 1mgnorethindrone acetate/20mcgee. It is hoped that contraceptive failures and side effects will be minimized with the 24-4 approach. However the failure rates and breakthrough bleeding rates have been shown to be comparable to the stand 7-day pill free interval regimens. Extended cycle regimens: Seasonale was FDA approved in 2003 with 0.15mglng/30mcgee in 84 active pills and 7 days of placebo. The FDA recently approved Seasonique 0.15mglng/30mcgee with 7 days of 10mcgee instead of placebo. Break through bleeding is a common problem with extended cycle Ocs but does not represent a decrease in contraceptive efficacy.
- Another combined hormonal contraceptive method is the transdermal contraceptive patch. It has the convenience of weekly dosing Continuous delivery of hormone to systemic circulation It also has the advantage of bypassing the GI tract and 1st pass metabolism
- So there’s been a lot of talk about the patch and VTE risk and a lot of hype to go with it. This comes from studies that initially showed that when the pharmacokinetics of the patch, ring, and pill were compared, the patch had a 60% greater AUC than the pill of EE levels, even though the pill had higher peak levels. Subsequent studies have tried to tease out the clinical significance of these findings. Jick, S Contraception 2007; 76:4-7 Jick, S Contraception 2006; 73: 223-226 Cole, J Obstetrics and Gynecology 2007; 9(1):339-346 ARHP Patch Talking Points * The patch has been used by approximately four million women in the United States since it became available in 2002. * Deaths among young women because of medical problems such as heart attack are very rare, and they are also very rare among young women using contraceptive hormones. * Taking oral contraceptives or using hormonal contraceptive patches slightly increases the risk of cardiovascular problems—especially for women over 35 who smoke. * The rate for cardiovascular problems estimated for women using the patch is in the range that has been reported for other hormonal contraceptives such as oral contraceptives [see Contraceptive Technology Table 9-4, p. 230]. * Health risks for patch users are essentially the same as risks for women using other hormonal contraceptives. * In context, risks for death associated with other common activities such as driving an automobile (1 in 5,900) or continuing a pregnancy to term (1 in 10,000) are significantly higher than risks associated with use of hormonal contraceptives. * The risk of death associated with pregnancy—a common outcome among women who don’t use contraception—is far higher than the risk of death associated with using contraceptive pills or the patch. Pregnancy-related deaths, including those at delivery, stillbirth, and ectopic pregnancy, claim the lives of two to three U.S. women every day—with 13 deaths reported for every 100,000 live births in 1999. * Possible adverse drug reports are submitted voluntarily to FDA by clinicians in the U.S. and are intended to provide a means to identify rare medical problems that had not been anticipated in the clinical studies undertaken for FDA drug approval. Serious medical events are reported whether or not there is a clear &quot;cause and effect&quot; connection to the drug. For any medication that is widely used, therefore, at least some deaths are bound to occur and be reported.
- Very low dose (lower than OC) 0.12mg/day etonogestrel (the metabolite of desogestrel formerly known as 3-keto-desogestrel) 15 g/day ethinyl-estradiol One ring per cycle:3 weeks in /1 week ring-free Excellent bleeding patterns (less BTB than OCs) Advantages of this method include rapid return to ovulation after discontinuation, lower doses of hormones, ease and convenience, and improved cycle control. Same contraindications as OCs
- Progestin only contraception comes in many different forms. The first available in the US was the pop or mini-pill. Dmpa has been around internationally since 1968 but was only approved for use in the US in 1992. the sq form was developed and approved for use in 2005. Subdermal implants, first norplant which was a 6 rod system, then jadelle a 2 rod system that is not currently available in the us, and now implanon a 3 year etonorgestrel system (same progestin as the vaginal ring) . The lng ius also counts as progestin only contraception but we’ll save that for the IUD workshop we’re doing for you in february.
- To review, how does progestin only contraception prevent pregnancy: All have similar mechanisms of action, similar to the progestin activity with the combined methods that we talked about earlier.
- Slightly less effective than COC with typical use failure rate of 8% in the first year. Perfect use = 0.3%. Highly sensitive to user error (serum levels drop to subtherapeutic levels within 24 hrs) Gonadotropins not completely suppressed: approx 40-50% of patients will ovulate normally. Maintains cervical mucus thickness for approximately 22 hours; thereafter the mucus thins and by 24 hours is unable to prevent sperm penetration Associated with more breakthrough bleeding and slightly higher failure rates than combined Ocs. Also called the minipill, it must be taken at the same time each day and every day without a pill free interval. Variation of only a few hours can reduce contraceptive effectiveness so women should use a back-up method if there is greater than a 3 hour delay in taking the pill.
- Ideally the first injection of DMPA is given within 5 days after the onset of menses in which case alternative contraception is not necessary. The same dose is repeated at 12 week intervals. Ovulation is suppressed for 14 weeks so delay in administering subsequent doses of up to 2 weeks should not reduce contaceptive efficacy.
- Most women have return to fertility in 6-9 months after the time the next injection would have been given but can be delayed up to 18 months after stopping DMPA. So this mode of contraception is not ideal for women who may wish to become pregnant soon after stopping contraception. Controlled prospective studies evaluating weight gain in normal weight women showed no relationship between DMPA use and change in weight. However, obese adolescents using DMPA gained significantly more weight than obese girls starting Ocs or non hormonal contraception. There is inconclusive data on the relationship of DMPA with depression. Prospective studies suggest no causal effect. DMPA associated loss of bone mineral density may be prevented by estrogen supplementation. The bone loss is reversible after DMPA is discontinued. FDA black box warning. WHO states there should be no restrictionon the use of DMPA among women 18-45. In adolescents and women over 45 the advantages of DMPA generally outweight the theoretical safety concerns regarding fracture risk, but since the data are insufficient in these age groups to determine the risks of long term use, the overall risks and benefits fro continuing the use of the methould should be reconsidered over time with the individual user. In one study, dmpa use was associated with a 3.1% decrease in lumbar bone mineral density after 2 years among teens. Unknown to what extent bone density is regained but benefits usually outweight risks (category 2). Calcium intake and exercise need to be addressed with each dmpa user.
- Non-biodegradable, single rod implant for subdermal use 4cm long, 2mm wide Contains 68 mg Etonogestrel in an ethylene vinylacetate (EVA) copolymer core, surrounded by a skin with the same material Irregular menstrual profile No pregnancies in the first 70,000 cycles studied in which the device was inserted properly. No tissue fibrosis like the silastin in Norplant This releases more progesterone than the lng IUS which releases 20mcg/day and lng IUS is more effective than female sterilization. Clinical trials involved 923 subgects with 20,648 cycle exposures. There were no pregnancies on Implanon. There were 6 pregnancies reported and these occurred after removal of the implant. Providers will not be able to prescribe Implanon until they have been trained on insertion. As with other progestin only formulations, unscheduled bleeding is a major cause for discontinuation.These women will not become amenorrheic because endogenous estrogen levels are not suppressed. The bones are protected.