Contraception in the Community Adapted by Jill Gallin, CPNP Assistant Professor of Clinical Nursing U.S. Pregnancies: Unintended vs. Intended Intended 51% Unintended 49%: Unintended births (22.5%) Elective abortions (26.5%) Henshaw SK. Fam Plann Perspect. 1998;30:24-29. www.contraceptiononline.org Adolescents Who Have Had Intercourse 100 1970 90 1975 1980 1985 1988 1995 80 Percent 70 60 50 40 30 20 10 0 15 16 17 18 19 All Age (y) National Surveys of Family Growth. 1970, 1975, 1980, 1985, 1988, and 1995. www.contraceptiononline.org The Need for Contraception Unintended Pregnancies (%) by Age 100 Percent 80 60 40 20 0 15-19 20-24 25-29 30-34 Age (y) 35-39 40+ Henshaw SK. Fam Plann Perspect. 1998;30:24-29, 46. www.contraceptiononline.org The Need for Contraception Pregnancies Ending in Abortion by Age 50 40 30 20 10 0 15-19 20-24 25-29 30-34 35-39 40+ Age (y) *Does not include miscarriages. Henshaw SK. Fam Plann Perspect. 1998;30:24-29, 46. www.contraceptiononline.org Adolescent Pregnancy Pregnancies/1,000 19 y* An International Perspective—Developed Countries 100 80 Abortions 44 60 22 40 20 0 Births 26 15 53 49 44 32 19 27 13 32 16 24 22 18 24 11 15 16 12 9 4 6 6 4 *1988. Reproduced with permission from The Alan Guttmacher Institute. Sex and America’s Teenagers, 1994. www.contraceptiononline.org Adolescents Delay Seeking Medical Contraceptive Services Made no visit 31% Before/same month 12% 1 y or more after 29% 7-12 months after 12% 4-6 months after 1-3 months after 5% 11% Alan Guttmacher Institute. Sex and America's Teenagers,1994 www.contraceptiononline.org FDA Advisory Committee’s Recommendation on Delay of Pelvic Exam “Physical examination may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician.” FDA Advisory Committee Recommendation. www.contraceptiononline.org Adolescents’ Contraception at First Intercourse Other 1% OCs 8% No method 35% Withdrawl 13% Withdrawl 4% Condom 61% Other 1% Condom 48% Withdrawl 8% No method 52% 1995 OCs 8% Other 4% No method 23% OCs 11% Condom 23% 1988 1982 National Surveys of Family Growth, 1992, 1988, and 1995. www.contraceptiononline.org Method Use, Last Intercourse Young Women, 14 to 22 years old 60 14-15 16 17 18 19 20 21-22 ALL 50 40 30 20 10 0 nly o l l Pi do n o C nly o m om om om d d d n n n co co /co l d d a n n a a aw r r e d Pill h h Ot Wit Santelli JS et al. Fam Plann Perspect. 1997;29:261-267. N on e www.contraceptiononline.org Properties of Contraceptives Desired by Women Highly effective Prolonged duration of action Rapidly reversible Privacy of use Protection against STD Easily accessible www.contraceptiononline.org Optimizing Patient Choices Effectiveness Theoretical Actual Cost and ability to pay Side effects Importance of not being Perceptions, misperceptions, Likelihood and ability to Concomitant drug use pregnant comply Frequency of intercourse risk/benefit Health status and habits Age www.contraceptiononline.org Common Contraceptive Choices Oral contraceptives: combined, progestin-only Long-acting Injectable Implant IUD: copper T, progestin-only Barrier contraceptives Spermicides Natural family planning Emergency contraceptives Female/male sterilization www.contraceptiononline.org Current Trends in Contraception Developing new delivery systems Increasing access to a full range of options Emphasizing better compliance Widening use of emergency contraception www.contraceptiononline.org Oral Contraceptives Dosing: every day same time Rx refill Cost Not so private Side Effects Contraindications See handout Combined Progesterone only Plasma Drug Level (ng/mL) Levonorgestrel and Norethindrone Plasma Levels After Single Oral Dose 14 Norethindrone 1000 µg 12 Levonorgestrel 150 µg 10 8 6 4 2 0 0 6 12 18 24 30 Hours After Administration 36 42 Stanczyk FZ. In: Lobo RA, ed. Treatment of the Postmenopausal Woman: Basic and Clinical Aspects. Raven Press,1994. 48 www.contraceptiononline.org Drugs That Decrease the Effectiveness of OCs Anticonvulsants Barbituates (including phenobarbital and primidone) Anti-infectives Rifampin Griseofulvin Phenytoin Carbamazepine Toprimate Vigabatin American College of Obstetrics and Gynecology Practice Bulletin Number 18, July 2000 www.contraceptiononline.org Drugs That Do Not Decrease the Effectiveness of OCs Anti-infectives Tetracycline Doxycycline Ampicillin Metrondiazole Quinolone antibiotics American College of Obstetrics and Gynecology Practice Bulletin Number 18, July 2000 www.contraceptiononline.org Noncontraceptive Benefits of OCs Cycle-related: Cancer reduction: Irregular cycles Ovarian Dysmenorrhea Endometrial Menorrhagia Colorectal Anemia Functional ovarian cysts Adapted from Grimes DA et al, eds. Modern Contraception: Updates from The Contraception Report. Emron;1997:1-100 www.contraceptiononline.org Noncontraceptive Benefits of OCs Prevention of: Bone loss Fibrocystic/benign breast disease Pelvic inflammatory disease (PID) Ectopic pregnancy Treatment of: Acne Hirsutism Perimenopausal symptoms Adapted from Grimes DA et al, eds. Modern Contraception: Updates from The Contraception Report. Emron, 1997. www.contraceptiononline.org Community-Based Hospital-Based Case-Control Case-Control Cohort Studies Show OCs Reduce Risk of Ovarian Cancer Hildreth et al, Rosenberg et al, La Vecchia et al, Tzonou et al, Booth et al, Hartge et al, WHO, Wu et al, Prazzini et al, Newhouse et al, Casagrande et al, Cramer et al, Willet et al, Weiss, Risch et al, CASH, Harlow et al, Shu et al, Walnut Creek, Vessey et al, Beral et al, 1981 1982 1984 1984 1989 1989 1989 1988 1991 1977 1979 1982 1981 1981 1983 1987 1988 1989 1981 1987 1988 Summary of RR with ever-use of OC: 0.64 (95% CI, 0.57-0.73) 0.0 0.5 1.0 1.5 2.0 Relative Risk 2.5 3.0 3.5 Hankinson SE et al. Obstet Gynecol. 1991;80:708-714. www.contraceptiononline.org Ovarian Cancer and OCs Risk Reduction by Years of Use 10.0 CASH, 1987 Relative Risk (log scale) La Vecchia et al, 1986 Wu et al, 1988 Beral et al, 1988 1.0 0.1 1 2 3 4 5 6 7 8 Years of OC Use 9 10 11 12 Adapted from Grimes DA et al, eds. Modern Contraception: Updates from The Contraception Report. Emron, 1997. www.contraceptiononline.org OCs Protect Against Ovarian Cancer After Discontinuation 10.0 CASH, 1987 Relative Risk La Vecchia et al, 1986 Rosenberg et al, 1982 WHO, 1989 1.0 0.1 .5 1 5 1–4 5 5–9 10 Years Since Last OC Use Stanford JL. Contraception. 1991;43:543-556. www.contraceptiononline.org OCs Reduce Risk of Ovarian Cancer in High-Risk Women BRCA1 and BRCA2 mutations increase ovarian cancer risk 45% increased risk in carriers of BRCA 1 25% increased risk in carriers of BRCA 2 OCs reduce ovarian cancer risk in carriers of BRCA1 or BRCA2 20% reduction with short-term OC use (3 y) 60% reduction with long-term OC use (6 y) Narod SA et al. N Engl J Med. 1998;339:424-428. www.contraceptiononline.org Cohort Case Control Studies Show OCs Reduce Risk of Endometrial Cancer Horwitz et al, Weiss et al, Kaufman et al, Kelsey et al, Hulka et al, Henderson et al, La Vecchia et al, Pettersson et al, CASH, Koumantaki et al, WHO, Brinton et al, Jick et al, Ramcharan et al, Trapido, Beral et al, 1979 1980 1980 1982 1982 1983 1986 1986 1987 1989 1991 1983 1993 1981 1983 1988 0.0 0.5 1.0 1.5 2.0 Relative Risk Adapted from Grimes DA et al. Am J Obstet Gynecol. 1995;172:227-235. 2.5 3.0 3.5 www.contraceptiononline.org OCs Reduce Risk of Endometrial Cancer By Years of Use Yr 4 8 12 Relative Risk 10 RR 0.44 0.33 0.28 1 CASH, 1987 Levi et al, 1991 Stanford et al, 1993 Hulka et al, 1982 Kaufman et al, 1980 Weiss et al, 1980 0.1 0.01 0 2 4 6 8 10 12 Total Years of OC Use Adapted from Schlesselman JJ. Hum Reprod. 1997;12:1851-1863. www.contraceptiononline.org OCs Protect Against Endometrial Cancer After Discontinuation Yr 5 10 20 Relative Risk 10 1 La Vecchia, 1986 CASH, 1987 Levi et al, 1991 Stanford et al, 1993 Hulka et al, 1982 Kaufman et al, 1980 Weiss et al, 1980 0.1 0.01 RR 0.33 0.41 0.51 0 2 4 6 8 10 12 14 16 18 Years Since Last Use of Combined OCs 20 22 24 Adapted from Schlesselman JJ. Hum Reprod. 1997;12:1851-1863. www.contraceptiononline.org Ovarian and Endometrial Cancers and Low-Dose OCs Ovarian cancer If protective effect is due to prevention of “incessant ovulation,” low-dose OCs are likely protective Endometrial cancer Data on protective effect indicate no significant difference between 35 µg and >50 µg EE OCs Cancer and Steroid Hormone Study/CDC/NICHHD. JAMA. 1987;257:796-800; Rosenblatt KA et al. Eur J Cancer. 1992;28A:1872-1876. www.contraceptiononline.org Bone Mass and OC Use Studies Examining Association 9/13 studies show positive effects Up to 12% increase in BMD vs. control subjects Greatest protection with OC use of 10 y Primarily an estrogen effect; progestins may be important 4 studies show neutral effect No studies show decreased BMD with OC use Kuohung W et al. Contraception. 2000;61:77-82. www.contraceptiononline.org Higher Bone Density More Likely in OC Users OC users Non-OC users 100 80 60 40 20 0 4 1 2 3 (High) (Low) Bone Mineral Density Quartile Kleerekoper M et al. Arch Intern Med. 1991;151:1971-1976. www.contraceptiononline.org Higher Bone Density Association With Longer OC Use 0.6 Relative Risk of Low Bone Density 0.5 0.4 0.3 0.2 0.1 <2 2–4 4–6 6–8 8–10 >10 Years of OC Use Kleerekoper M et al. Arch Intern Med. 1991;151:1971-1976. www.contraceptiononline.org Do 20 µg EE OCs Increase Bone Mineral Density? 20 µg EE OCs: significant increases in vertebral bone density (oligomenorrheic, perimenopausal women) 0.625 mg conjugated equine estrogens (HRT) = ~ 5 µg EE 5 µg EE doses: demonstrate bone-sparing properties 20 µg EE OCs: protective benefits are maintained in perimenopausal women www.contraceptiononline.org Acne Androgen-stimulated disorder All OCs: Are antiandrogenic Reduce free testosterone Improve acne for most women www.contraceptiononline.org Acne Improvement with OCs % Improvement 90 82 80 70 70 60 50 48 40 30 20 76 80 Physician Global Assessment % Improvement Patient Assessment 90 80 70 63 60 50 40 30 20 10 10 0 0 Placebo 83 90 Norgestimate Levonorgestrel Allen HH et al. In: Update on Triphasic Oral Contraception. Excerpta Medica, 1982:82-99; Lemay A et al. J Clin Endocrinol Metab. 1990;71:8-14; Loudon NB et al. Update on Triphasic Oral Contraception. 1982:75-81; Redmond GP et al. Obstet Gynecol. 1997;89:615-622; Wishart JM. Australas J Dermatol. 1991;32:51-54. www.contraceptiononline.org Reductions in Inflammatory Lesion Counts at Cycle 6* EE 35 µg/NGM (Ortho Tri-Cyclen) vs. Placebo Mean Change 5 Study 1 Study 2 0 -5 -8 -10 -10 -12 P<.05 P<.05 -15 EE 35 ug/NGM Placebo *A negative change indicates improvement. Redmond et al. Obstet Gynecol. 1997;89:615-22; Lucky AW et al. J Am Acad Dermatol. 1997;37:746-754. www.contraceptiononline.org Reductions in Total Lesion Counts at Cycle 6* EE 35 µg/NGM (Ortho Tri-Cyclen) vs. Placebo 5 Study 1 Study 2 Mean Change 0 -5 -10 -14 -15 -19 -20 -25 -28 -29 -30 P<.05 P<.05 -35 EE 35 ug/NGM Placebo *Negative change indicates improvement. Redmond et al. Obstet Gynecol. 1997;89:615-22; Lucky AW et al. J Am Acad Dermatol. 1997;37:746-754. www.contraceptiononline.org Reductions in Inflammatory Lesion Counts at Cycle 6 EE 20 µg/LNG 100 µg (Alesse) vs. Placebo Mean % Change 5 Study 1 Study 2 0 -5 -7 -8 -10 -10 -15 -12 P<.05 P<.05 EE 20 ug/LNG 100 ug Placebo Lemay A et al. Gyneco Endocrinol. 2000;14:RT61; Leyden JJ et al. American Academy of Dermatology. March 2001;Washington, DC. www.contraceptiononline.org Reductions in Total Lesion Counts at Cycle 6 EE 20 µg/LNG 100 µg (Alesse) vs. Placebo 5 Study 1 Study 2 Mean % Change 0 -5 -10 -16 -15 -20 -25 -18 -25 -26 P<.05 P<.05 -30 -35 Alesse Placebo Lemay A et al. Gyneco Endocrinol. 2000;14:RT61; Leyden JJ et al. American Academy of Dermatology. March 2001;Washington, DC. www.contraceptiononline.org How OCs Improve Acne Ovarian and adrenal androgen secretion SHBG to bind androgens Free testosterone 5-reductase activity van der Vange N et al. Contraception. 1990;41:345-352; Cassidenti DL et al. Obstet Gynecol. 1991;78:103-107. www.contraceptiononline.org Primary Dysmenorrhea Incidence Wilson (n=88) Grade 0 (none) Mean age 15 Sundell (n=460) Age 19 Age 24 9% 28% 33% 1 (mild) 27% 35% 35% 2 (moderate) 41% 23% 22% 3 (severe) 23% 15% 10% Absenteeism* 26% 51% 34% * Missed classes or work. Wilson CA et al. J Adolesc Health Care. 1989;10:317-22; Sundell G et al. Br J Obstet Gynaecol. 1990;97:588-94. www.contraceptiononline.org OC Use in Adolescents Decreased Dysmenorrhea and Compliance Reduction of dysmenorrhea was the most statistically and clinically significant predictor of consistent OC use Adolescents with severe dysmenorrhea who experienced positive effects (decreased cramping or flow) were 8 times more likely to be consistent pill users (missed 3 pills per month) than others Robinson JC et al. Am J Obstet Gynecol. 1992;166:578-583. www.contraceptiononline.org Primary Dysmenorrhea 50% of women and 80% of adolescents report pain with menses OCs reduce menstrual fluid volume and prostaglandin levels OCs provide marked improvement of symptoms NSAIDs complement OC use Dawood MY. J Reprod Med. 1985;30:154-67;Wilson CA et al. J Adolesc Health Care. 1989;10:317-22. www.contraceptiononline.org How OCs Improve Primary Dysmenorrhea By ovulation inhibition, progesterone-stimulated endometrial prostaglandin production is reduced By reducing menstrual flow, which contains prostaglandins www.contraceptiononline.org OC Compliance A Real Concern with Adolescents Daily pill taking habit difficult Cost considerations Obtaining refills Misinformation about the pill www.contraceptiononline.org Reported Pill Use vs. Actual Pill Use 60 Diary % Women (Age 18 y) 50 Electronic device 40 30 20 10 0 0 1 Cycle 1 2 3 0 1 2 3 Cycle 2 Active Pills Missed 0 1 2 3 Cycle 3 Reproduced with permission from Potter L et al. Fam Plann Perspect. 1996;28:154-158. www.contraceptiononline.org Pill-Taking Behaviors by Age <=14 15-17 18-19 20-24 25-29 >=30 100 90 80 Percent' 70 60 50 40 30 20 10 0 Takes a pill qd Takes pill same time qd Takes pills in same order Uses backup if forgets Takes only own pills Oakley D et al. Fam Plann Perspect. 1991;23:150-154. www.contraceptiononline.org Continuation Rate (per 100 women enrolled) OC Continuation Rates All Ages OC switchers All OC users New OC starts 100 95 90 85 80 75 70 65 60 55 50 0 1 2 3 4 Study Month 5 6 Reproduced with permission from Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582. www.contraceptiononline.org Reasons for OC Discontinuation All Ages Method difficulty 14% Clinician recommended 9% Side effects 37% Other 17% No need 23% Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582. www.contraceptiononline.org What Happens When Women Discontinue OCs 42% discontinue without consulting their health- care provider 19% discontinue without selecting another contraceptive method 69% choose a less-effective contraceptive method Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582. www.contraceptiononline.org Patients at Risk for BTB First-time users Inconsistent users Users at risk for chlamydial cervicitis and endometritis Smokers www.contraceptiononline.org Breakthrough Bleeding in OC New Starts 35 µg EE OC vs. Two 20 µg EE OCs Bleeding Index 25 20 35 µg EE (Ortho Tri-Cyclen) 15 20 µg EE (Alesse and Mircette) 10 No significant differences 5 0 1 2 3 Cycle 4 Adapted from Rosenberg MJ et al. Contraception. 1999;60:321-329. 5 6 www.contraceptiononline.org Breakthrough Bleeding in OC Switchers 35 µg EE OC vs. Two 20 µg EE OCs Bleeding Index 25 20 35 µg EE (Ortho Tri-Cyclen) 15 10 20 µg EE (Alesse and Mircette) No significant differences 5 0 1 2 3 4 5 6 Adapted from Rosenberg MJ et al. Contraception. 1999;60:321-329. www.contraceptiononline.org OC Formulations and BTB Rates reported for different OCs are highly variable depending on study design and other factors Few randomized, prospective studies directly compare BTB between OCs Data do not support perception that 20 µg EE OCs generally have more BTB than 30–35 µg EE OCs Lynch CM. Contemporary OB/GYN. 2000 (suppl) www.contraceptiononline.org BTB May Signal Chlamydia Chlamydial infections are common in women of childbearing age — detected in 9.2% of female military recruits BTB in women previously well regulated on OCs is an added marker for chlamydial infection 29% of OC users with BTB tested positive for Chlamydia trachomatis vs. 11% without BTB but at high risk Gaydos CA et al. N Engl J Med. 1998;339:739-744; Krettek JE et al. Obstet Gynecol. 1993;81:728-731. www.contraceptiononline.org Smoking Affects Rates of BTB % With Spotting/Bleeding 60 * Smokers 50 Nonsmokers * P<.01 40 30 20 * * * * * 10 0 1 2 3 4 5 6 Cycle Reproduced with permission from Rosenberg M et al. Am J Obstet Gynecol. 1996;174:628-632. www.contraceptiononline.org Adolescents’ Anticipated vs. Reported Side Effects EE 20 µg/LNG 100 µg Formulation 60 Anticipated at baseline Reported at 6 months Percent 50 40 30 20 10 0 Weight gain Spotting Nausea Breast Mood Headaches tenderness changes Rosenthal SL et al. 12th World Congress of Pediatric & Adolescent Gynecology. June 1998;Helsinki, Finland. www.contraceptiononline.org Relative Risk of Estrogen-Related Side Effects 35 µg EE OC vs. Two 20 µg EE OCs Side Effect Relative Risk of 35 vs. 20 g EE OCs (Ortho Tri-Cyclen vs. Alesse and Mircette) Breast tenderness 1.5* Nausea 1.6* Bloating 1.4* *P<.05. Rosenberg MJ et al. Contraception. 1999;60:321-329. www.contraceptiononline.org Side Effects of EE 20 µg/LNG 100 µg (Alesse) vs. Placebo: No Significant Difference Alesse Placebo P-Value (n=349) % (n=355) % (Fisher’s Exact) Headache 31.5 30.1 .74 Nausea 14.0 11.3 .31 Weight gain 3.4 2.3 .37 Breast pain 4.6 3.1 .33 Adverse event Hordinsky M et al. 8th World Congress of the International Society of Gynecological Endocrinology. December 2000. Florence, Italy. www.contraceptiononline.org Weight Gain Is Not A Trivial Concern for OC Users Adolescents Major fear leading to discontinuation 85% of suburban teens cited weight gain as an important concern Adult women Common reason for self-initiated discontinuation Emans SJ et al. JAMA. 1987;257:3337-3381; Pratt WF et al. Fam Plann Perspect. 1987;19:257-266. www.contraceptiononline.org Women’s Perceptions About Weight Gain and OCs In a survey of 704 women aged 18-45 years: 20% report fear of weight gain is a reason they would not take or stop taking OCs 27% of those who had never taken OCs say, among other reasons, this was because of fear of weight gain 17% of current or previous OC users cite fear of gaining weight as a reason for discontinuation NANPWH Survey. 1999. www.contraceptiononline.org Controlled Studies Fail to Show Weight Gain Linked to OC Use Goldzieher et al, 1971 Placebocontrolled, double-blind crossover (N=380) Weight gain (5 lb) occurred in approximately 25% of women; no significant difference between placebo and OC groups (50 µg EE) Reubinoff et al, 1995 Prospective, randomized (N=49) No statistical difference in weight gain (0.5 kg) between OC users and nonusers (30 µg EE) Hordinsky et al, 2000 Placebocontrolled, double-blind crossover (N=721) No statistical difference in mean weight change after 6 mo between OC users and nonusers (EE 20 µg/LNG 100 µg, Alesse) Goldzieher JW et al. Fertil Steril. 1971;22:609-623; Reubinoff BE et al. Fertil Steril. 1995;63:516521; Hordinsky M et al. 8th World Congress of the International Society of Gynecological Endocrinology. December 2000. Florence, Italy. www.contraceptiononline.org The Press Underreports Studies of OC Benefits Media emphasizes negative rather than positive news about OCs 1986-1997: 9 studies on OC health effects published in N Engl J Med and JAMA All studies showed positive health effects 8 out of 9 studies ignored by major newspapers Lebow MA. Obstet Gynecol. 1999;93:453-456. Copyright © 1989 by the New York Times Co. Reprinted by permission. www.contraceptiononline.org Management of Side Effects Preventive/Anticipatory Guidance Acknowledge that side effects can be bothersome and uncomfortable Discuss breakthrough bleeding, nausea, weight gain at initial visit Set realistic expectations and counsel Most side effects improve over time Acne improvement is not immediate www.contraceptiononline.org How to Improve Successful Use of OCs Emphasize the many noncontraceptive benefits Cue pill-taking to daily activity Provide spare pack; advise to keep as emergency backup Provide written instructions Train office contact person to respond to calls www.contraceptiononline.org Improving Successful OC Use Anticipatory Guidance Individualize counseling to patient’s concerns and history Breakthrough bleeding Amenorrhea Side effects decrease over time Demonstrate how to use the actual pill pack Missed pills “Don’t stop taking the pills before calling me” www.contraceptiononline.org Adolescent Counseling Caution that OCs do not prevent STDs Discuss condom use: “How are you protecting yourself from AIDS?” Ask how she plans to discuss condom use with her partner Discuss emergency contraception www.contraceptiononline.org Depo Provera (3-month shot) Synthetic progesterone Private Requires clinic visit Q 3 months Effective in 24 hours Side Effects Contraindications Unexplained vaginal bleeding pregnancy Comparison of New Contraceptive Methods Implant Intrauterine system Ring Patch Yes Yes Yes Yes Yes 1 month Insertion & removal Insertion & removal Prescript ion Prescription Easily reversible Yes Yes Yes Yes Yes Dosing frequency 1 month 3-5 yrs 5 yrs Every 4 weeks Weekly Usercontrolled No No No Yes Yes Discreet Yes Sometimes Yes Yes Sometimes Efficacious Office Visits Monthly injectable www.contraceptiononline.org Contraceptive Implant: Implanon Single implant rod (4 cm in length and 2 mm in diameter) made of ethylene vinyl acetate Contains 68 mg of etonogestrel (3-keto-desogestrel), the active metabolite of desogestrel Effective for 3 years Inhibits ovulation during the entire treatment period www.contraceptiononline.org Implanon Efficacy, Safety and Tolerability No pregnancies in 1,200 women-years of exposure Good safety profile Irregular bleeding is most common adverse effect Requires clinician visit for initiation and discontinuation Single implant systems using newer progestins may solve some of the adverse effects and problems presented by earlier implants Zheng SR, et al. Contraception. 1999;60:1-8. Croxatto HB, et al. Hum Reprod. 1999;14:976-81. www.contraceptiononline.org Levonorgestrel Intrauterine System: Mirena Releases 20 g of levonorgestrel per 24 hrs Duration: 5 years Packaged with sterile inserter High efficacy Pearl Index of 0.1 (This is a schematic and is not anatomically proportional.) Lahteenmaki P, et al. Steroids. 2000;65:693-697. www.contraceptiononline.org Mirena Cycle Control, Safety, and Tolerability Requires clinician visit for initiation and discontinuation Early spotting Significant reduction in menstrual blood loss and high rate of amenorrhea High rates of continuation Hidalgo M, et al. Contraception. 2002;65:129-132. Lahteenmaki P, et al. Steroids. 2000;65:693-697. www.contraceptiononline.org Vaginal Ring: NuvaRing NuvaRing releases 15 g of ethinyl estradiol and 120 g of etonogestrel daily Worn for 3 out of 4 weeks Self insertion and removal Pregnancy rate 0.65 per 100 woman–years Roumen FJ, et al. Hum Reprod. 2001;16:469-475. www.contraceptiononline.org NuvaRing Efficacy Women Treatment cycles Pregnancies Pearl Index (95% CI) Intention to-Treat 1,145 Following Protocol 1,019 12,109 9,880 6 3 0.65 (0.08–1.16) 0.40 (0.24–1.41) Roumen FJ, et al. Hum Reprod. 2001;16:469-475. www.contraceptiononline.org NuvaRing Cycle Control and Tolerability Good cycle control Irregular bleeding was rare (2.6% - 6.4% of evaluable cycles) Withdrawal bleeding occurred (97.9% - 99.4% of evaluable cycles) Well tolerated and well accepted by users and their partners (only 5% of partners objected to use) Roumen FJ, et al. Hum Reprod. 2001;16:469-475. www.contraceptiononline.org NuvaRing Compared to OC: Irregular Bleeding * 40 NuvaRing Combined oral contraceptive 30 20 10 0 1 2 3 4 Cycle Number 5 6 *P<0.001 for COC vs NuvaRing Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186:389-395. www.contraceptiononline.org Contraceptive Patch: Ortho Evra Patch contains 6 mg norelgestromin and 0.75 mg ethinyl estradiol Delivers continuous systemic doses of hormones 150 µg norelgestromin (NGMN) 20 µg ethinyl estradiol (EE) Per day Direct comparisons to oral contraceptive delivery doses cannot be made www.contraceptiononline.org Ortho Evra Efficacy and Compliance High Efficacy Overall Pearl Index of 0.88 After 6 cycles, overall pregnancy possibility is half that of OC users May be less efficacious in women 198 lb (90 kg) NIH study in progress Compliance is superior with Ortho Evra compared to OC Ortho Evra compliance unaffected by age Lower compliance with OC in younger compared with older subjects Audet MC, et al. JAMA. 2001;285:2347-2354. Zieman M, et al. Fertility and Sterility 2002;77:S13-8. www.contraceptiononline.org Ortho Evra Compared to OC: Breakthrough Bleeding* % of patients 20 18 Patch 16 Oral contraceptive 14 12 10 8 6 3.7 4.2 4 2.9 4.5 2.7 1.3 2 0 3.1 3 1 3 6 Cycle 9 2.4 0 13 *The differences in the treatment groups were not statistically significant Audet MC, et al. JAMA. 2001;285:2347-2354. ©2001, American Medical Association. www.contraceptiononline.org Ortho Evra Compared to OC: Adverse Events Patch (n=812) OC (n=605) Overall Treatment limiting Overall Treatment limiting Breast discomfort 19% 1.0% 6% 0.2% Headache 22% 1.5% 22% 0.3% Application site reaction 20% 2.6% NA NA Nausea 20% 1.8% 18% 0.8% Abdominal pain 8% 0.2% 8% 0.3% Dysmenorrhea 13% 1.5% 10% 0.2% Audet MC, et al. JAMA. 2001;285:2347-2354. www.contraceptiononline.org Conclusions Clinicians should not assume they know what a woman’s contraceptive needs are After listening to a woman’s concerns, counseling should be non-directive and informative A menu of contraceptive options should be presented to all reproductive-aged women Consider using computer-based instruction or videos before the clinician consult to optimize education With good counseling, women will select a contraceptive method that best suits their needs www.contraceptiononline.org