3 Learning Objectives At the end of this presentation, the participant will be able to:Estimate underutilization of male condoms and suggest possible challenges to better use.Counsel couples on fertility awareness methods.Estimate the effectiveness of different methods of EC and their mechanisms of action.
4 “Ten months ago, I would have called this (the condom) an invention of the devil, but now I find that its inventor must have been a man of good will ...” Jacques Casanova, 1758
5 Condom Use and Remaining Need Worldwide, 6-9 billion condoms used each year24 billion condoms neededUnder-utilization not only from non-using couples but also from intermittent, inconsistent use by “condom users”Cecil M, et al. Contraception. 2010;82(6)
6 Male Condom Typical first year failure rate: 17.4%; range 2-20% Advantages:Male participation u Protects well against STDsInexpensive u Cervical dysplasia reducedReadily availableSpecial applications:Premature ejaculationAntisperm antibodyFemale allergy to spermKost K, et al. Contraception. 2008;77(1):10-21.
7 Male Condom Update Inconsistent use common1 Many new sizes needed2 New materials: polyisopreneNew incentives: ribbing, scents, vibrating ringsNew market strategies: to womenNew barriers: removed to locked casesNew biomarkers for failure3Addition of condoms to COCs could reduce STDs, unintended pregnancies and abortions41. Nelson AL, Am J Obstet Gynecol. 2006;164(6):2. Cecil M, et al. Contraception. 2010;82(6)3. Walsh T, et al. Contraception. 2012;86(1):55-61.4. Pazol K, et al. Public Health Rep. 2010;125(2):
8 STI Risk Reduction Use of condoms reduces risks of infection HIV 80% reduction in transmission (male infected to female non-infected)28.6% fewer births of HIV-positive babies than use of nevirapine in first 72 hours (potential)Gonorrhea and ChlamydiaSystematic review showed 80% reductionNelson A. Chapter 12, Contraception, 1st ed. Blackwell Publishing, 2011.
9 STI Risk Reduction Herpes Simplex Virus: Failed Vaccine Trial: frequent use reduced HSV-2 risk by 25%18 month study: use of condoms >25% of time reduced HSV-2 acquisition risk 92%HPV: Consistent use – incidence of infection reduced 70%Nelson A. Chapter 12, Contraception, 1st ed. Blackwell Publishing, 2011.
11 Consistent Condom Use Reported by Women Who Had Sexual Intercourse in the Prior 14 Days by Coital ActivityActs of coitus# women who had coitus% used condomsconsistently14867%23465%33566%42861%5 *2938%More than 5 *4340%All21756%* Cochran-Armitage test for trend over number of acts of coitus: p=0.001Nelson AL. Am J Obstet Gynecol. 2008;194(6):
12 Reasons Given for Not Using a Condom Percent ofresponsesNot perceived to be at risk44%He withdrew / pulled out / “took care”33%Used “rhythm” / Not at risk12%Ran out/did not have any condoms39%Dislike/Did not want to use condomsDislike condoms15%Did not want to use condoms19%Nelson AL. Am J Obstet Gynecol. 2008;194(6):
13 Reasons Given for Not Using a Condom (cont’d) Percent ofresponsesForgot condom9%Not necessary / Lazy7%Alternative methodOther3%Nelson AL. Am J Obstet Gynecol. 2008;194(6):
14 Other Worrisome Reasons Offered for Non-Use of Condoms “Too drunk”“He wanted me to use EC”“I do not know how to use it”“I did not think about it”“I see the same person”“In a rush”“I never check”“He told me to get on the pill”
15 The Top 5 Reasons For Not Using A Condom 1. “I didn’t know him well enough to ask him to use one.” 2. “After two months, I knew we were in love, so we stopped using them.” 3. “He would get mad at me if I asked him to.” 4. “He’s from Kansas, so I know he’s disease-free.” 5. “We don’t like them.”Real excuses collected by the PPLA clinic in Santa Monica, 1993.
16 The Top 12 Reasons For Not Using A Condom 6. “I know I should, but...” 7. “I’m on the pill.” 8. “Well, I did once!” 9. “He’s too big for the condom to fit.” 10. “I’m in a monogamous relationship.” 11. “We didn’t have any.” 12. “S/He looked clean.”Real excuses collected by the PPLA clinic in Santa Monica, 1993.
17 The Top 18 Reasons For Not Using A Condom 13. “She’s a virgin.” 14. “You can’t get AIDS from a woman.” 15. “He worked for TRW. He must be clean.” 16. “Well, I already have herpes and warts.” 17. “I’m not in a high-risk group.” 18. “I can’t feel anything when we use them.”Real excuses collected by the PPLA clinic in Santa Monica, 1993.
18 Male Condoms: Sizes Snug fitting Larger size—more headroom Beyond7, Studded Beyond 7, Exotica Snugger Fit, LifeStyles Snugger Fit, Trojan Ultra FitLarger size—more headroomTrojan Ultra Pleasure, Trojan Very Sensitive, Bareback, Trojan Her Pleasure, Midnight Desire, Pleasure Plus, LifeStyles Xtra Pleasure, Inspiral, Durex Enhanced Pleasure, LifeStyles Natural FeelingLarger size—roomy from top to bottomMaxx, Trojan Large, Magnum XL, Magnum, Durex Maximum, LifeStyles Large, Avanti, Crown, Trojan Supra
19 Need for New Condom Sizes French clinical condom trial, 2003:39% said latex condom too small or too largeUS Survey 2009: 1661 men17% condoms too long12% condom too short32% too tight10% too looseAustralia: 3/5 reasons: Too tight, too short, too looseCecil M, et al. Contraception. 2010;82(6)
20 Male Condoms: Other Characteristics Sensitivity, texture, extra strength, desensitizing, pleasure producing, flavor/scent, color, lubricationDesensitizing condoms with “climax control lubricant featuring benzocaine that helps prolong sexual pleasure and aids in prevention of premature ejaculation” (Durex Performax, Trojan Extended Pleasure)Spermicidally lubricated condoms
22 Female Barrier Update Contraceptive sponge variably available Female condom FC2 (nitrile)Use of female vs. male condomLess ejaculation, less active coitus, shorter coital duration1New female condoms under developmentSILCs diaphragm2 day methodStandard days method with beads1. Haddad L, et al. Contraception. 2012;86(4)
24 Contraceptive SpongeApproved by FDA in 1983, withdrawn in 1994, and reapproved in 2005Disposable polyurethane foam disk containing 1 gram N-9Single use device moistened and placed high in vault to cover cervixMechanisms of action: spermicide (24 hours) plus device absorbs semen and blocks cervix
25 Female Condom – Take 2: FC2 Made of nitrile (synthetic latex) FDA approvedReduced cost compared to FC1Still more expensive than male condomComparable to FC1 in breakage, invagination, slippage and misdirection, efficacy, ease of insertion, comfort and overall experienceInternationally, other female condoms:The Reddy CondomNational Sensation Panty CondomSchwartz J. The Female Patient. 2009;34:26-9.
26 Fertility Awareness Methods Ovulation detection methods often combined to increase effectiveness:CalendarBasal body temperatureCervical mucusSympto-thermalCervical palpationPost ovulationTypical failure rate: 25.3%Kost K, et al. Contraception. 2008;77(1):10-21.
27 Calendar or Rhythm Method Collect information about menses from at least 6 months of experienceAssumptions:Sperm vulnerable for 3 daysOvum vulnerable for 24 hoursLuteal phase lasts 14 +/- 2 daysFormulas used to calculate at risk days:Cycle day [length of shortest cycle – 18] to Cycle day [length or longest cycle – 11]On average 13 days of abstinence/monthProvides 67.8% of coverage of peak risk days
28 Calculation of Fertile Period Shortest Cycle (Days)First Fertile (Unsafe) DayLongest Cycle (Days)Last Fertile (Unsafe) Day2131023512257142791629111832351724Day 1 = First day of menstrual bleeding.Hatcher RA, et al. Contraceptive Tech. 18th Ed. New York: Ardent Media, 2004
29 Newer Methods to Identify At-Risk Days Standard Days Methods with CycleBeads2-day methodPersona (not available in US)Computer programOV-Watch®Urinary ovulation kitsNot recommended–too late!
30 Cycle BeadsColor coded string of beads helps women identify days of cycle pregnancy is likely and unlikely
31 2-Day Method Simplified Billings technique Woman checks introital secretions daily and asks herself 2 questions:Was I dry yesterday?Am I dry today?Only if the answers to both questions are yes is intercourse allowedFailure rates comparable to other FAMs
32 Persona Hand-held ovulation detection monitor Not available in US Enter menses each monthCheck each day: indicator light provides directionRed/Green – obvious interpretationYellow – dip test strip in urine to detect LH and E3G levelsLight turns green or redOver time, computer able to reduce number of uncertain (yellow light) days
33 Other Monitors Lady Free Biotester OV-Watch® Fertility Predictor Hand held microscope to check saliva for ferningOV-Watch® Fertility PredictorWrist computerAnalyzes chloride ions in perspiration on wrist during sleepSurge in chloride ions occurs 6 days prior to ovulationMessage on watch: “Fertile Day 01 – 06”
34 Lactational Amenorrhea Support women inclined to nurse their newbornsSexual activity, contraception will not affect nursingBenefit to motherBonding with newbornProtection against ovarian, premenopausal breast cancerLower cost than formulaBenefit to newbornPerfectly balanced nutritionBonding with motherReduction in newborn allergies and infections
35 Contraceptive Sexual Practices Withdrawal.Rectal intercourse.Oral intercourse.Other.
36 LNG-only EC Single-dose Versus 2-dose Regimens 2 doses mg1 dose 1.5 mgPregnancies7/5604/600Effectiveness86.8%92.9%Headaches14.5%21.3%Breast tenderness8.8%12.9%No differences seen in nausea, vomiting, dizziness, lower abdominal pain, or heavy menses.Arowojolu AO, et al. Contraception. 2002;66:
37 LNG EC Mechanisms of Action Cebus monkey: LNG EC inhibited or delayed ovulation. Once fertilization had taken place, EC did not prevent establishment of pregnancy 1Human: LNG administered during luteul phase did not cause significant endometrial changes 2Human: LNG EC blocks or delays ovulation, due either to prevention or delay of LH surge, rather than inhibiting implantation 31. Ortiz ME, et al. Hum Reprod. 2004;19:2. von Hertzen H, et al. Fam Plann Perspect. 1996;28:52-7,88.3. Gemzell-Danielsson K, et al. Hum Reprod Update. 2004;10:341-8.
38 LNG EC Mechanisms of Action 99 womenOvulation (day 0) calculated from LH, E2 and P4 levels obtained just prior to EC ingestionCycle day of IC derived from patient historyNo pregnancies occurred when IC occurred day -5 to day -2 and EC taken before or on day 04-5 pregnancies expected, 0 occurredAll pregnancies occurred when IC was day -1 to day 0 and EC was day +23-4 pregnancies expected, 3 occurredNovikova N, et al. Contraception 2007;75:112-8.
39 Cycle Phase: Endocrinological vs Patient Estimate Women in Cycle PhaseFollicularPeriovulatoryLutealNumber413020Percent believing they are in phase39%13%7%17%23%18%53%68%Unknown5%11%Novikova N, et al. Contraception. 2007;75:112-8.
40 Meloxicam 15mg Boosts LNG-EC Efficacy Cox-2 inhibitor added to LNG-ECCyclo-oxygenase (Cox-2) catalyses final step of PG synthesis needed for follicle rupture% Failed Follicle RuptureFollicle Size15-17 mm≥ 18 mmOverallLNG-EC + Placebo50%70%66%LNG-EC + Meloxicam16%39%88%Massai MR, et al. Hum Reprod. 2007;22(2):434-9.
41 Challenges of OTC EC Patient has to pay out of pocket for LNG EC Many pharmacies do not carry2008 telephone survey of all 1460 pharmacies in LA County as sham adult patient69% had EC available19% referred “elsewhere”12% said nothing could be done or hung upNelson AL, et al. Contraception. 2009;79(3):
42 Challenges of OTC EC Misinformation provided callers: “Abortion Pill” “Used to be available, isn’t anymore”“Have to be 21 to buy”“Only women can buy”“You could be pregnant if you had sex last night”“Have to take within 12 hours”“Have to take within 24 hours”“Have to wait 48 hours to take”Nelson AL, et al. Contraception. 2009;79(3):
43 Challenges of OTC EC Unprofessional comments made: “You could use it, or you could have a beautiful little baby”“Why aren’t you on the pill?”“Are you married or single?”“Have you had sex before?”“How long have you known him?“Did he ejaculate inside you?”“Did he come inside you?”Nelson AL, Jaime CM Contraception. 2009;79(3):
44 Ulipristal Acetate Selective progesterone receptor modulator 30 mg micronized versionWorks as well as LNG in first 72 hoursMay be given up to 120 hoursPrevents ovulation and fertilizationWorks even after the luteinizing hormone surge has begunFine P, et al. Obstet Gynecol. 2010;115(2 Pt 1):
45 Ulipristal Acetate for Emergency Contraception 1553 treatments of women hours after unprotected intercourse30 mg Ulipristal acetate orallyPregnancy rateOverall 2.1%%%%Cycle length increased a mean of 2.8 daysDuration of bleeding did not changeFine P, et al. Obstet Gynecol. 2010;115(2 Pt 1):
46 Ulipristal Acetate Ovulation Suppression up to 120 Hours 34 women on ulipristal vs. 34 placebo with follicle ≥18mmAll women ovulatedUlipristal given # SuppressedBefore LH surge start /8After LH rise before peak /14After LH peak /16Brache V. et al Human Reprod :
47 Ulipristal Acetate Adverse Events % of ITTHeadache9.3Nausea9.2Abdominal pain6.8Dysmenorrhea4.1Dizziness3.5Fatigue3.4Fine P, et al. Obstet Gynecol. 2010;115(2 Pt 1):
48 Overweight and Obese Women Have Higher EC Failure Rates with LNG-EC Pregnancy RatesBMILNG-ECUPA-EC< 25 kg/m21.3%1.1%kg/m22.5%≥ 30 kg/m25.8%2.6%Further coitus7.3%5.6%Glaiser A, et al. Contraception. 2011;84(4):363-7.
49 Remaining Issues for UPA: Role in Quick Start Protocols Concern: Ulipristal acetate is a selective progesterone receptor modulator (SPRM).Binds to progesterone receptor to block progesterone actionIf provide pharmacologic doses of progestin in contraceptive near time of administration of SPRM, will that diminish effect of SPRM?
50 Copper IUD for EC 8400 postcoital copper IUD placements1 Pregnancy rate 0.1% to 0.7%Prospective trial: 1963 CuT380A placements within 120 hours 2No pregnancies; No PID94.3% parous women continued at 12 months88.2% nulliparous women continued for 1 yearChinese trial: 1933 women within 120 hours 3Pregnancy rate: 0.13%1. Trussell J, et al. Fertil Control Rev. 1995;4: 8-11.2. Wu S, et al. BJOG. 2010;117:3. Bilian X. Contraception. 2007;75:S31-4.
51 Emergency contraception Use within 3 days of opening If you’ve been swept off your feet You’ve got 3 days to get them back on the groundEmergency contraception Use within 3 days of opening