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Barriers, Behavior Methods and Emergency Contraceptives

Barriers, Behavior Methods and Emergency Contraceptives. Anita L. Nelson, MD Harbor-UCLA Medical Center. Contemporary Forums . Conflict of Interest Disclosure Anita L. Nelson, MD. Learning Objectives. At the end of this presentation, the participant will be able to:

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Barriers, Behavior Methods and Emergency Contraceptives

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  1. Barriers, Behavior Methods and Emergency Contraceptives Anita L. Nelson, MD Harbor-UCLA Medical Center Contemporary Forums

  2. Conflict of Interest DisclosureAnita L. Nelson, MD

  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) aninvention 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 year • 24 billion condoms needed • Under-utilization not only from non-using couples but also from intermittent, inconsistent use by “condom users” Cecil M, et al. Contraception.2010;82(6) 489-90.

  6. Male Condom • Typical first year failure rate: 17.4%; range 2-20% • Advantages: • Male participation u Protects well against STDs • Inexpensive u Cervical dysplasia reduced • Readily available • Special applications: • Premature ejaculation • Antisperm antibody • Female allergy to sperm Kost K, et al. Contraception. 2008;77(1):10-21.

  7. Male Condom Update • Inconsistent use common1 • Many new sizes needed2 • New materials: polyisoprene • New incentives: ribbing, scents, vibrating rings • New market strategies: to women • New barriers: removed to locked cases • New biomarkers for failure3 • Addition of condoms to COCs could reduce STDs, unintended pregnancies and abortions4 1. Nelson AL, Am J Obstet Gynecol. 2006;164(6):1710-5. 2. Cecil M, et al. Contraception.2010;82(6) 489-90. 3. Walsh T, et al. Contraception. 2012;86(1):55-61. 4. Pazol K, et al. Public Health Rep. 2010;125(2):208-17.

  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 Chlamydia • Systematic review showed 80% reduction Nelson 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.

  10. The Male Condom

  11. Consistent Condom Use Reported by Women Who Had Sexual Intercourse in the Prior 14 Days by Coital Activity * Cochran-Armitage test for trend over number of acts of coitus: p=0.001 Nelson AL. Am J Obstet Gynecol. 2008;194(6):1710-6.

  12. Reasons Given for Not Using a Condom Nelson AL. Am J Obstet Gynecol. 2008;194(6):1710-6.

  13. Reasons Given for Not Using a Condom (cont’d) Nelson AL. Am J Obstet Gynecol. 2008;194(6):1710-6.

  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 • Beyond7, Studded Beyond 7, Exotica Snugger Fit, LifeStyles Snugger Fit, Trojan Ultra Fit • Larger size—more headroom • Trojan Ultra Pleasure, Trojan Very Sensitive, Bareback, Trojan Her Pleasure, Midnight Desire, Pleasure Plus, LifeStyles Xtra Pleasure, Inspiral, Durex Enhanced Pleasure, LifeStyles Natural Feeling • Larger size—roomy from top to bottom • Maxx, 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 large • US Survey 2009: 1661 men • 17% condoms too long • 12% condom too short • 32% too tight • 10% too loose • Australia: 3/5 reasons: Too tight, too short, too loose Cecil M, et al. Contraception.2010;82(6) 489-90.

  20. Male Condoms: Other Characteristics • Sensitivity, texture, extra strength, desensitizing, pleasure producing, flavor/scent, color, lubrication • Desensitizing 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

  21. Recently Introduced Condoms

  22. Female Barrier Update • Contraceptive sponge variably available • Female condom FC2 (nitrile) • Use of female vs. male condom • Less ejaculation, less active coitus, shorter coital duration1 • New female condoms under development • SILCs diaphragm • 2 day method • Standard days method with beads 1. Haddad L, et al. Contraception.2012;86(4) 391-6.

  23. FemCap

  24. Contraceptive Sponge • Approved by FDA in 1983, withdrawn in 1994, and reapproved in 2005 • Disposable polyurethane foam disk containing 1 gram N-9 • Single use device moistened and placed high in vault to cover cervix • Mechanisms of action: spermicide (24 hours) plus device absorbs semen and blocks cervix

  25. Female Condom – Take 2: FC2 • Made of nitrile (synthetic latex) FDA approved • Reduced cost compared to FC1 • Still more expensive than male condom • Comparable to FC1 in breakage, invagination, slippage and misdirection, efficacy, ease of insertion, comfort and overall experience • Internationally, other female condoms: • The Reddy Condom • National Sensation Panty Condom Schwartz J. The Female Patient. 2009;34:26-9.

  26. Fertility Awareness Methods • Ovulation detection methods often combined to increase effectiveness: • Calendar • Basal body temperature • Cervical mucus • Sympto-thermal • Cervical palpation • Post ovulation • Typical 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 experience • Assumptions: • Sperm vulnerable for 3 days • Ovum vulnerable for 24 hours • Luteal phase lasts 14 +/- 2 days • Formulas used to calculate at risk days: • Cycle day [length of shortest cycle – 18] toCycle day [length or longest cycle – 11] • On average 13 days of abstinence/month • Provides 67.8% of coverage of peak risk days

  28. Calculation of Fertile Period Day 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 CycleBeads • 2-day method • Persona (not available in US) • Computer program • OV-Watch® • Urinary ovulation kits • Not recommended–too late!

  30. Color coded string of beads helps women identify days of cycle pregnancy is likely and unlikely Cycle Beads

  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 allowed • Failure rates comparable to other FAMs

  32. Persona • Hand-held ovulation detection monitor • Not available in US • Enter menses each month • Check each day: indicator light provides direction • Red/Green – obvious interpretation • Yellow – dip test strip in urine to detect LH and E3G levels • Light turns green or red • Over time, computer able to reduce number of uncertain (yellow light) days

  33. Other Monitors • Lady Free Biotester • Hand held microscope to check saliva for ferning • OV-Watch® Fertility Predictor • Wrist computer • Analyzes chloride ions in perspiration on wrist during sleep • Surge in chloride ions occurs 6 days prior to ovulation • Message on watch: “Fertile Day 01 – 06”

  34. Lactational Amenorrhea • Support women inclined to nurse their newborns • Sexual activity, contraception will not affect nursing • Benefit to mother • Bonding with newborn • Protection against ovarian, premenopausal breast cancer • Lower cost than formula • Benefit to newborn • Perfectly balanced nutrition • Bonding with mother • Reduction in newborn allergies and infections

  35. Contraceptive Sexual Practices • Withdrawal. • Rectal intercourse. • Oral intercourse. • Other.

  36. LNG-only ECSingle-dose Versus 2-dose Regimens • No differences seen in nausea, vomiting, dizziness, lower abdominal pain, or heavy menses. Arowojolu AO, et al. Contraception. 2002;66:269-73.

  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 1 • Human: LNG administered during luteul phase did not cause significant endometrial changes 2 • Human: LNG EC blocks or delays ovulation, due either to prevention or delay of LH surge, rather than inhibiting implantation 3 1. Ortiz ME, et al. Hum Reprod. 2004;19:1352-6. 2. von Hertzen H, et al. FamPlannPerspect. 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 women • Ovulation (day 0) calculated from LH, E2 and P4 levels obtained just prior to EC ingestion • Cycle day of IC derived from patient history • No pregnancies occurred when IC occurred day -5 to day -2 and EC taken before or on day 0 • 4-5 pregnancies expected, 0 occurred • All pregnancies occurred when IC was day -1 to day 0 and EC was day +2 • 3-4 pregnancies expected, 3 occurred Novikova N, et al. Contraception2007;75:112-8.

  39. Cycle Phase: Endocrinological vs Patient Estimate Novikova N, et al. Contraception.2007;75:112-8.

  40. Meloxicam 15mg Boosts LNG-EC Efficacy • Cox-2 inhibitor added to LNG-EC • Cyclo-oxygenase (Cox-2) catalyses final step of PG synthesis needed for follicle rupture MassaiMR,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 carry • 2008 telephone survey of all 1460 pharmacies in LA County as sham adult patient • 69% had EC available • 19% referred “elsewhere” • 12% said nothing could be done or hung up Nelson AL, et al. Contraception.2009;79(3):206-10.

  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):206-10.

  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):206-10.

  44. Ulipristal Acetate • Selective progesterone receptor modulator • 30 mg micronized version • Works as well as LNG in first 72 hours • May be given up to 120 hours • Prevents ovulation and fertilization • Works even after the luteinizing hormone surge has begun Fine P, et al. Obstet Gynecol.2010;115(2 Pt 1):257-63.

  45. Ulipristal Acetate for Emergency Contraception • 1553 treatments of women 48-120 hours after unprotected intercourse • 30 mg Ulipristal acetate orally • Pregnancy rate • Overall 2.1% • 48-72 2.3% • 72-96 2.1% • 96-120 1.3% • Cycle length increased a mean of 2.8 days • Duration of bleeding did not change Fine P, et al. Obstet Gynecol.2010;115(2 Pt 1):257-63.

  46. Ulipristal Acetate Ovulation Suppression up to 120 Hours • 34 women on ulipristal vs. 34 placebo with follicle ≥18mm • All women ovulated • Ulipristal given # Suppressed • Before LH surge start 8/8 • After LH rise before peak 11/14 • After LH peak 1/16 Brache V. et alHuman Reprod.2010 25:2256-63.

  47. Ulipristal Acetate Adverse Events Fine P, et al. Obstet Gynecol.2010;115(2 Pt 1):257-63.

  48. Overweight and Obese Women Have Higher EC Failure Rates with LNG-EC 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 action • If 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 2 • No pregnancies; No PID • 94.3% parous women continued at 12 months • 88.2% nulliparous women continued for 1 year • Chinese trial: 1933 women within 120 hours 3 • Pregnancy rate: 0.13% 1. Trussell J, et al. Fertil Control Rev. 1995;4: 8-11. 2. Wu S, et al. BJOG.2010;117:1205-10. 3. Bilian X. Contraception.2007;75:S31-4.

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