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Barriers, Behavior Methods and Emergency Contraceptives

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Presentation on theme: "Barriers, Behavior Methods and Emergency Contraceptives"— Presentation transcript:

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

2 Conflict of Interest Disclosure Anita L. Nelson, MD
Grants/ Research Bayer, Merck, Pfizer, Teva Honoraria/ Speakers Bureau Bayer, Merck, Pfizer, Teva, Watson Consultant/ Advisory Board Agile, Bayer, Merck, Teva, Watson

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 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)

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): 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 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 Acts of coitus # women who had coitus % used condoms consistently 1 48 67% 2 34 65% 3 35 66% 4 28 61% 5 * 29 38% More than 5 * 43 40% All 217 56% * Cochran-Armitage test for trend over number of acts of coitus: p=0.001 Nelson AL. Am J Obstet Gynecol. 2008;194(6):

12 Reasons Given for Not Using a Condom
Percent of responses Not perceived to be at risk 44% He withdrew / pulled out / “took care” 33% Used “rhythm” / Not at risk 12% Ran out/did not have any condoms 39% Dislike/Did not want to use condoms Dislike condoms 15% Did not want to use condoms 19% Nelson AL. Am J Obstet Gynecol. 2008;194(6):

13 Reasons Given for Not Using a Condom (cont’d)
Percent of responses Forgot condom 9% Not necessary / Lazy 7% Alternative method Other 3% 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 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)

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)

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] to Cycle 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
Shortest Cycle (Days) First Fertile (Unsafe) Day Longest Cycle (Days) Last Fertile (Unsafe) Day 21 3 10 23 5 12 25 7 14 27 9 16 29 11 18 32 35 17 24 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 Cycle Beads Color 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 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 OV-Watch® Fertility Predictor
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 EC Single-dose Versus 2-dose Regimens
2 doses mg 1 dose 1.5 mg Pregnancies 7/560 4/600 Effectiveness 86.8% 92.9% Headaches 14.5% 21.3% Breast tenderness 8.8% 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 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: 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 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. Contraception 2007;75:112-8.

39 Cycle Phase: Endocrinological vs Patient Estimate
Women in Cycle Phase Follicular Periovulatory Luteal Number 41 30 20 Percent believing they are in phase 39% 13% 7% 17% 23% 18% 53% 68% Unknown 5% 11% 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 % Failed Follicle Rupture Follicle Size 15-17 mm ≥ 18 mm Overall LNG-EC + Placebo 50% 70% 66% LNG-EC + Meloxicam 16% 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 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):

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 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):

45 Ulipristal Acetate for Emergency Contraception
1553 treatments of women hours after unprotected intercourse 30 mg Ulipristal acetate orally Pregnancy rate Overall 2.1% % % % 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):

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 After LH rise before peak /14 After LH peak /16 Brache V. et al Human Reprod :

47 Ulipristal Acetate Adverse Events
% of ITT Headache 9.3 Nausea 9.2 Abdominal pain 6.8 Dysmenorrhea 4.1 Dizziness 3.5 Fatigue 3.4 Fine P, et al. Obstet Gynecol. 2010;115(2 Pt 1):

48 Overweight and Obese Women Have Higher EC Failure Rates with LNG-EC
Pregnancy Rates BMI LNG-EC UPA-EC < 25 kg/m2 1.3% 1.1% kg/m2 2.5% ≥ 30 kg/m2 5.8% 2.6% Further coitus 7.3% 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 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: 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 ground Emergency contraception Use within 3 days of opening


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