Barriers, Behavior Methods and Emergency Contraceptives
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Transcript of Barriers, Behavior Methods and Emergency Contraceptives
Barriers, Behavior Methods and Emergency Contraceptives
Contemporary Forums
Anita L. Nelson, MDHarbor-UCLA Medical Center
Anita L. Nelson, MD 2Barrier Methods 2013 Contemporary Forums
Conflict of Interest DisclosureAnita 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
Anita L. Nelson, MD 3Barrier Methods 2013 Contemporary Forums
Learning ObjectivesAt the end of this presentation, theparticipant 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.
Anita L. Nelson, MD 4Barrier Methods 2013 Contemporary Forums
“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
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Condom Use and Remaining Need
Worldwide, 6-9 billion condoms used each year
24 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) 489-90.
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Male CondomTypical first year failure rate: 17.4%; range 2-
20%Advantages:
Male participation u Protects well against STDs
Inexpensive u Cervical dysplasia reduced
Readily availableSpecial applications:
Premature ejaculation Antisperm antibody Female allergy to spermKost K, et al. Contraception. 2008;77(1):10-21.
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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 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.
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STI Risk ReductionUse of condoms reduces risks of infectionHIV
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.
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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.
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The Male Condom
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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):1710-6.
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Reasons Given for Not Using a Condom
ReasonPercent 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 33% Dislike condoms 15% Did not want to use condoms 19%Nelson AL. Am J Obstet Gynecol. 2008;194(6):1710-6.
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Reasons Given for Not Using a Condom (cont’d)
ReasonPercent of responses
Forgot condom 9%
Not necessary / Lazy 7%
Alternative method 7%
Other 3%
Nelson AL. Am J Obstet Gynecol. 2008;194(6):1710-6.
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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”
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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.
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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.
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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.
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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
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Need for New Condom SizesFrench clinical condom trial, 2003:
39% said latex condom too small or too largeUS 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.
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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
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Recently Introduced Condoms
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Female Barrier UpdateContraceptive sponge variably availableFemale condom FC2 (nitrile)Use of female vs. male condom
Less ejaculation, less active coitus, shorter coital duration1
New female condoms under developmentSILCs diaphragm2 day methodStandard days method with beads
1. Haddad L, et al. Contraception. 2012;86(4) 391-6.
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FemCap
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Contraceptive SpongeApproved by FDA in 1983, withdrawn in
1994, and reapproved in 2005 Disposable polyurethane foam disk
containing 1 gram N-9Single use device
moistened and placed high in vault to cover cervix
Mechanisms of action: spermicide (24 hours) plus device absorbs semen and blocks cervix
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Female Condom – Take 2: FC2Made 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 CondomNational Sensation Panty Condom
Schwartz J. The Female Patient. 2009;34:26-9.
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Fertility Awareness MethodsOvulation 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.
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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
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Calculation of Fertile PeriodShortest Cycle (Days)
First Fertile (Unsafe)
Day
Longest Cycle (Days)
Last Fertile (Unsafe)
Day21 3 21 1023 5 23 1225 7 25 1427 9 27 1629 11 29 1832 14 32 2135 17 35 24
Day 1 = First day of menstrual bleeding. Hatcher RA, et al. Contraceptive Tech. 18th Ed. New York: Ardent Media, 2004
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Newer Methods to Identify At-Risk Days
Standard Days Methods with CycleBeads2-day methodPersona (not available in US)Computer programOV-Watch®
Urinary ovulation kits Not recommended–too late!
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Cycle BeadsColor coded string of beads helps women
identify days of cycle pregnancy is likely and unlikely
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2-Day Method
Simplified Billings techniqueWoman 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
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PersonaHand-held ovulation
detection monitorNot available in USEnter menses each monthCheck each day: indicator
light provides direction Red/Green – obvious interpretation Yellow – dip test strip in urine to detect LH
and E3G levelsLight turns green or red
Over time, computer able to reduce number of uncertain (yellow light) days
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Other MonitorsLady 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”
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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
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Contraceptive Sexual Practices
Withdrawal.Rectal intercourse.Oral intercourse.Other.
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LNG-only ECSingle-dose Versus 2-dose Regimens
2 doses
0.75 mg
1 dose
1.5 mgPregnancies 7/560 4/600Effectiveness 86.8% 92.9%Headaches 14.5% 21.3%Breast tenderness
8.8% 12.9%
Arowojolu AO, et al. Contraception. 2002;66:269-73.
● No differences seen in nausea, vomiting, dizziness, lower abdominal pain, or heavy menses.
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LNG EC Mechanisms of ActionCebus 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. Fam Plann Perspect. 1996;28:52-7,88.3. Gemzell-Danielsson K, et al. Hum Reprod Update. 2004;10:341-8.
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LNG EC Mechanisms of Action99 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 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.
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Cycle Phase: Endocrinological vs Patient Estimate
Women in Cycle PhaseFollicular Periovulatory Luteal
Number 41 30 20Percent believing they are in phase
Follicular 39% 13% 7%Periovulatory 17% 23% 18%
Luteal 39% 53% 68%Unknown 5% 11% 17%
Novikova N, et al. Contraception. 2007;75:112-8.
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Meloxicam 15mg Boosts LNG-EC Efficacy
% Failed Follicle Rupture Follicle Size
15-17 mm ≥ 18 mm OverallLNG-EC + Placebo 50% 70% 66%LNG-EC + Meloxicam 16% 39% 88%
Massai MR, et al. Hum Reprod. 2007;22(2):434-9.
Cox-2 inhibitor added to LNG-ECCyclo-oxygenase (Cox-2) catalyses final step
of PG synthesis needed for follicle rupture
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Challenges of OTC EC
Patient has to pay out of pocket for LNG ECMany pharmacies do not carry
2008 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 up
Nelson AL, et al. Contraception. 2009;79(3):206-10.
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Challenges of OTC ECMisinformation 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.
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Challenges of OTC ECUnprofessional 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.
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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.
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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.
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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 al Human Reprod. 2010 25:2256-63.
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Ulipristal Acetate Adverse Events
Adverse Eventsn= 1,553
% of ITT
Headache 9.3Nausea 9.2Abdominal pain 6.8Dysmenorrhea 4.1Dizziness 3.5Fatigue 3.4
Fine P, et al. Obstet Gynecol. 2010;115(2 Pt 1):257-63.
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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%
25 - 29.9 kg/m2 2.5% 1.1%
≥ 30 kg/m2 5.8% 2.6%
Further coitus 7.3% 5.6%
Glaiser A, et al. Contraception. 2011;84(4):363-7.
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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?
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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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If you’ve been swept off your feetYou’ve got 3 days to get them back on the ground
Emergency contraceptionUse within 3 days of opening