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


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.


“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


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.


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.


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.


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.


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.


The Male Condom


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.


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.


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.


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”


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.



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.”




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.”



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


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.


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


Recently Introduced Condoms


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.


FemCap


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


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.


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.


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


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


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!


Cycle BeadsColor coded string of beads helps women

identify days of cycle pregnancy is likely and unlikely


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


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


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”


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


Contraceptive Sexual Practices

Withdrawal.Rectal intercourse.Oral intercourse.Other.


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.


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.


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.


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.


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


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.


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.


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.


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.


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



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.


Ulipristal Acetate Adverse Events

Adverse Eventsn= 1,553

% of ITT

Headache 9.3Nausea 9.2Abdominal pain 6.8Dysmenorrhea 4.1Dizziness 3.5Fatigue 3.4



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.


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?


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.


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

Documents

Barriers, Behavior Methods and Emergency Contraceptives