Transcript Document

Contraceptive Update
Anita L. Nelson, MD
Harbor-UCLA Medical Center
35th Annual CAPA Conference
Palm Spring, CA
September 22 – September 25, 2011
Conflict of Interest Disclosure
Anita L. Nelson, MD
Grants/
Research
Honoraria/
Speakers Bureau
Consultant/
Advisory Board
Anita L. Nelson, MD - 4/5/2016 8:38 PM
Bayer,
Merck, Pfizer, Teva
Bayer,
Merck, Pfizer, Teva
Bayer, Merck, Teva
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Learning Objectives
At the end of this presentation, the
participant will be able to:
• Counsel patients on the full array of
contraceptive choices, including mechanisms
of action, failure rates, contraindications,
potential side effects and complications, and
non-contraceptive benefits.
• Suggest ways of increasing successful
patient utilization of contraceptive methods
• Describe new approaches to older
contraceptive methods.
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What percentages of US pregnancies
are planned and prepared for?
A.
B.
C.
D.
Anita L. Nelson, MD - 4/5/2016 8:38 PM
20%
37%
51%
Unknown
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What percentage of women know
that the risks of thrombosis, diabetes
and hypertension increase in
pregnancy?
A.
B.
C.
D.
Anita L. Nelson, MD - 4/5/2016 8:38 PM
50%
60%
76%
80%
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How many “pill users” get pregnant in
the US each year?
A.
B.
C.
D.
Anita L. Nelson, MD - 4/5/2016 8:38 PM
80,000
240,000
700,000
1,000,000
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Need for Contraception

Pregnancy-related mortality in US 1998-2005

Higher than any other period in prior 20 years
 14.5
per 100,000 live births
 African
American women: 3-4 times higher
rates


Proportion due to bleeding and hypertension
decreased but part due to medical conditions
increased
Data collection change vs. reality?
Berg CJ, et al. Obstet Gynecol. 2010;116:1302
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A Diabetic Baby
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Information From Focus Groups
The concept of “planned pregnancy” is not
meaningful to many women
 Religious beliefs and frameworks help
people accept and, perhaps, rationalize
unintended pregnancy
 Planning for pregnancy is a stressful
concept because of possible
disappointment
 Previous unprotected intercourse without
conception implied infertility

Moos MK, et al. Womens Health Issues. 1997;7:385-392
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PRAMS Survey:
Unintended Pregnancy Reasons
for Unprotected Intercourse
33% thought they could not get pregnant at
that time
 10% thought they or partner were sterile
 30% ambivalent
 22% partner did not want to use
contraceptives
 16% side effects
 10% access problems
 18% other

Nettleman MD. Contraception. 2007;75(5):361-66
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High Typical Use Failure Rates:
First Year Estimates
Injectables:
6.7%
 Oral contraceptives:
8.7%
 Condoms:
17.4%
 Withdrawal:
18.4%
 Fertility awareness methods: 25.3%

Kost K, et al. Contraception. 2008;77(1):10-21
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What Do Women Know About the
Risks of Pregnancy?
Virtually Nothing!
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Women’s Knowledge of
Pregnancy Risks

Survey of 248 women

13.7% correctly identified all the listed health
risks of pregnancy

30% did not know VTE risk rose in pregnancy
49% know risks of VTE, DM and HTN risks in
pregnancy


76% rated pill more hazardous than
pregnancy
Nelson AL, Rezvan A, Contraception. 2012
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Importance of
Contraceptive “Fit”
Contraceptive “fit” – the safest, most
effective birth control method that will
work well for the user
 A good fit depends upon a woman’s


Individual health profile
Lifestyle

Reproductive stage

Preferences

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Tiers of Contraceptive Efficacy
Longer
Term
Implants, IUDs
DMPA Injections
Combined
Vaginal Rings, Transdermal Patches
Hormonal
Oral Contraceptive Pills
Barriers
and
Behaviors
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Male Condoms
Diaphragms, Withdrawal, FAM, NFP
Caps, Female Condoms, Shield
Spermicides
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Etonogestrel Contraceptive Implant

Single implant rod
(4 cm x 2 mm) made of
ethylene vinyl acetate

Contains 68 mg of
etonogestrel
(3-keto-desogestrel)

Effective for 3 years

6 pregnancies in 20,648 cycles

Inhibits ovulation and thickens cervical
mucus

Rapid return of fertility
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Etonogestrel Implant

Provides unsurpassed contraceptive efficacy

By ovulation suppression and thickened
cervical mucus
Very low levels of progestin
 Follicular phase estrogen
 Rare medical contraindications
 Rapid reversibility
 Unpredictably unpredictable bleeding
 Weight changes less well tolerated

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Etonogestrel Implant: Bleeding Patterns
US Data
n=330
Data on file, Organon Inc. Study Report 069001.
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Copper T 380
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Copper T 380 IUD
Net cumulative rates (%)
by year
1
2
3
4
7
10
1.8
2.3
2.7
Pregnancy
0.7 1.0
1.6
Expulsion
5.7
9.8 11.0 11.9 14.2
8.2
Bleeding/pain 11.9 21.7 28.7 32.2 41.6 50.0
Other medical
events
2.5
4.6
6.2
7.9 9.3
10.1
Prescribing Information. 2005
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Copper Intrauterine Devices
Mechanisms of Action
Interference with sperm transport from cervix
to fallopian tube
 Inhibition of sperm capacitation or survival


Viable sperm scarce in fallopian tubes of IUD
users
Inhibition of fertilization: no normally dividing
fertilized ova in tubes or uterus
 Not an abortifacient

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Condition of Ova Recovered From
Fallopian Tubes at Ovulation
Group
Control
Uncertain Or
Normal
No
Abnormal
Develop- DevelopDevelopment
ment
ment
10
3
7
0
9
5
Lippes loop
0
3
1
TCu 200
0
2
3
Progestin IUD
0
4
1
All IUDs
Alvarez F, et al. Fertil Steril. 1988;49(5):768-73
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32 mm
Levonorgestrel-Releasing
Intrauterine System (LNG IUS)
Steroid
reservoir
Levonorgestrel
20 mcg/day
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LNG IUS Typical Use
Failure Rates (Pearl Index)
First year
0.14%
 5-year cumulative
0.71%
 Meta-analysis of comparative clinical trials
showed no differences in efficacy compared
to copper IUDs with ≥ 250 mm2 copper

Anderson K, et al. Contraception. 1994;49:56
Luukkainen T, et al. Contraception. 1987;36:169
French RS, et al. Br J Obstet Gynecol. 2000;107:1218-25
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LNG IUS:
Mechanisms of Action
Thickened cervical mucus
 Sperm motility and function impaired
 Weak foreign body reaction (spermicide)
 Fertilization inhibited (glycodelin-A)
 Ovulation inhibited




55% first year
25% in 5th year
Endometrium suppressed
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Cervical Mucus
Lewis RA, et al. Fertil Steril, 2009 Sep;92(3) Suppl: S27
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Median Menstrual Blood Loss
(MBL)
160
Median MBL (mL)
140
120
100
80
Mirena®
MPA
60
40
20
0
Baseline
3 Month
6 Month
Nelson AL. Presented at XIX FIGO World Congress, So Africa, Oct 2009
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DMPA in Real Life

First year failure rates



Correct and consistent use: 0.3%
Typical use: 7.4%
In study of 160,000 new start DMPA users, 1
 56.6%
 21%

returned on time for first refill
returned on time for all 3 refills
Emphasizes need for Quick Start protocols 2
1 Nelson
AL et al Obstet Gynecol 2008 112(4):782-7
2 Nelson
AL et al Contraception 2007 75(2):84-7
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DMPA Practice Recommendation to
Increase Access and Success





No pelvic exam or pap smear needed prior to initiation
Quick Start for initiation and late re-injection1
No pregnancy test needed prior to any injection unless
the patient has had unprotected intercourse or has
symptoms of pregnancy
Always provide EC because patients can return late for
reinjection
Reinjection without need of pregnancy testing or back
up method may be routinely extended by 2-4 weeks.2
1 Nelson AL, et al. Contraception. 2007 (75(2):84-7
2 Steiner MJ, et al. Contraception. 2008;77(6):410-4
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Possible Treatments for
Unscheduled DMPA Bleeding

Estradiol vaginal ring for first 3 months of DMPA
 Reduced unscheduled bleeding
 Increased continuation rates
 Transitioning from COCs to DMPA
 Reduced bleeding in first 6 months
 14 day treatment with 50 mcg EE or 2.5 mg ES
 Reduced bleeding in 93% and 78% of cases


Placebo reduced by 74 %
No long term difference in bleeding or
continuation rates
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DMPA and Bone Density
ACOG Committee Study
“Concerns regarding the effect of DMPA and
BMD (bone mineral density) should neither
prevent practitioners from prescribing DMPA
nor limit its use to 2 consecutive years”1
 Bone loss reversed in 2-3 years2

1. ACOG Committee Opinion No. 415,Sept 2008
2. Harel Z et al. Contraception. 2010 81(4):281-91
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DMPA-SC: Treatment for Endometriosis Pain
Prescribing Information. 2005
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Oral Contraceptive Pills

Safe and well-tested -- the gold standard:


50 years of clinical experience in US
Best studied medication in history
Failure rate with consistent and correct use
< 1%
 Typical first year failure rate is 8.7%
 Rapidly reversible:



Only 2 week average delay in fertility
Extensive non-contraceptive benefits
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“Birth control pills are not
dangerous, but there are dangerous
women out there. Find them and
keep them away from the pill, and
the pill will do its work well.”
Paul Brenner, M.D.
Professor, OB-GYN
USC
Pregnancy is hazardous to a woman’s health
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Pill Safety: 39 Year Follow-up

46,112 women followed for up to 39 years



378,006 women-years in never-users
819,175 women-years in ever-users
Significantly lower rate of death in prior
OC users from:



Any cause (12% reduction)
All cancers
All circulatory diseases, ischemic heart
disease, and all other diseases
Hannaford PC, et al. BMJ. 2010 340:c927
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Streamlined Prescribing Practices to Improve
Access and Success with Hormonal
Contraceptives

No pelvic exam needed


Same Day/Quick Start protocols






Pregnancy test only if unprotected intercourse since LMP
EC now if unprotected intercourse in last 5 days
Start first pill/patch/ring now or in 12 hours
Back up method (condoms) 7 days
Provide several month supply of method
Provide condoms for use if stops pills, etc.


If need to screen for STD, use urine tests
Teach her how to use them!
Give EC by advance prescription

Accidents will happen
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OC Failure by Body Weight >70.5 kg
and OC Estrogen Dose
Dose EE
Pregnancy RR
95% CI
 50 µg
1.2
0.4 – 3.5
< 50 µg
2.6
1.2 – 5.9
< 35 µg
4.5
1.4 – 14.4
1. Holt VL, et al. Obstet Gynecol. 2005;105(1):46-52
2. Holt VL, et al. Obstet Gynecol. 2002;99(5 Pt 1):820-7
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Pharmacokinetic Studies





No difference in volume of distribution for
levonorgestrel or EE
 Obese or normal-weight women
LNG requires twice as long to reach steady state
 LNG half-life twice as long in obese women
 Obese women may benefit from shorter pill free
interval
Greater ovarian follicular activity in obese women
Trough levels unaffected by obesity
Remaining questions: Peak values or trough levels
most important? Is cervical mucus affected?
Edelman AB, et al. Contraception 2009;80:119-127
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Obesity and COC Efficacy:
Westhoff 20/30 Trial
226 women BMI 19-24.5 vs 30-39.9
 Obesity is associated with higher risk of
ovulation but…
 Obese women were 3.1 times more likely to
be noncompliant



17% never took any pills but said they were
using them consistently
Follicular development, endogenous E2
levels and ovulation suppression equivalent
among consistent users
Westhoff CL, et al. Obstet Gynecol. 2010;116:275-83
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Efficacy 21/7 vs 24/4

Outcome 52,218 US women; 73,269 women-yrs
in active surveillance program
Dinger J, et at. Obstet Gynecol, 2011;117:33-40
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New Missed Pills Rules
Take last pill missed + today’s pill
Missed 1 Pill
Missed 2+ pills
Missed pills in last
week of pack?
Continue taking rest
of pills as usual
No additional
contraception needed
No
Continue taking
rest of pills as
usual
Yes
Take rest of active pills in
pack, skip placebos, start
new pack immediately
Add another method
for 7 days
EC if missed pills within first week and
unprotected coitus in previous 7 days
Add
another
method for 7 days
No EC (?)
Mansour D. J Fam Plann. 2011; (37):128-31
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How Many Pill Packs…

California Family PACT: 84,401 women
Pregnancy

1
Cycle
3
Cycles
13
Cycles
2.9%
3.3%
1.2%
Abortion rates also 46% less when women
given 1 year supply
Foster DG, et al. Obstet Gynecol. 2011;117:566-72
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New COC Formulations

Extra Minerals



Beyaz 24 tablets: 20 mcg EE + 3 mg
drospirenone + 0.451 mg levomefolate
calcium
Lo Loestrin Fe: 24 tablets 10 mcg EE + 1 mg
norethindrone acetate; 2 tablets 10 mcg EE;
2 tablets 75 mg ferrous fumarate
Natazia : 4-phasic formulation


Estradiol valerate + dienogest
Fewer bleeding/spotting days vs. 20 mcg
EE/LNG pill
Ahrendt H, et al. Contraception. 2009;80(5):436-44
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Non-Contraceptive Health Benefits
of Oral Contraceptives
Proven Reduction in Risk:
 Ovarian Cancer
 Endometrial Cancer
 Pelvic Inflammatory
Disease
 Ectopic Pregnancy
 Benign Breast Disease
 Menorrhagia
 Dysmenorrhea
 Iron Deficiency Anemia
 Low Bone Density
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Possible Reduction in Risk:
l Cardiovascular Disease
l Uterine Fibroids
l Endometriosis
l Rheumatoid Arthritis
Adapted from: Ory HW.
Fam Plann Perspect.
1982;14:182-4
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Percent Lesion Reduction
Reduction in Total Acne Lesions
Tri-NGM
Placebo
Cycle
Both groups had daily hygiene.
Cycles 2-6: P<0.0001
Redmond et al. Obstet Gynecol. 1997;89:615-22
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Data displayed as:
Triphasic
N (%) Norgestimate/EE
(N=228)
Headache
42 (18.4)
Nausea
29 (12.7)
Dysmenorrhea
23 (10.1)
Breast pain
21 ( 9.2)
Abdominal pain
13 ( 5.7)
Back pain
13 ( 5.7)
Vomiting
8 ( 3.5)
Breast enlargement
6 ( 2.6)
Emotional lability
6 ( 2.6)
Weight gain
5 ( 2.2)
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Placebo
(N=234) p-value
48 (20.5) 0.639
21 ( 9.0) 0.231
21 ( 9.0) 0.752
11 ( 4.7) 0.067
9 ( 3.9) 0.270
8 ( 3.4) 0.597
6 ( 2.6) 0.597
3 ( 1.3) 0.333
1 ( 0.4) 0.065
5 ( 2.1) 1.000
Redmond et al.
Contraception. 1999;60:81-5
Incidence of Events Commonly
Attributable to OC Use
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Impact of Inappropriate Warning
Nocebo or Noise?
In original OC trials for menstrual irregularity,
counseling women about OC side effects
increased their incidence in placebo users
 “Because Level 1 evidence documents no
important increase in nonspecific side effects
with oral contraceptives, counseling about
these side effects or including those in
package labeling is unwarranted and
probably unethical.”1

1. Grimes DA, et al. Contraception. 2011;83:5-9
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Hormone-Withdrawal Symptoms
in OC Users
Symptoms
Pelvic pain
Headaches
Breast
tenderness
Bloating/swelling
Use of pain
medications
Hormone
HormoneTreatment %
Free %
(21 days)
(7 days) p-value
21
70
<0.001
53
70
<0.001
19
58
<0.001
16
43
38
69
<0.001
<0.001
Sulak P, et al. Obstet Gynecol. 2000;95:261–6
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Counseling Points for Women
Considering Extended Cycle

Validate patient’s beliefs in need for monthly
menses without hormonal contraception

Absence could be sign of pregnancy, hormonal
imbalances, endocrinopathy or risk for cancer.

Menses represents reproductive failure. A clean up
operation to prepare for better luck next cycle.
 Dispel her concerns proactively




Blood not building up
Ovaries not swelling
Fertility will return (not menopausal)
Cancer risk not increased
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Oral Contraceptives: Quick Start

With conventional start of OCs, up to 25% of
women do not start their pills due to:





Pregnancy
Change in method
Confusion about pill instructions
Fear of possible side effects
Quick start with OCs protocol



Start with first pill in pack
Provide backup method for 7 days
Provide EC if indicated
Westhoff CW, et al. Fertil Steril. 2003;79:322-9
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Pelvics Needed Before Pills?
10 years ago RTC demonstrated pelvic exam
not needed,1 and posed a barrier2
 ACOG and WHO require only weight, BP,
and health history
 Survey 2008-9 with 65.3% response rate:3


Still require pelvic exams:
MD
APN
Ob-Gyn Family Women’s Family
29%
33%
17%
45%
1. Stewart FH, et al. JAMA. 2001;285:2232-9
2. Harper C, et al. Fam Plann Perspect. 2001;33:13-18
3. Henderson JT, et al. Obstet Gynecol. 2010;116:1257-64
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Percentage of Women (%)
Oral Contraceptive Compliance:
Number of Active Pills Missed
Potter L, et al. Fam Plann Perspect. 1996;28:154-8
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Application of Contraceptive Patch on Abdomen
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% Compliant Cycles
Contraceptive Patch:
Successful Utilization by Age Group
P<0.001
P<0.001
P<0.001
P<0.008
P<0.006
P<0.005
Age (years)
Archer D, et al. Contraception. 2004;69(3):189-95
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Comparator OC
OR (95% CI)
Patch vs NGM/35 EE Pill
0.9 (0.5-1.6)1
Patch vs NGM/35 EE Pill
1.1 (0.6-2.1)2
Patch vs NGM/35 EE Pill
All users
New initiators
2.2 (1.3-3.8)3
2.2 (0.8-6.1)3
Patch vs NGM/35 EE Pill +24 mo.
All users
New initiators
2.0 (1.2-3.3)4
1.8 (0.8-3.8)4
Patch vs LNG/35 mcg EE
2.0 (0.9-4.1)5
VTE = venous thromboembolism; OR = odds ratio
NGM = norgestimate; EE = ethinyl estradiol; LNG = levonorgestrel
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1. Jick SS, et al. Contraception. 2006;73(3):223-8
2. Jick S, et al. Contraception. 2007;76(1):4-7
3. Cole JA, et al. Obstet Gynecol. 2007;109(2):339-46
4. Dore DD, et al. Contraception. 2010; 85(5):408-13
5.Jick SS et al. Contraception. 2010;81(1):16-21
VTE Risk of Patch vs OCs
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Contraceptive Vaginal Ring

Very low dose

120 mcg/day etonogestrel

15 mcg/day ethinyl estradiol
Flexible
 Transparent
 Outer diameter: 54 mm
 Thickness: 4 mm
 One ring per cycle: 3 weeks ring-in
1 week ring-free

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Contraceptive Vaginal Ring
Advantages







A monthly method
Easily placed by the woman
Discreet
Lowest EE dose (15 µg/day)
Constant serum concentrations
Avoids GI interference with absorption
Avoids hepatic first-pass metabolism
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Contraceptive Vaginal Ring
Placement
No incorrect way to insert
contraceptive vaginal ring
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Contraceptive Vaginal Ring
versus 30 mcg OC: Cycle Control
Cycle
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Quick Start Ring vs Pill: Bleeding Patterns
84-day
Reference Period
Bleeding-spotting
days
Bleeding-only days
Spotting-only days
Bleeding-spotting
episodes
Bleeding-spotting
episode days
Bleeding-spottingfree interval days
Ring
Pill
(n = 78 ) (n = 78) Diff.
95% CI
14.5
19.2
4.7
2.1,7.3
9.1
5.4
11.9
7.3
2.8
1.9
1.1,4.5
0.18,3.7
2.4
3.0
0.58 0.24,0.92
6.0
6.5
0.50 -0.28,1.2
21.2
19.0
-2.2 -4.3,-0.03
Westhoff C, et al. Obstet Gynecol. 2005;106(1):89-96
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New Developments in
Hormonal Contraception
New lower-dose patch in clinical trials
 New vaginal ring (12 months with new
progestin)
 Triphasic extended-cycle pills
 New progestin-only pills

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Remember Progestin Only Pill
The Go-To Pill!

US MEC: only one category 4 condition


Efficacy in typical use rated equivalent to
estrogen containing OCs


Recent breast cancer (in last 5 years)
No studies of efficacy of US POPs since
1960s
Remaining perceptions of POPs (no data)


Higher rates of unscheduled bleeding or
spotting
Higher rates of discontinuation
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“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
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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 Dec;82(6) 489-90
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Male Condom

Typical first year failure rate: 17.4%


Advantages:




Range 2-20%
Male participation
Inexpensive
Readily available


Protects well against STDs
Cervical dysplasia reduced
Special applications:



Premature ejaculation
Antisperm antibody
Female allergy to sperm
Kost K, et al. Contraception. 2008;77(1):10-21
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Polyurethane Condom
Polyurethane
Latex
Breakage & slippage, 1997
8.5%
1.6%
Breakage & slippage, 1990
10.5%
1.7%
Breakage
66/1804
7/1882
Slippage
6/1804
1/1882
Uncorrected pregnancy rate
4.6 (2.6)
6.1 (1.0)
Corrected pregnancy rate
5.3 (3.1)
6.5 (1.2)
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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
1
2
3
4
5*
More than 5 *
All
# women who
had coitus
48
34
35
28
29
43
217
% used condoms
consistently
67%
65%
66%
61%
38%
40%
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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Male Condoms: Sizes

Snug fitting


Larger size—more headroom


Beyond7, Studded Beyond 7, Exotica Snugger Fit,
LifeStyles Snugger Fit, Trojan Ultra Fit
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 Sizes

French clinical condom trial, 2003:


US Survey 2009: 1661 men





39% said latex condom too small or too large
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 Dec;82(6) 489-90
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Female Barrier Methods
Failure Rates
Perfect Use
Users
Typical
Nulliparous Parous
All
Use
Diaphragm
no difference
5.2-6.9
16-18
Spermicide
no difference
6
18-21
Female
Condom
unknown
3
21-25
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FemCap
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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

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Female Condom – Take 2: FC2

Made of nitrile, 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 June;34:26-9
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Cycle Beads

Color coded string of beads helps women
identify days of cycle pregnancy is likely
and unlikely
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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

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Coitus Interuptus
Typical failure rate 18.4% - on par with
female barrier method failure rates
 Counseling critically important




sexual practices
pinch techniques
what to do about the woman after …
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THE EVENING AFTER THE DAY FOLLOWING
THE MORNING AFTER THE NIGHT BEFORE PILL
EMERGENCY CONTRACEPTION
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LNG EC Products

Plan B® One-Step




1.5 mg levonorgestrel in 1 table to be taken within
72 hours (on label)
Available without a prescription to people aged 17
and older with government identification
Available with prescription to women of all ages
Plan B now to be available as generic product
named Next ChoiceTM from Watson


Available without a prescription to people age 17
and older with government identification
Available with a prescription to women of all ages
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How Long After the Morning After?
WHO Pooled Data (Yuzpe and LNg), 1998
Piaggio G, et al. Lancet. 1999;353:721
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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
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Ulipristal Acetate CDB-2914

Selective progesterone receptor modulator

50 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 Feb;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 Feb;115(2 Pt 1):257-63
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Overweight and Obese Women Have
Higher EC Failure Rates
Pregnancy Rates
BMI
LNG-EC
UPA-EC
< 25 kg/m2
13.9%
15.6%
25 - 29.9 kg/m2
≥ 30 kg/m2
2.5%
28.6%
1.1%
38.7%
Glaiser A, et al. Contraception. 2011;In Press
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Copper IUD for EC
8400 postcoital copper IUD placements 1
 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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Summary of Recommendations
(PEARLS)






Find out what she will use
Make it attractive to her
Start it now
Give EC now, and for future use
Give lots of cycles of contraception
Give backup method


Her back up method becomes primary method if
she discontinues her first choice method
Encourage her to plan and prepare for future
pregnancy
NOW and LOTS and MORE
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DON’T EVER GIVE UP!
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