Contraceptive Update

35th Annual CAPA Conference

Palm Spring, CA

September 22 – September 25, 2011

Anita L. Nelson, MD

Harbor-UCLA Medical Center

Anita L. Nelson, MD - 04/19/23 12:16 2CT 2011-09-25 CAPA Palm Springs

Conflict of Interest DisclosureAnita L. Nelson, MD

Grants/Research

Bayer,

Merck, Pfizer, Teva

Honoraria/Speakers Bureau

Bayer,

Merck, Pfizer, Teva

Consultant/Advisory Board

Bayer, Merck, Teva

Anita L. Nelson, MD - 04/19/23 12:16 3CT 2011-09-25 CAPA Palm Springs

Learning Objectives

At the end of this presentation, theparticipant 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.

Anita L. Nelson, MD - 04/19/23 12:16 4CT 2011-09-25 CAPA Palm Springs

What percentages of US pregnancies are planned and prepared for?

A. 20%

B. 37%

C. 51%

D. Unknown

Anita L. Nelson, MD - 04/19/23 12:16 5CT 2011-09-25 CAPA Palm Springs

What percentage of women know that the risks of thrombosis, diabetes

and hypertension increase in pregnancy?

A. 50%

B. 60%

C. 76%

D. 80%

Anita L. Nelson, MD - 04/19/23 12:16 6CT 2011-09-25 CAPA Palm Springs

How many “pill users” get pregnant in the US each year?

A. 80,000

B. 240,000

C. 700,000

D. 1,000,000

Anita L. Nelson, MD - 04/19/23 12:16 8CT 2011-09-25 CAPA Palm Springs

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 birthsAfrican 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

Anita L. Nelson, MD - 04/19/23 12:16 9CT 2011-09-25 CAPA Palm Springs

A Diabetic Baby

Anita L. Nelson, MD - 04/19/23 12:16 10CT 2011-09-25 CAPA Palm Springs

Anita L. Nelson, MD - 04/19/23 12:16 11CT 2011-09-25 CAPA Palm Springs

Information From Focus GroupsThe concept of “planned pregnancy” is not

meaningful to many womenReligious 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

Anita L. Nelson, MD - 04/19/23 12:16 12CT 2011-09-25 CAPA Palm Springs

PRAMS Survey: Unintended Pregnancy Reasons

for Unprotected Intercourse33% thought they could not get pregnant at

that time10% thought they or partner were sterile30% ambivalent22% partner did not want to use

contraceptives16% side effects10% access problems18% other

Nettleman MD. Contraception. 2007;75(5):361-66

Anita L. Nelson, MD - 04/19/23 12:16 13CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 14CT 2011-09-25 CAPA Palm Springs

What Do Women Know About the Risks of Pregnancy?

Virtually Nothing!

Anita L. Nelson, MD - 04/19/23 12:16 15CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 16CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 17CT 2011-09-25 CAPA Palm Springs

Tiers of Contraceptive Efficacy

LongerTerm

Implants, IUDs

CombinedHormonal

DMPA Injections

Vaginal Rings, Transdermal Patches

Oral Contraceptive Pills

Barriersand

Behaviors

Male Condoms

Diaphragms, Withdrawal, FAM, NFP

Caps, Female Condoms, Shield

Spermicides

Anita L. Nelson, MD - 04/19/23 12:16 18CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 19CT 2011-09-25 CAPA Palm Springs

Etonogestrel Implant

Provides unsurpassed contraceptive efficacy By ovulation suppression and thickened

cervical mucusVery low levels of progestin Follicular phase estrogenRare medical contraindicationsRapid reversibilityUnpredictably unpredictable bleedingWeight changes less well tolerated

Anita L. Nelson, MD - 04/19/23 12:16 20CT 2011-09-25 CAPA Palm Springs

Etonogestrel Implant: Bleeding Patterns

Data on file, Organon Inc. Study Report 069001.

US Data n=330

Anita L. Nelson, MD - 04/19/23 12:16 21CT 2011-09-25 CAPA Palm Springs

Copper T 380

Anita L. Nelson, MD - 04/19/23 12:16 22CT 2011-09-25 CAPA Palm Springs

Copper T 380 IUDNet cumulative rates (%)

by year

1 2 3 4 7 10

Pregnancy 0.7 1.0 1.6 1.8 2.3 2.7

Expulsion 5.7 8.2 9.8 11.0 11.9 14.2

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

Anita L. Nelson, MD - 04/19/23 12:16 23CT 2011-09-25 CAPA Palm Springs

Copper Intrauterine DevicesMechanisms 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

usersInhibition of fertilization: no normally dividing

fertilized ova in tubes or uterusNot an abortifacient

Anita L. Nelson, MD - 04/19/23 12:16 24CT 2011-09-25 CAPA Palm Springs

Condition of Ova Recovered From Fallopian Tubes at

Ovulation

Group

Normal Develop-

ment

No Develop-

ment

Uncertain Or Abnormal Develop-

ment

Control 10 3 7

All IUDs 0 9 5

Lippes loop 0 3 1

TCu 200 0 2 3

Progestin IUD 0 4 1

Alvarez F, et al. Fertil Steril. 1988;49(5):768-73

Anita L. Nelson, MD - 04/19/23 12:16 25CT 2011-09-25 CAPA Palm Springs

Levonorgestrel-Releasing Intrauterine System (LNG IUS)

Levonorgestrel 20 mcg/day

32 m

m

Steroid reservoir

Anita L. Nelson, MD - 04/19/23 12:16 26CT 2011-09-25 CAPA Palm Springs

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;49:56Luukkainen T, et al. Contraception. 1987;36:169French RS, et al. Br J Obstet Gynecol. 2000;107:1218-25

Anita L. Nelson, MD - 04/19/23 12:16 27CT 2011-09-25 CAPA Palm Springs

LNG IUS: Mechanisms of Action

Thickened cervical mucusSperm motility and function impairedWeak foreign body reaction (spermicide)Fertilization inhibited (glycodelin-A)Ovulation inhibited

55% first year 25% in 5th year

Endometrium suppressed

Anita L. Nelson, MD - 04/19/23 12:16 28CT 2011-09-25 CAPA Palm Springs

Cervical Mucus

Lewis RA, et al. Fertil Steril, 2009 Sep;92(3) Suppl: S27

Anita L. Nelson, MD - 04/19/23 12:16 29CT 2011-09-25 CAPA Palm Springs

Median Menstrual Blood Loss (MBL)

0

20

40

60

80

100

120

140

160M

edia

n M

BL

(m

L)

Baseline 3 Month 6 Month

Mirena®

MPA

Nelson AL. Presented at XIX FIGO World Congress, So Africa, Oct 2009

Anita L. Nelson, MD - 04/19/23 12:16 30CT 2011-09-25 CAPA Palm Springs

DMPA in Real LifeFirst 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% returned on time for first refill21% returned on time for all 3 refills

Emphasizes need for Quick Start protocols 2

2 Nelson AL et al Contraception 2007 75(2):84-7

1 Nelson AL et al Obstet Gynecol 2008 112(4):782-7

Anita L. Nelson, MD - 04/19/23 12:16 31CT 2011-09-25 CAPA Palm Springs

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):84-72 Steiner MJ, et al. Contraception. 2008;77(6):410-4

Anita L. Nelson, MD - 04/19/23 12:16 32CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 33CT 2011-09-25 CAPA Palm Springs

DMPA and Bone DensityACOG 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 20082. Harel Z et al. Contraception. 2010 81(4):281-91

Anita L. Nelson, MD - 04/19/23 12:16 34CT 2011-09-25 CAPA Palm Springs

DMPA-SC: Treatment for Endometriosis Pain

Prescribing Information. 2005

Anita L. Nelson, MD - 04/19/23 12:16 35CT 2011-09-25 CAPA Palm Springs

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 fertilityExtensive non-contraceptive benefits

Anita L. Nelson, MD - 04/19/23 12:16 36CT 2011-09-25 CAPA Palm Springs

“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-GYNUSC

Pregnancy is hazardous to a woman’s health

Anita L. Nelson, MD - 04/19/23 12:16 37CT 2011-09-25 CAPA Palm Springs

Pill Safety: 39 Year Follow-up46,112 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

Anita L. Nelson, MD - 04/19/23 12:16 38CT 2011-09-25 CAPA Palm Springs

Streamlined Prescribing Practices to Improve Access and Success with Hormonal

Contraceptives No pelvic exam needed

If need to screen for STD, use urine tests 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.

Teach her how to use them! Give EC by advance prescription

Accidents will happen

Anita L. Nelson, MD - 04/19/23 12:16 39CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 40CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 41CT 2011-09-25 CAPA Palm Springs

Obesity and COC Efficacy:Westhoff 20/30 Trial

226 women BMI 19-24.5 vs 30-39.9Obesity 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 consistentlyFollicular development, endogenous E2

levels and ovulation suppression equivalent among consistent users

Westhoff CL, et al. Obstet Gynecol. 2010;116:275-83

Anita L. Nelson, MD - 04/19/23 12:16 42CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 43CT 2011-09-25 CAPA Palm Springs

New Missed Pills Rules

Take last pill missed + today’s pill

Missed 2+ pillsMissed 1 Pill

Continue taking rest of pills as usual YesNo

Missed pills in last week of pack?

Continue taking rest of pills as

usual

Take rest of active pills in pack, skip placebos, start new pack immediately

No additional contraception needed

Add another method for 7 days

Add another method for 7 days

No EC (?)EC if missed pills within first week and unprotected coitus in previous 7 days

Mansour D. J Fam Plann. 2011; (37):128-31

Anita L. Nelson, MD - 04/19/23 12:16 44CT 2011-09-25 CAPA Palm Springs

How Many Pill Packs…

California Family PACT: 84,401 women

Abortion rates also 46% less when women given 1 year supply

1 Cycle

3 Cycles

13 Cycles

Pregnancy 2.9% 3.3% 1.2%

Foster DG, et al. Obstet Gynecol. 2011;117:566-72

Anita L. Nelson, MD - 04/19/23 12:16 45CT 2011-09-25 CAPA Palm Springs

New COC FormulationsExtra 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 pillAhrendt H, et al. Contraception. 2009;80(5):436-44

Anita L. Nelson, MD - 04/19/23 12:16 46CT 2011-09-25 CAPA Palm Springs

Non-Contraceptive Health Benefitsof 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

Possible Reduction in Risk: Cardiovascular Disease Uterine Fibroids Endometriosis Rheumatoid Arthritis

Adapted from: Ory HW. Fam Plann Perspect.

1982;14:182-4

Anita L. Nelson, MD - 04/19/23 12:16 47CT 2011-09-25 CAPA Palm Springs

Reduction in Total Acne LesionsP

erce

nt

Les

ion

Red

uct

ion

Cycle

Cycles 2-6: P<0.0001

Tri-NGM

Placebo

Redmond et al. Obstet Gynecol. 1997;89:615-22

Both groups had daily hygiene.

Anita L. Nelson, MD - 04/19/23 12:16 48CT 2011-09-25 CAPA Palm Springs

Incidence of Events Commonly Attributable to OC Use

Re

dm

on

d e

t al.

Co

ntr

ace

ptio

n. 1

99

9;6

0:8

1-5

Data displayed as:N (%)

TriphasicNorgestimate/EE

(N=228)Placebo(N=234) p-value

Headache 42 (18.4) 48 (20.5) 0.639

Nausea 29 (12.7) 21 ( 9.0) 0.231

Dysmenorrhea 23 (10.1) 21 ( 9.0) 0.752

Breast pain 21 ( 9.2) 11 ( 4.7) 0.067

Abdominal pain 13 ( 5.7) 9 ( 3.9) 0.270

Back pain 13 ( 5.7) 8 ( 3.4) 0.597

Vomiting 8 ( 3.5) 6 ( 2.6) 0.597

Breast enlargement 6 ( 2.6) 3 ( 1.3) 0.333

Emotional lability 6 ( 2.6) 1 ( 0.4) 0.065

Weight gain 5 ( 2.2) 5 ( 2.1) 1.000

Anita L. Nelson, MD - 04/19/23 12:16 49CT 2011-09-25 CAPA Palm Springs

Impact of Inappropriate WarningNocebo 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

Anita L. Nelson, MD - 04/19/23 12:16 50CT 2011-09-25 CAPA Palm Springs

Hormone-Withdrawal Symptoms in OC Users

Symptoms

Hormone Treatment %

(21 days)

Hormone- Free %(7 days) p-value

Pelvic pain 21 70 <0.001

Headaches 53 70 <0.001

Breast tenderness

19 58 <0.001

Bloating/swelling 16 38 <0.001

Use of painmedications

43 69 <0.001

Sulak P, et al. Obstet Gynecol. 2000;95:261–6

Anita L. Nelson, MD - 04/19/23 12:16 51CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 52CT 2011-09-25 CAPA Palm Springs

Oral Contraceptives: Quick StartWith 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

Anita L. Nelson, MD - 04/19/23 12:16 53CT 2011-09-25 CAPA Palm Springs

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;285:2232-92. Harper C, et al. Fam Plann Perspect. 2001;33:13-183. Henderson JT, et al. Obstet Gynecol. 2010;116:1257-64

Anita L. Nelson, MD - 04/19/23 12:16 54CT 2011-09-25 CAPA Palm Springs

Oral Contraceptive Compliance:Number of Active Pills Missed

Per

cen

tag

e o

f W

om

en (

%)

Potter L, et al. Fam Plann Perspect. 1996;28:154-8

Anita L. Nelson, MD - 04/19/23 12:16 55CT 2011-09-25 CAPA Palm Springs

Application of Contraceptive Patch on Abdomen

Anita L. Nelson, MD - 04/19/23 12:16 56CT 2011-09-25 CAPA Palm Springs

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)

% C

om

plia

nt

Cyc

les

Archer D, et al. Contraception. 2004;69(3):189-95

Anita L. Nelson, MD - 04/19/23 12:16 57CT 2011-09-25 CAPA Palm Springs

VTE Risk of Patch vs OCsComparator OC OR (95% CI)

Patch vs NGM/35 EE Pill0.9 (0.5-1.6)1

Patch vs NGM/35 EE Pill1.1 (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 ratioNGM = norgestimate; EE = ethinyl estradiol; LNG = levonorgestrel

Anita L. Nelson, MD - 04/19/23 12:16 58CT 2011-09-25 CAPA Palm Springs

Contraceptive Vaginal Ring

Very low dose 120 mcg/day etonogestrel 15 mcg/day ethinyl estradiol

FlexibleTransparentOuter diameter: 54 mmThickness: 4 mmOne ring per cycle: 3 weeks ring-in

1 week ring-free

Anita L. Nelson, MD - 04/19/23 12:16 59CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 60CT 2011-09-25 CAPA Palm Springs

Contraceptive Vaginal Ring Placement

No incorrect way to insert contraceptive vaginal ring

Anita L. Nelson, MD - 04/19/23 12:16 61CT 2011-09-25 CAPA Palm Springs

Contraceptive Vaginal Ring versus 30 mcg OC: Cycle Control

Cycle

Anita L. Nelson, MD - 04/19/23 12:16 62CT 2011-09-25 CAPA Palm Springs

Quick Start Ring vs Pill: Bleeding Patterns

84-day Reference Period

Ring(n = 78 )

Pill(n = 78) Diff. 95% CI

Bleeding-spottingdays

14.5 19.2 4.7 2.1,7.3

Bleeding-only days 9.1 11.9 2.8 1.1,4.5

Spotting-only days 5.4 7.3 1.9 0.18,3.7

Bleeding-spottingepisodes

2.4 3.0 0.58 0.24,0.92

Bleeding-spotting episode days

6.0 6.5 0.50 -0.28,1.2

Bleeding-spotting-free interval days

21.2 19.0 -2.2 -4.3,-0.03

Westhoff C, et al. Obstet Gynecol. 2005;106(1):89-96

Anita L. Nelson, MD - 04/19/23 12:16 63CT 2011-09-25 CAPA Palm Springs

New Developments in Hormonal Contraception

New lower-dose patch in clinical trialsNew vaginal ring (12 months with new

progestin)Triphasic extended-cycle pillsNew progestin-only pills

Anita L. Nelson, MD - 04/19/23 12:16 64CT 2011-09-25 CAPA Palm Springs

Remember Progestin Only PillThe Go-To Pill!

US MEC: only one category 4 condition Recent breast cancer (in last 5 years)

Efficacy in typical use rated equivalent to estrogen containing OCs No studies of efficacy of US POPs since

1960sRemaining perceptions of POPs (no data)

Higher rates of unscheduled bleeding or spotting

Higher rates of discontinuation

Anita L. Nelson, MD - 04/19/23 12:16 65CT 2011-09-25 CAPA Palm Springs

“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

Anita L. Nelson, MD - 04/19/23 12:16 66CT 2011-09-25 CAPA Palm Springs

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 Dec;82(6) 489-90

Anita L. Nelson, MD - 04/19/23 12:16 67CT 2011-09-25 CAPA Palm Springs

Male CondomTypical first year failure rate: 17.4%

Range 2-20%Advantages:

Male participation Protects well against STDs Inexpensive 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

Anita L. Nelson, MD - 04/19/23 12:16 68CT 2011-09-25 CAPA Palm Springs

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)

Anita L. Nelson, MD - 04/19/23 12:16 69CT 2011-09-25 CAPA Palm Springs

The Male Condom

Anita L. Nelson, MD - 04/19/23 12:16 70CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 71CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 72CT 2011-09-25 CAPA Palm Springs

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 Dec;82(6) 489-90

Anita L. Nelson, MD - 04/19/23 12:16 73CT 2011-09-25 CAPA Palm Springs

Female Barrier MethodsFailure Rates

Perfect Use Typical

Users 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

Anita L. Nelson, MD - 04/19/23 12:16 74CT 2011-09-25 CAPA Palm Springs

FemCap

Anita L. Nelson, MD - 04/19/23 12:16 75CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 76CT 2011-09-25 CAPA Palm Springs

Female Condom – Take 2: FC2Made 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 CondomNational Sensation Panty Condom

Schwartz J. The Female Patient. 2009 June;34:26-9

Anita L. Nelson, MD - 04/19/23 12:16 78CT 2011-09-25 CAPA Palm Springs

Cycle BeadsColor coded string of beads helps women

identify days of cycle pregnancy is likely and unlikely

Anita L. Nelson, MD - 04/19/23 12:16 79CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 80CT 2011-09-25 CAPA Palm Springs

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 …

Anita L. Nelson, MD - 04/19/23 12:16 81CT 2011-09-25 CAPA Palm Springs

THE EVENING AFTER THE DAY FOLLOWING THE MORNING AFTER THE NIGHT BEFORE PILL EMERGENCY CONTRACEPTION

Anita L. Nelson, MD - 04/19/23 12:16 82CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 83CT 2011-09-25 CAPA Palm Springs

How Long After the Morning After?WHO Pooled Data (Yuzpe and LNg), 1998

Piaggio G, et al. Lancet. 1999;353:721

Anita L. Nelson, MD - 04/19/23 12:16 84CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 85CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 86CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 87CT 2011-09-25 CAPA Palm Springs

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 2.5% 1.1%

≥ 30 kg/m2 28.6% 38.7%

Glaiser A, et al. Contraception. 2011;In Press

Anita L. Nelson, MD - 04/19/23 12:16 88CT 2011-09-25 CAPA Palm Springs

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%

3 Bilian X. Contraception 2007 75:S31-4

1 Trussell J. et al Fertil Control Rev. 1995 4: 8-112 Wu S. et al BJOG 2010 117:1205-10

Anita L. Nelson, MD - 04/19/23 12:16 89CT 2011-09-25 CAPA Palm Springs

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

Anita L. Nelson, MD - 04/19/23 12:16 90CT 2011-09-25 CAPA Palm Springs

DON’T EVER GIVE UP!