Contraception Updates

Amr Nadim, MD
Professor of Obstetrics & Gynecology
Ain Shams Faculty of Medicine
Maternity & Women’s Hospital
Definition
• Contraception (birth control) prevents
pregnancy by interfering with the normal
process of ovulation, fertilization, and
implantation.
• There are different kinds of birth control that
act at different points in the process.
• Unfortunately, there is no perfect form of
birth control.
– Only abstinence can protect against unwanted
pregnancy with 100% reliability.
Contraceptive Options
Hormonal Methods

•Progestin Only Injectables / Oral Contrac

•Combined Injectable / Oral Contraceptive

•Intrauterine Systems
•Vaginal rings
•Implants
•Patches
Contraceptive Options
Non-Hormonal Methods

IUD

NFP methods

Barriers
Contraceptive Options
Sterilization Methods
Tubal Occlusion

Vas Ligation

Tubal ligation
What are the concerns of any couple about
the method of family planning they need?
• When correctly used, all methods are
more effective than no method.

• Safe methods are those without serious

complications.

• Clients should be given their preferred

(or desired) method if it is not medically
contraindicated.
 Risk Misperception & Patients

“…incorrect perceptions of excess

risk of contraceptive products
may lead women to use them less
than effectively or not at all.”

Gardner J, Miller L. J Womens Health. 2005

 Misperceptions Affect Health
Decisions
• 1995 – Warning: possible increased risk of
VTE among users of 3rd generation OCs
• Many women discontinued OC use
• Prescribing patterns changed
• Pregnancy and abortion numbers
increased
• Deemed a “non-epidemic”

Chasen-Taber L. N Engl J Med. 2001.

Drife L. Drug Saf. 2002.
Furedi A. Lancet. 1998.
Spitzer WO. Hum Reprod. 1997.
Definition of Risk

“The possibility of
suffering
harm or loss.”
The American Heritage Dictionary
of the English Language
 Risk Calculations

Weigh Degree to
Causality pros and which
cons attributable

Hennekens CH. Epidemiology in Medicine. 1987.

 Associations vs. Causality
• An association does not always mean exposure
caused outcome
• It could be due to random chance or bias
• Making a decision about causality requires that a
number of criteria be met, including (among others):
– Strength of the association (as measured by relative risk,
for example)
– Consistency of the association over multiple studies
– Temporal sequence (exposure precedes outcome)
• The point is that a weak association found in a
single study should not be taken as concrete
evidence of a cause-and-effect relationship.

Grimes DA. Lancet. 2002.

Commonly Used Risk
Calculations

Absolute
Absolute Relative
risk
risk risk
reduction
 Absolute Risk
• The percentage of people in a group who
experience a discrete event

Number of People With Event

Total # of People At Risk

NY Academy of Medicine. 2005.

Misselbrook D. Fam Practice. 2002.
 Example of Absolute Risk
• Of 100,000 women on 3rd generation OCs,
30 will develop venous thromboembolism
(VTE) per year

Absolute risk

30 per 100,000
woman-years

Mills A. Hum Reprod. 1997.

 Absolute Risk Reduction
• The difference in risk of the outcome
between those exposed and those not
exposed
• Risk in exposed – risk in unexposed
• Reflects the reduction in risk
associated with an intervention

NY Academy of Medicine. 2005.

 Example of Absolute Risk
Reduction
• Of 100,000 women on 2nd generation OCs,
15 will develop VTE per year
Absolute risk
Absolute risk
reduction

15 per 100,000 30 - 15 =
woman-years 15 per 100,000
woman-years

Mills A. Hum Reprod. 1997.

 Attributable Risk
• Similar to absolute risk reduction
• Attributable risk is:
– The difference in risk of the outcome
between those exposed and those not
exposed
– Risk in exposed – rate in unexposed
• Reflects degree of risk associated with
exposure
BMJ Collections. 2006.
 Relative Risk
• Used to identify an association between
exposure and outcome

Exposure Outcome

Grimes DA. Lancet. 2002.

Hennekens CH. Epidemiology in Medicine. 1987.
Odds Ratio
• Used to identify an association between
exposure and outcome in a case-control
study
• Similar to relative risk

Exposure Outcome

Hennekens CH. Epidemiology in Medicine. 1987.

 Relative Risk: Example 1

Absolute risk Absolute risk

3rd Generation OCs 2nd Generation OCs

30 per 100,000 15 per 100,000
woman-years woman-years

Relative risk = 30 / 15 = 2

Mills A. Hum Reprod. 1997.

 Interpreting Relative Risk

Relative risk = 1 Relative risk > 1 Relative risk < 1

No increase in risk
Increased risk in Decreased risk in
in exposed group
exposed group exposed group
compared with
unexposed group

Hennekens CH. Epidemiology in Medicine. 1987.

 Risk & Health Decisions

“Decisions about risk are not technical,

but value decisions.”

Baker B. In: Risk Communication and Public Health. 1999.

 Relative Risk: Example 2

Risk of cesarean delivery with

20%
elective induction of labor
Risk of cesarean delivery with
10%
spontaneous onset of labor
20%
Relative risk with induction:
10%

Relative risk = 20 / 10 = 2
more…
Grimes DA. Lancet. 2002.
 Relative Risk: Example 2
(continued)
• Interpretation:

“The risk of cesarean delivery with

elective induction of labor is 2 times that
associated with spontaneous labor.”

Or, alternatively stated:

“The risk is twice as high.”

more…
Grimes DA. Lancet. 2002.
 Relative Risk: Example 2
(continued)
Graph of relative risk of 2

10
Increased risk
Relative risk
(log scale)

1
Decreased risk

0.1

Grimes DA. Lancet. 2002.

 Relative Risk: Example 3

Rate with prophylactic

6%
antibiotics
Rate without prophylactic
12%
antibiotics:
6% = 0.5
Relative risk:
12%

Relative risk = 6 / 12 = 0.5

more…
Grimes DA. Lancet. 2002.
 Relative Risk: Example 3
(continued)
Graph of relative risk of 0.5

10
Relative risk

Increased risk
(log scale)

Decreased risk
0.1

Grimes DA. Lancet. 2002.

 Comparing Relative Risks of 2
and 0.5
10

2 Zone of
Relative Risk (log scale)

increased risk
1

Zone of
0.5 reduced risk

0.1

Grimes DA. Lancet. 2002.

 Comparative Risks of VTE
60
100,000 woman-years
Incidence of VTE per

40

20

0
Pregnancy High-dose Low-dose General
OC OC Population
Shulman LP. J Reprod Med. 2003.
Chang J. In: Surveillance Summaries. 2003.
Causes of Risk Misperception
about
Hormonal Contraceptives
 Weighing the Risks & Benefits

Burkman R. Am J Obstet Gynecol. 2004.

 Decision Aid for Risk
Communication
Clarify situation

Provide information

Clarify patient’s values

Screen for implementation problems

O’Connor A, Legare F, Stacey D. BMJ. 2003.

A Final Thought

“Two times a very rare event

is still a very rare event.”

David Grimes, MD
2006
 WHO Eligibility Criteria for Contraceptive U

When clinical When clinical

judgment is judgment is Description Category
limited available
Use the method under No restriction for
1
any circumstances use
Use the method
Generally use the Benefits generally
2
method outweigh risks

Use of method not

usually recommended,
Risks generally
unless other methods 3
Do not use the outweigh benefits
are not
method available/acceptable
Unacceptable
Method not to be used 4
health risk

Source: WHO, 2004.

New Methods

Single-rod Implant
Monthly Injecta

LNG IUS

Vaginal Ring Patch

Pill Generations
• High court ruling 2002 –failed to show increase of VTE
odds ratio between 3rd and 2nd generation
• Medicines Committee Advice 1999
– The absolute risk of VTE taking third generation pills is
very small & is much less than the risk in pregnancy.
– There is a small excess risk of 10 cases of VTE per
100,000 women compared with those taking second
generation pill.
• Provided women are fully informed of the small risks & do
not have medical contraindications, it should be a matter
of clinical judgement and personal choice which COC is
prescribed.
 1st, 2nd and 3rd Generation Progestins

• The terms "new', "newer, "second generation" and

"third generation" do not accurately describe OC
progestins.
• Progestins are best classified into
– Gonanes (Levonorgestrel, desogestrel, gestodene and
norgestimate)
– Estranes (Norethindrone, Lynestrenol)
• Estranes and gonanes differ in :
– Bioavailability
• The greater the posthepatic bioavailability , the lower is the dose
needed to be used.
– Only norethindrone, gestodene and levonorgetrel are active as
such. Other progestins are prodrugs and so need to be given in
higher dosages to compensate for hepatic biotransformation.
1st, 2nd and 3rd Generation Progestins
– Serum half-lives
• Long serum half life is associated with more consistent cycle control
and greater contraceptive protection in the event of missed pills.
• The shortest half life is that of norethindrone (7 hours) and the
longest is that of levonorgestrel (15 hours).
– Relative binding affinity to the progesterone receptors.
• Greater relative binding affinity means that a smaller dose is needed
for a consistent clinical effect to be achieved. Among OC progestin,
levonorgestrel has the highest relative binding affinity followed by the
active metabolite of the desogestrel.
• Strong Evidence suggests that all progestins effectively reduce free
testosterone levels by 40-50% in average women.
1st, 2nd and 3rd Generation Progestins
– All OCs inhibit the 5 -reductase in the skin
resulting in lower levels of active
dihydrotestosterone with subsequent better
control of acne and hirsutism.

There is no evidence to support that one class

of progestin is superior to another with
regard to androgen related conditions.
Anti-androgenic Progestogens
Cyproterone Acetate-(in Diane/ Brenda)
• Anti-androgen with
progestogenic qualities
• Binds strongly to androgen
receptors and prevents action
of testosterone
• Major indication is in those with
significant hirsutism or acne
• Takes 3 months for effect on
acne and 6 months for effect on
hirsuitism
• Can accelerate effect by adding
in extra Androcur initially
Anti-androgenic Progestogens
Drosperinone-(in Yasmin)
• Yasmin-Ethinyloestradiol
30 µg and drospirenone
3mg
• Drosperinone related to
Spironolactone
– Has mild diuretic effects-
less fluid retention
– Antiandrogenic effects
• Weight Loss ?- mainly due
to fluid loss-0.5 kg over 12
months
New Oral Contraceptives
• Yasmin
– 30mcg ethinylestradiol +3mg drosperinone
• Cerazette
– 75 mcg desogestrel
• ovulation inhibition
• efficacy same as for COCs
• ?12 hours leeway but current licence 3 hours as other POPs
• safe if migraine with aura or risk of VTE
• trend towards more amenorrhoea and less bleeding with
time
• no effect on lactation
Cerazette
• A 75 mg POP containing desogestrel
• Assumed to inhibit ovulation
Emergency Contraception
• WHO Study in 1996-7
compared the older Yuzpe
method using high dose
Combined Pills (Nordiol 2 X 2)
with high dose progestogen-
only regime(0.75 mgs LNG X2)
• The POP regime was found to
be more effective with less side
effects.
• Yuzpe and the WHO trial both
used divided doses (12 hours),
up to 72 hours after USI
Emergency Contraception -
Effectiveness
LNG YUZPE
Pregnancy rate 1.1% 3.2%

Efficacy rate 85% 76%

(pregs.prevent
-ed vrs pregs.
expected)
Emergency Contraception

• Both methods are

more effective the
earlier they are
commenced after
USI
• Less nausea on
progestogen only
method- 2% vrs
22%
• No need for routine
anti-emetics
Emergency Contraception

• Microlut +25 pills

where cost or
confidentiality an issue

• 2 pill progestogen-only
ECP: Postinor 2
Hot off the Presses!

• Lancet article published December 2002

showed
– POP emergency contraception retained some
effectiveness up to 120 hours (5 days) after
unprotected sex
– A single stat dose of 1.5 mgs seemed to be
slightly more effective than the divided dose
Von Hertzen H et al. Lancet 2002; 360:1803-10
• FPA Health has now changed its Clinical
Protocols on ECP to reflect this study
• TGA recently approved ECP as a
pharmacist-supplied item
Absorption of oral preparations
• hormones are absorbed from the upper small intestine.
• peak plasma levels reached within 2 hours
• vomiting within 2 hours of ingestion reduces the amount
of hormones absorbed, & missed pill instructions should
be followed during the attack and for the next 7 days.
• in the case of combined oral contraception, the pill free
interval should be omitted if less than 7 pills remain in
the packet.
• diarrhoea (unless severe) is unlikely to affect drug
levels; there are no studies showing any
pharmacological basis for failure.
Metabolism in the liver
• Drugs which increase metabolism of EE and
progestogens, during and up to one month after
stopping treatment.
– anticonvulsants (with the exception of sodium
valproate, clobazam, vigabactrin, gabapentin and
lamotrigine),
– griseofulvin,
– barbiturates,
– ritonovir (and possibly other protease inhibitors
amprenavir, indinavir, lopinavir, nelfinavir, and
saquinavir)
Use of COC and liver enzyme
inducing drugs
• COC users need at least 50mcg of EE to
ensure contraceptive action
• efficacy may be further increased by tricycling,
and/or decreasing the pill free interval
• common practice (for which there is no
evidence) to consider the absence of break
through bleeding as a marker of sufficient
contraceptive cover in this situation.
Use of progestogens and liver
enzyme inducing drugs
• POP users should switch to injectables or another form
of contraception
• IUS no evidence of interaction
– most of its progestogenic effect is directly on the
endometrium with little absorption
• EHC experts suggest that the dose is increased by 50%
– levonorgestrel 0.75 mg 2 + 1 tablets or 3 tablets stat
• injectable progestogen methods are often given 2
weeks early
– data sheet for Depo-Provera states that no adjustment
is needed
Powerful enzyme inducing
drugs
• Rifampicin and rifabutin are such powerful enzyme
inducers that even short courses of 2 days of the former
– (used as prophylaxis in close contacts of cases of
Neisseria meningitis) reduce contraceptive efficacy
for a month.
• Longer courses may have an interactive effect for up to
2 months after stopping.
• Oral contraceptive methods should not be relied on
during this time.
• The same principles should apply to injectables,
implants and IUS
Broad spectrum antibiotics
• EE is excreted into the bile; and reabsorbed into the
circulation from the colon
• broad-spectrum antibiotics (mainly ampicillin and
tetracycline)affect these bacteria
• accepted UK practice that COC used alone is unreliable
while taking short courses of penicillins and tetracyclines
and for 7 days after stopping; the pill free interval should
be omitted if less than 7 pills remain in the pack
– when the drug is continued beyond 2 weeks, the gut flora appear
to become resistant, allowing a return to reabsorption of EE.
• effectiveness of the POP, progestogen-only emergency
contraception, injectables, implants and IUS are not
affected by broad spectrum antibiotics.
The only drugs known to have a clinically
significant impact on contraceptive efficacy
• rifampicin and rifamycin,
• griseofulvin,
• some anticonvulsants
– topiramate,
– barbiturates,
– carbamazepine,
– primidone
• ritonovir,
• and in some women short courses of tetracyclines
and ampicillin.
 Why Another Contraceptive
Method?

CHOICE

Varney SJ. Pharmacoeconomics. 2004

Why Implantable
Contraception?
• Long duration of action
• Not patient dependent
• Continuous steady state steroid levels
• Avoidance of first-pass effect from GI
absorption and hepatic metabolism
• High bioavailability
 Why is it among the most
effective?

“Implants constitute one of the

safest and most effective forms
of contraception that exist.”

WHO, 2003

World Health Organization. 2003

Unmet Need for Contraceptive
Method

Highly No daily Rapidly

Safe
effective motivation reversible
Implant Systems
6-Rod 2-Rod 1-Rod
Norplant Jadelle Implanon
 Contraceptive Implant Track
Record
1993
1966 1985 Norplant
Implant R&D  WHO acceptance launch UK

1968 1990
Ongoing Norplant
clinical launch US
trails
more…
Population Council. www.popcouncil.org
Organon Data on File
 Contraceptive Implant Track
Record (continued)
1998 2002
Implanon enters Norplant removed
international market from US

2002 2006
Jadelle approved but FDA
not marketed in US approves
Implanon
Population Council. www.popcouncil.org
Organon Data on File
Subdermal Implant

• Single-rod system with disposable

inserter
• Releases etonogestrel
(3-ketodesogestrel) for three years
• As of July 2002 not approved by the
FDA
 Features of Contraceptive
Implants
• Highly effective
• Not motivation dependent
• Can be used during
lactation
• Discreet, virtually invisible
• Rapidly reversible

more…
Reinprayoon D, et al. Contraception. 2000.
Diaz S. Contraception. 2000.
 Features of Contraceptive
Implants (continued)
• Stable hormone levels
• Extended protection
• Contain no estrogen
• Safe

Reinprayoon D, et al. Contraception. 2000.

Diaz S. Contraception. 2000.
Limitations of Contraceptive
Implants
• Can cause irregular
bleeding
• Requires clinician visits
for insertion and removal
• Does not protect from
STDs
Single-Rod Implant
One rod 4 cm x 2 mm
• Core
• 40% ethylene vinyl acetate
(EVA)
• 60% etonogestrel (68 mg)
• Rate-controlling
membrane
• 100% EVA
 Pharmacology
Progestin-only Class
Subdermal Route
Implantable rod; 68 mg
Formulation
etonogestrel
~100% Bioavailability
Hepatic via CYP3A4 Metabolism
~ 25 h Half-life
Primary urine; some fecal Excretion
ANON. Obstet Gynecol. 2007
 Mechanism of Action
• Suppresses ovulation
• Increases cervical mucus viscosity
• Alters endometrium

IMPLANONTM Physician insert, 2006

 Components of the Single-Rod
Implant Insertion System

Funk S. Contraception. 2005

Preparation Tips
• Supine position
• Nondominant arm, flexed
and externally rotated
• Subdermal groove
• Hold applicator up
(vertical) before insertion
Insertion Steps Overview
Mark site and sterilize

Inject local anesthetic just under skin

Remove applicator, maintain sterility

Verify implant is within needle of applicator

Remove needle cover more…

Insertion Steps Overview
(continued)

Stretch skin at insertion site (a)

Lift or tent skin with needle tip

while inserting and insert
needle to full length (b)

Press the obturator support

to break seal of applicator more…
Insertion Steps Overview
(continued)
Turn obturator 90 degrees
and fix with one hand (c)

With other hand, pull

needle out (d)

Palpate to verify correct insertion

Removal Tips
• Inject local anesthetic
under rod
• Incision over distal end
• Use sharp or blunt
dissection if encapsulated
• Insert new implant
through same incision or
opposite arm
Removal Steps Overview
Locate rod and mark site (a)

Sterilize site

Inject local anesthetic under

distal end of rod (b)

Press down on proximal end of

rod more…
Removal Steps Overview
(continued)

Use scalpel to make 2–3 mm

incision over distal end (c)

Gently push rod toward incision, then

grasp with mosquito forceps (d)

Close with steri-strip closure

 Trouble Shooting: Removals
• Unrecognized non-insertion
• Deep placement
• Significant weight gain
• Migration

James P. Aust N Z J Obstet Gynecol. 2006.

Piessens SG. Aust N Z J Obstet Gynecol. 2005.
Vaginal Ring
• Steroid release
– Progestin: Etonogestrel: 120 mcg/day
(~1500 pg/ml)
– Estrogen: Ethinyl estradiol: 15 mcg/day
(~20 pg/ml)
• Worn for three weeks out of four
• Approved by the FDA in October 2001
Vaginal Ring: Characteristics

• Self administered
• Insertion every four weeks
• Foreign body in vagina
• Expulsions
• Limited published data on efficacy
Vaginal Ring: Efficacy

16 Number of women

16 cycles Woman-cycles of use

Limited Cumulative pregnancy

published rate
data
Timmer and Mulders. Clin Pharmacokinet 2000;39
Contraceptive Patch

• Steroid release
– Progestin: norelgestromin 150 mcg/day
– Estrogen: ethinyl estradiol 20 mcg/day
• Worn for three weeks out of four
• Approved by the FDA in November 2001
Contraceptive Patch:
Characteristics
• Self administered
• Once-a-week administration
• Hormonal side effects
• Efficacy similar to combined oral
contraceptives

Audet et al. Jama 2001;258:23

Patch: Efficacy

1,417 Number of women

2,440 Woman-cycles of use

1% Cumulative pregnancy rate

Shangold et al. Obstet Gynecol 2000;95:S36

 History of Intrauterine
Contraception
1909: 1967:
Grafenberg develops "T" shaped device
ring-shaped IUD device developed

1962:
1st international conference on
IUDs; designs for plastic spiral
and plastic loop presented

more…

Richter R. Deutsche Med Wochenschr. 1909.; Grafenberg E. 1929.; Ishihama A.

Yokohama Med Bull. 1959.; Oppenheimer W. Am J Obstet Gynecol. 1959.; Berelson B.
1964; Marguiles LC. 1962.; Lippes J. 1962.; Hubacher D, Cheng D. Contraception. 2004.
History of Intrauterine
Contraception (continued)
1968: 1980:
Contraceptive action of LNG IUD tested in
intrauterine copper reported randomized clinical trials

1976:
Copper T 200 becomes
first copper IUD

Lee NC. Obstet Gynecol. 1983.

History of Intrauterine
Contraception (continued)
1988: Today:
Copper T 380 IUD Only 2% of US
available in the U.S. women use IUDs

2001:
LNG IUD available
in the U.S.

Mosher WD, et al. 2004.

 Comparison of Copper IUDs

Recommended 1st Year Failure

Lifespan per 100 women
12 years 0.3 TCu 380A

3 years 1.2 Multiload Cu 250

5 years 1.4 Multiload Cu 375

3 years 2.3 TCu 200

5 years 3.3 Nova T

Source: FHI clinical trials, 1985-1989.

Dispelling Common Myths
About IUDs
• In fact, IUDs:
– Are not abortifacients
– Do not cause ectopic pregnancies
– Do not cause pelvic infection
– Do not decrease the likelihood of future
pregnancies
– Are not large in size

more…

Hubacher D, et al. N Engl J Med. 2001.; Stanwood NL, et al. Obstet Gynecol. 2002.
Forrest JD. Obstet Gynecol Surv. 1996.; Lippes J. Am J Obstet Gynecol. 1999.
Dispelling Common Myths
About IUDs (continued)
• In fact, IUDs:
– Can be used by nulliparous women
– Can be used by women who have had an
ectopic pregnancy
– Do not need to be removed for PID treatment
– Do not have to be removed if actinomyces-
like organisms (ALO) are noted on a Pap test

Duenas JL. Contraception. 1996.; Stanwood NL. Obstet Gynecol. 2002. Forrest JD.
Obstet Gynecol Surv. 1996; Lippes J. Am J Obstet Gynecol. 1999. Otero-Flores JB.
Contraception. 2003.; WHO. 2004.; Penney G. J Fam Plann Reprod Health Care. 2004.
Safety: IUDs Do Not Cause PID
• PID incidence for IUD users is similar to
that of the general population
• Risk is increased only during the first
month after insertion
• Preexisting STI at time of insertion, not
the IUD itself, increases risk

Svensson L, et al. JAMA. 1984.

Sivin I, et al. Contraception. 1991.
Farley T, et al. Lancet. 1992.
Rate of PID by Duration of IUD
Use
Rate per 1,000 woman years
N = 20,000 women

9.25

1.6
<21 days of use 21 days - 8 years of use

Adapted from Farley T, et al. Lancet. 1992.

Risk of Fetal Abnormality
• IUD is extra-amniotic
• No increase in birth
defects for copper IUD

Atrash HK, et al. 1994.

Layde PM, et al. Fertil Steril. 1979.
Simpson JL. Res Front Fertil Regul. 1985.
Safety: IUD Does Not Cause
Infertility
• IUD is not related to infertility
• Chlamydia is related to infertility
10

Tubal infertility by previous

Odds Ratio

copper T IUD use and

1 presence of chlamydia
antibodies, nulligravid women

0,1

Hubacher D, et al. NEJM. 2001.

Fertility Rates in Parous Women
After Discontinuation of
Contraceptive
100

80
Pregnancies (%)

60 IUC
OC
40 Diaphragm
Other methods
20

0
0 12 18 24 30 36 42
Months After Discontinuation
Vessey MP, et al. Br Med J. 1983.
Andersson K, et al. Contraception. 1992.
Belhadj H, et al. Contraception. 1986.
Safety: IUDs May Be
Used by HIV- Positive
Women
• No increased risk of
complications
compared with HIV-
negative women
• No increased cervical
viral shedding
• WHO Category 2
rating
WHO. Medical Eligibility Criteria for Contraceptive Use. 2004.
Morrison CS, et al. Brit J Obstet Gynaecol. 2001.
Richardson B, et al. AIDS. 1999.
Safety: LNG IUD Does Not
Increase Breast Cancer Risk
Average Finnish
population: LNG users:
Incidence rate per Incidence rate
100,000 woman- per 100,000 Age Group
years woman-years (y)
25.5 27.2 30–34
49.2 74.0 35–39
122.4 120.3 40–44
232.5 203.6 45–49
Backman T, et al. Obstet Gynecol. 2005.
272.6 258.5 50–54
Safety: IUDs May Be Used in
Nulligravid Women
• No evidence of increased
infertility
• Risk of PID and
subsequent infertility
dependent on non-IUD
factors

WHO. 2004.; Hubacher D, et al. NEJM. 2001.; Delbarge W, et al. Eur J Contracept
Reprod Health Care. 2002.; Hov GG, et al. Contraception. 2007.
Penney G, et al. J Fam Plann Reprod Health Care. 2004.
Screening: Appropriate
Candidates for Intrauterine
Contraception (continued)
Copper T IUD LNG IUD

Women who don’t Women who request

want hormonal less menstrual flow
contraception or want and/or who
contraception for experience
more than 5 years dysmenorrhea or
dysfunctional uterine
bleeding
Screening: Poor Candidates for
Intrauterine Contraception
• Known or suspected pregnancy
• Puerperal sepsis
• Immediate post septic abortion
• Unexplained vaginal bleeding
• Cervical or endometrial cancer

more…

WHO. Medical Eligibility Criteria for Contraceptive Use. 2004.

Screening: Poor Candidates for
Intrauterine Contraception
(continued)
• Uterine fibroids that interfere with
placement
• Uterine distortion (congenital or acquired)
• Current PID
• Current purulent cervicitis, chlamydia, or
gonorrhea
• Known pelvic tuberculosis

WHO. Medical Eligibility Criteria for Contraceptive Use. 2004.

IUD Insertion After
Spontaneous or Induced
Abortion
• May be safely inserted immediately after
spontaneous or induced abortions
• Not recommended after septic abortion

Grimes D, et al. Cochrane Library. 2000.

ParaGard label. 2006.
WHO. 1983.
IUD for Postpartum Use
May be safely inserted in postpartum women
Copper T IUD LNG IUD

Within 48 hours 6 weeks postpartum

postpartum

OR

After 4 weeks once

uterus is involuted
Treiman K, et al. Population Reports. 1995; Mishell DR, et al. Am J Obstet Gynecol. 1982;
Kennedy KI, et al. In Hatcher RA, et al. Contraceptive Technology. 18th revised ed. 2004.
IUD Use During Lactation
• Effectiveness not decreased
• Uterine perforation risk unchanged
• Expulsion rates unchanged
• Decreased insertional pain
• Reduced rate of removal for bleeding and
pain
• LNG comparable to copper T in
breastfeeding parameters
Chi I-C, et al. Contraception. 1989;
Mirena label. 2006.
Shaamash AH, et al. Contraception. 2005.
Checklist for STI Risk
Assessment
No Yes Circle appropriate answer

0 1 Is the client < 25 years old?

Is she currently living apart from

0 1
her husband or partner?
During the last year, has she had
bleeding between periods or
0 1
bleeding or spotting within 24
hours after sex?
more…
Is her school education <
0 1
Morrison CS, et al. Contraception. 2007.
secondary level?
Checklist for STI Risk
Assessment (continued)
None How many different sexual
>
One partners has she had during
One 0 the last 3 months?
If she has had one or more
partners, how often has she
used a condom in the last 3
months?
1 0 Never used condoms
1 1 Sometimes used condoms
Morrison CS, et al. Contraception. 2007.
0 0 Always used condoms
Scoring STI Risk Assessment
High cervical Low cervical
infection infection Recommended
population population action
(=10%) (<10%)

If score is Counsel/refer for IUD

If score is 0 insertion without any
0–2 reservations
Consider
presumptive
treatment for
If score is 1+ If score is 3+ chlamydia/ gonorrhea
Morrison CS, et al. Contraception. 2006.
(if available) or
Levonorgestrel Intrauterine
System (LNG IUS)
32 mm

Steroid reservoir
levonorgestrel 20
mcg/day

Approved December
LNG IUS: Characteristics
• High efficacy
• Long-term reversible method
• Reduction in menstrual blood loss
• Low systemic levels of LNG
• Early spotting common
• Foreign body in the uterus
• Expulsions
• Requires professional insertion
LNG IUS: Mechanism of Action

• Fertilization inhibition:
– Cervical mucus thickened
– Sperm motility and function
inhibited
– Endometrium suppressed
– Weak foreign body reaction
induced
– Ovulation inhibited (in some
cycles)
Jonsson et al. Contraception 1991;43:447
Videla-Rivero et al. Contraception 1987;36:217
LNG IUS: Efficacy
• Overall failure rate 0.14 per 100
woman-years

• Gross cumulative five-year rate is

0.71 per 100 women

Andersson et al. Contraception 1994;49:56

Luukkainen et al. Contraception 1987;36:169
LNG IUS: Efficacy
Five -Ye a r Cumula tive Pre g na nc y
Ra te s pe r 1 0 0 Wo me n by Ag e a nd
IUD Type
2,9
3 LNG IUS
2,5 Nova T
2
1,5
1,5
1 0,8
0,6
0,5 0 ,1 0 ,1 0 ,2
0
0
<=25 26 - 30 31 - 35 36+
Age (Years)

Luukkainen and Toivonen. Contraception 1995;52:269

LNG IUS: Comparison to
Sterilization
5 -ye a r g ro s s c umula tive fa ilure ra te pe r 1 0 0
w o me n
LNG IUS
2
Nova T

1,4 All Sterilization

1,3
Post Partum
Salpingectomy
1
0,6
0,5

Andersson et al. Contraception 1994;49:56

Peterson et al. Am J Obstet Gynecol 1996;174:1161
LNG IUS: Return to Fertility
LNG IUS
100
Cumulative pregnancy rate (%)

80
Copper IUD

60

40

20

0
3 6 9 12
Months
Andersson et al. Contraception 1992;46:575
Belhadj et al. Contraception 1986;34:261
Plasma Concentrations of
Levonorgestrel
7000
Plasma concentrations (pg/mL)

6000

5000

4000

3000

2000

1000

0
LNG IUS Implant Mini-pill Combined OCs

Nilsson et al. Acta Endocrinol 1980;93:380

Diaz et al. Contraception 1987;35:551
 LNG IUS: Endometrial Effect

Months

Ovulation

ys of cycle

Changes in the endometrium during normal m

 LNG IUS: Endometrial Effect

Months

Ovulation

ys of cycle
Endometrium in “resting state” with
Pakarinen et al. Fertil Steril 199
LNG IUS: Early Spotting
• Endometrial suppression effect is not
immediate
• Takes three months for full effect on
the endometrium
• Spotting is common during this time

Silverberg et al. Int J Gynecol Pathol 1

LNG IUS: Number of Bleeding
Days
Days
6
Copper IUD
4

2
LNG IUS
0
0 4 8 12 16 20 24
Months
Luukkainen and Toivonen. 1992;90
LNG IUS: Bleeding Patterns
• 20 % of women will
have no bleeding
at all after 12
months

Pekonen et al. J Clin Endocrinol Metab 1992;75:660

Luukkainen et al. Contraception 1987;36:169
LNG IUS: Non-contraceptive
Therapeutic Uses
• Alternative to hysterectomy
– Cancelled hysterectomy: 80 % LNG IUS
vs. 9 % normal care
• Treatment of menorraghia
– 97 % decrease in menstrual blood loss
(MBL)

Hurskainen et al. Lancet. 2001 Jan 27;357:273

Andersson and Rybo. Br J Obstet Gynaecol. 1990 Aug;97:690
LNG IUS: Non-contraceptive
Therapeutic Uses (cont)
• Hormone replacement therapy (HRT)
– Days of bleeding/spotting at 12 months:
2 LNG IUS vs. 6 oral LNG
• Adjuvant therapy for tamoxifen users
– Decidual change in endometrium of all
women with LNG IUS

Barrington and Bowen-Simpkins. Br J Obstet Gynaecol. 1997

May;104:614
Gardner et al. Lancet. 2000 Nov 18;356:1711
US Preventive Services Task
Force Ratings
Strength of
conclusion LNG IUS Finding
Increases concentration of
A
hemoglobin

Effective treatment for

A
menorraghia
Well-accepted alternative to
B
hysterectomy
Hubacher and Grimes. Obstet Gynecol Surv 2002 Feb;57:120
US Preventive Services Task
Force Ratings (cont)
Strength of
conclusion LNG IUS Finding
A Prevents anemia
Can be used as a vehicle for
A hormone replacement therapy
(HRT)
Mitigates tamoxifen-induced
B
endometrial effects

Hubacher and Grimes. Obstet Gynecol Surv 2002 Feb;57:120

LNG IUS: Possible
Complications
Consider Symptoms
Expulsion Return of menstruation

Infection Fever/chills

Continuous bleeding
Perforation, infection,
and/or pain after first
or partial expulsion
month post-insertion
LNG IUS: Possible Complications
(cont)

Consider Symptoms
Dislocation or Irregular bleeding and/or
perforation pain in every cycle

Dislocation or
Missing string
perforation
LNG IUS: Potential
Contraindications
• Pregnancy or suspicion of pregnancy
• Active cervical or endometrial
infections
• Uterine anomaly
• Complete list included in the package
labeling
LNG IUS: Potential
Complications
• Expulsions
– Most occur during the first six months after
insertion
– The five-year cumulative expulsion rate is 4.9
per 100 women
• Perforations
– Occur at the time of insertion
– Rare events, fewer than one per thousand

Andersson et al. Contraception 1994

LNG IUS: The Inserter
LNG IUS: Insertion

• Different insertion technique than

other intrauterine contraception
– New, one-handed insertion
– Requires hands-on training
• Efficacy and user continuation
dependent on skillful insertion
LNG IUS: Counseling
• Efficacy
• Return to fertility
• Side effects
• Changes in bleeding patterns
• Non-contraceptive health benefits
• Safety
• Insertion and follow-up
LNG IUS Counseling: Efficacy

• High efficacy
– In clinical studies failure rate about
that of female and male
sterilization
• Continuous contraception for up to
five years
LNG IUS Counseling: Side
Effects
• Possible hormonal side effects
– Mood changes
– Acne
– Headache
– Breast tenderness
– Nausea
• No reported weight gain
Mean Weight Change After Five
Years
3
2,5
2,5 2,4
Weight gain in kg

1,5

0,5

0
Nova T LNG IUS
Andersson et al. Contraception 199
LNG IUS Counseling: Changes
in Bleeding
• Bleeding characteristics:
• 1 – 4 mo frequent spotting
• 1 – 6 mo reduced duration and amount
of bleeding
• Reduction in menstrual blood loss
• After 12 mo, about 20 % have no
bleeding
Pakarinen et al. Fertil Steril 1997;68:
LNG IUS Counseling: Absence
of Bleeding
• Local effect
– No proliferation of endometrium
• This is expected. It is not a sign of:
– Pregnancy
– Ovarian or pituitary dysfunction
– Menopause
• Rapid return to menstruation after
removal
LNG IUS Counseling: Health
Benefits
• Reduction of
– Duration and amount of bleeding
– Ectopic pregnancies
– Menstrual pain
• Increase of
– Hemoglobin
– Iron storage
Luukkainen et al. Contraception 1987;
LNG IUS Counseling: Safety
• > Ten years experience in Europe
• > Two million users world wide
• Few serious side effects
• Highly effective
• Does not prevent acquisition of STDs
– Condoms advised for women at risk
LNG IUS Counseling: Insertion

• Steps in the insertion process

– Pelvic and speculum exam
– Sensations produced by tenaculum
– Paracervical anesthesia, if needed
– Sensations of IUS as it is inserted
– Measures you will take for her
comfort
LNG IUS Counseling: Post-
Insertion
• Schedule a follow-up visit at 1 – 3
months post-insertion
– Check for partial or complete
expulsion
– Address any questions or concerns
LNG IUS: Therapeutic
Possibilities
• Range of non-contraceptive benefits,
including:
– Treatment of heavy menstrual
bleeding
– Endometrial protection for women
receiving estrogen replacement
therapy
LNG IUS: Treatment of Heavy
Bleeding
400
Menstrual blood loss (ml)

300

200

100

0
3 6 12
Before
treatment Months of use
Andersson and Rybo. Br J Obstet Gynaecol 1990;97:690
LNG IUS: Percentage Reduction of
Menstrual Blood Loss
0

LNG IUS
-25
Placebo

-50 Prostaglandin
Synthetase Inhibitor
Combination OCs
-75

-100
Milsom et al. Am J Obstet Gynecol 1991
LNG IUS vs. Endometrial
Resection
500
Levonorgestrel
assessment chart score

400 intrauterine
Pictorial blood loss

system
300 Endometrial
resection
200

100

0
Baseline 6 months 12
months
Crosignani et al. Obstet Gynecol 1997;90
LNG IUS as Alternative to
Hysterectomy
70
Women Canceling
60
Hysterectomy
50
Percent

40
30
20
10
0
LNG IUS Medical Therapies

Lahteenmaki et al. BMJ 1998;316:1122

LNG IUS: Hormone
Replacement
• Prevention of endometrial hyperplasia
from estrogen therapy
• “Local is logical”
• Oral progestins can cause depression
• LNG IUS avoids systemic side effects of
oral progestins

Girdler et al. J Womens Health Gend Based Med 1999;8:637

LNG IUS: Hormone
Replacement
• Bleeding is the most common
reason why women discontinue HRT
• LNG IUS suppresses endometrium
• 83 – 88 % have no bleeding/
spotting at 12 months
• 82 % continuation rate at three years
Ettinger. Menopause 1999;6:273
Suhonen et al. Acta Obstet Gynecol Scand 1997;76:145
General Discussion
• New methods are coming to U.S. market
• This should translate into more
contraceptive choices, fewer unintended
pregnancies
• These new methods share the common
advantage of not requiring daily attention
Intrauterine Contraception in the
U.S.
Copper IUD LNG IUS
20 mcg
copper ions
levonorgestrel/day
Approved for Approved for
10 years 5 years

Approved 1988 Approved 2000

 PID Incidence Rate for All IUDs
by Time Since Insertion
Combined WHO clinical trial data for all IUDs - 22,908 IUD insertions
8 (per 1,000 woman-years)

0
1 2 3 4 5 6 7 8 9 10 11 12 2 3 4 5 6 7 8

Month (first year) Year

Time Since Insertion

Farley et al. Lancet 1992;339
Dispelling Myths:
Intrauterine Contraception
• Infections are a frequent problem
• Prevents implantation
• Women are not interested in
intrauterine contraception
Prophylactic Antibiotics?

• Any risk of infection associated with

the IUD relates to insertion
• One woman in 1,000 will develop PID
in the first three months
• Meta-analysis has not shown any
overall benefit of prophylactic
antibiotics
Grimes and Schulz. Contraception 19
Walsh et al. Lancet 1998;351:1005
Myth: IUD Prevents
Implantation
• Most evidence now suggests that all
IUDs induce a foreign body reaction
that is spermicidal, preventing
fertilization
• Today’s intrauterine contraceptives
have other mechanisms of action that
prevent fertilization

Alvarez et al. Fertil Steril 1988;49:768

Use of Contraception by U.S.
Women Physicians
Women MDs General Population
% of Women Using Method

40

20

0
Sterilization IUD Pills

Frank. Obstet Gynecol 1999;94

Incidence* of Ectopic
Pregnancy
0.20 LNG IUS
0.34 Copper IUD
1.20-1.60 No method
2.00 All U.S. women

* Per 1,000 woman-years

Andersson et al. Contraception 1994;49:56
Sivin. Stud Fam Plann 1983;14:57
Summary
• LNG IUS bleeding patterns:
– 1 – 4 mo frequent spotting
– 1 – 6 mo reduced duration and amount of
bleeding
– > 12 mo, about 20 % have no bleeding
• Treatment of heavy menstrual bleeding
and endometrial protection with HRT
Gynefix- Frameless IUD
• Developed 1994 in Belgium-
available in Europe and UK
• Frameless IUD-copper tubes
on a thread with a knot to
anchor to the fundus
• Reduced risk of expulsion,
pain & heavy bleeding
• Progestogen device in
development
Female Barrier Contraception-
Diaphragms and Caps
• Rubber barriers placed into the vagina
to cover the cervix prior to sex
• Sperm remain in vagina where acid
conditions kill the sperm in a few hours-
need to remain inside for 6 hours.
• Use of spermicide is controversial
• Failure rates anything from 5-20%-rates
lower in older women and experienced
users
• Need to be individually fitted
• Last approximately 2 years
• Size needs to be checked if weight gain,
failure, or pregnancy
• Affected by oil based vaginal lubricants
and treatments eg Antifungal creams
and pessaries
Barriers-The Female Condom

• Lubricated, loose
fitting polyurethane
sheath with 2
flexible rings - one
size fits all
• Lines the vagina
and covers some of
the vulva
• Effectiveness: 85-
95%
The Female Condom
• Advantages
– Contraception and STI protection
– Can be used with oil based products
– Better heat transmission
– Stronger than latex
– Less “constriction” for partner
– Does not need erection before use
– May provide better protection against herpes
and HPV
• Disadvantages
– Harder to dispose of than male condom
– Requires careful insertion and practise
– Not yet widely available
Latex male condoms

• Cornerstone of safer sex-

must be used every time
to provide maximal
protection
• Can be used with other
methods of contraception-
“Double Dutch”
• Affected by oil based
lubricants and vaginal
medications like
antifungals
Polyurethane Male Condom
• Stronger and thinner than
latex condoms
• Better heat transmission
• Can safely be used with
oil-based lubricants
• Can be used by those
with latex allergies
Permanent Contraception-
• Inner wire/outer coil with
synthetic fibre between
• Inserted into uterine ends of
Fallopian tubes through
hysteroscope under LA
• Growth of fibroblasts causes
scarring and permanent closure
of the tubes -irreversible
Sterilization: Tubal Ligation
Methods
Methods for accessing the fallopian
tubes
• Laparotomy
• Mini-laparotomy
• Vaginal posterior colpotomy
• Laparoscopy
• Hysteroscopy
Tubal Sterilization:
FDA-Approved Methods
The most widely used occlusion methods are
typically performed on the isthmic portion of the
fallopian tube:
• Partial salpingectomy
• Clips
• Silicone rings
• Electrocoagulation
• Micro-insert
Hysteroscopic Sterilization
Techniques
Electrocoagulation

Uterotubal Junction
Intra-tubal Device
Device
Hamou, 1982
Hossenian, 1976
Hysteroscopic Sterilization
Techniques (continued)
Chemical

P-Block Device OvaPlug

Brundin, 1981 1981
Transcervical Sterilization
Methods

Continuous Advanced
Endoscope
Flow Cardiology
Efficiency
Technology Technology
Transcervical Sterilization:
Advantages to the Provider
• Outpatient procedure
• No general or regional
anesthesia
• Women with certain medical
conditions may be eligible
Transcervical Sterilization:
Disadvantages to the Provider
• Special equipment and training
needed for insertion
• Some women may not be
candidates
• Uncertainty still exists about long-
term effectiveness and insurance
coverage
Transcervical Sterilization:
Advantages to the Patient
• No incision
• Absence of a scar preserves privacy
• Less invasive
• Less discomfort
• Faster recovery
• Efficacy
Transcervical Sterilization:
Disadvantages to the Patient
• Another contraceptive method is
required for three months after
insertion
• Non-reversible; some women
may experience regret
 New Tubal Occlusion Method:
Micro-Insert Tubal Occlusion
(Essure®)
• FDA approval in November 2002
• Only FDA approved hysteroscopic
method of tubal sterilization available
• Placement of micro-
inserts into proximal
fallopian tubes
 Micro-Insert: Design
Fiber Material: PET

Dynamic Expanding
Superelastic Outer Inner Coil Material:
Coil Material: Nitinol Stainless Steel

Micro-Insert length = 4
cm
ARHP. Clinical Proceedings. May 2002.
 Micro-Insert: Mechanism of
Action
• Expansion of outer coil for acute anchoring
• Space filling/mechanical blockage of tubal
lumen
• Tubal occlusion by tissue in-growth into
and around the micro-insert
• Long-term nature of tissue response not
known beyond 24 months

Essure® Prescribing Information

Male Hormonal Contraception
• Recent trials at Andrology Clinic,
Concord Hospital
• Depo Provera plus testosterone
implants 3 monthly
• Very low sperm count (less than
1 million per ml) in all men on trial
- 80% had no sperm
• Few side-effects
• Similar regime using an oral
progestogen and testosterone
implants being trialed in UK
• Implants and testosterone also
being trialed
The Introduction of a New
Contraceptive Method to the Market
• New contraceptive methods
usually considered newsworthy
• Consumers increasingly well
informed around options and
their rights to informed choice
• The growing number of options
available makes it increasingly
difficult for health practitioners
to do justice to the pros and
cons of each method in the
available time.
 Contraceptive Counselling
• The trend to an increase in available contraceptive
options seems likely to continue along with an
acceptance that the consumer has a right to accurate,
comprehensive and balanced information from their
health provider
• Any clinician attempting to counsel a patient around
contraceptive choice will need to put this counselling
within the broader context of the person’s past
experiences, cultural background and belief systems
• A person will rarely persist with a contraceptive method
they do not feel is right for them - they will simply feel
their practitioner has not heard them
• In the area of contraception the clinician is often the
adviser, sometimes the supplier, but, if they have any
sense at all, never the decider.