Contraception in the Community Adapted by Jill Gallin, CPNP

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Contraception in the Community
Adapted by Jill Gallin, CPNP
Assistant Professor of Clinical Nursing
U.S. Pregnancies:
Unintended vs. Intended
Intended
51%
Unintended
49%:
Unintended births
(22.5%)
Elective abortions
(26.5%)
Henshaw SK. Fam Plann Perspect. 1998;30:24-29.
www.contraceptiononline.org
Adolescents Who Have Had Intercourse
100
1970
90
1975
1980
1985
1988
1995
80
Percent
70
60
50
40
30
20
10
0
15
16
17
18
19
All
Age (y)
National Surveys of Family Growth. 1970, 1975, 1980, 1985, 1988, and 1995.
www.contraceptiononline.org
The Need for Contraception
Unintended Pregnancies (%) by Age
100
Percent
80
60
40
20
0
15-19
20-24
25-29
30-34
Age (y)
35-39
40+
Henshaw SK. Fam Plann Perspect. 1998;30:24-29, 46.
www.contraceptiononline.org
The Need for Contraception
Pregnancies Ending in Abortion by Age
50
40
30
20
10
0
15-19
20-24
25-29
30-34
35-39
40+
Age (y)
*Does not include miscarriages.
Henshaw SK. Fam Plann Perspect. 1998;30:24-29, 46.
www.contraceptiononline.org
Adolescent Pregnancy
Pregnancies/1,000 19 y*
An International Perspective—Developed
Countries
100
80
Abortions
44
60
22
40
20
0
Births
26
15
53
49
44
32
19
27
13
32
16
24
22
18
24
11
15
16
12
9
4
6
6
4
*1988.
Reproduced with permission from The Alan Guttmacher Institute. Sex and America’s
Teenagers, 1994.
www.contraceptiononline.org
Adolescents Delay Seeking Medical
Contraceptive Services
Made no visit
31%
Before/same month
12%
1 y or more after
29%
7-12 months after
12%
4-6 months after
1-3 months after 5%
11%
Alan Guttmacher Institute. Sex and America's Teenagers,1994
www.contraceptiononline.org
FDA Advisory Committee’s
Recommendation on Delay of Pelvic
Exam
“Physical
examination may be
deferred until after
initiation of oral
contraceptives if
requested by the
woman and judged
appropriate by the
clinician.”
FDA Advisory Committee Recommendation.
www.contraceptiononline.org
Adolescents’ Contraception at First
Intercourse
Other 1%
OCs 8%
No method
35%
Withdrawl
13%
Withdrawl 4%
Condom
61%
Other 1%
Condom
48%
Withdrawl 8%
No method
52%
1995
OCs 8%
Other 4%
No method
23%
OCs 11%
Condom
23%
1988
1982
National Surveys of Family Growth, 1992, 1988, and 1995.
www.contraceptiononline.org
Method Use, Last Intercourse
Young Women, 14 to 22 years old
60
14-15
16
17
18
19
20
21-22
ALL
50
40
30
20
10
0
nly
o
l
l
Pi
do
n
o
C
nly
o
m
om
om
om
d
d
d
n
n
n
co
co
/co
l
d
d
a
n
n
a
a
aw
r
r
e
d
Pill
h
h
Ot
Wit
Santelli JS et al. Fam Plann Perspect. 1997;29:261-267.
N on
e
www.contraceptiononline.org
Properties of Contraceptives
Desired by Women
 Highly effective
 Prolonged duration of action
 Rapidly reversible
 Privacy of use
 Protection against STD
 Easily accessible
www.contraceptiononline.org
Optimizing Patient Choices
 Effectiveness
 Theoretical
 Actual
 Cost and ability to pay
 Side effects
 Importance of not being
 Perceptions, misperceptions,
 Likelihood and ability to
 Concomitant drug use
pregnant
comply
 Frequency of intercourse
risk/benefit
 Health status and habits
 Age
www.contraceptiononline.org
Common Contraceptive Choices
 Oral contraceptives: combined, progestin-only
 Long-acting
 Injectable
 Implant
 IUD: copper T, progestin-only
 Barrier contraceptives
 Spermicides
 Natural family planning
 Emergency contraceptives
 Female/male sterilization
www.contraceptiononline.org
Current Trends in Contraception
 Developing new delivery systems
 Increasing access to a full range of options
 Emphasizing better compliance
 Widening use of emergency contraception
www.contraceptiononline.org
Oral Contraceptives
 Dosing: every day same time
 Rx refill
 Cost
 Not so private
 Side Effects
 Contraindications
 See handout
 Combined
 Progesterone only
Plasma Drug Level (ng/mL)
Levonorgestrel and Norethindrone
Plasma Levels After Single Oral Dose
14
Norethindrone 1000 µg
12
Levonorgestrel 150 µg
10
8
6
4
2
0
0
6
12
18
24
30
Hours After Administration
36
42
Stanczyk FZ. In: Lobo RA, ed. Treatment of the Postmenopausal Woman: Basic and Clinical
Aspects. Raven Press,1994.
48
www.contraceptiononline.org
Drugs That Decrease the Effectiveness of OCs
 Anticonvulsants
 Barbituates (including
phenobarbital and
primidone)
 Anti-infectives
 Rifampin
 Griseofulvin
 Phenytoin
 Carbamazepine
 Toprimate
 Vigabatin
American College of Obstetrics and Gynecology Practice Bulletin Number 18, July 2000
www.contraceptiononline.org
Drugs That Do Not Decrease the Effectiveness of
OCs
 Anti-infectives
 Tetracycline
 Doxycycline
 Ampicillin
 Metrondiazole
 Quinolone antibiotics
American College of Obstetrics and Gynecology Practice Bulletin Number 18, July 2000
www.contraceptiononline.org
Noncontraceptive Benefits of OCs
 Cycle-related:
 Cancer reduction:
 Irregular cycles
 Ovarian
 Dysmenorrhea
 Endometrial
 Menorrhagia
 Colorectal
 Anemia
 Functional ovarian
cysts
Adapted from Grimes DA et al, eds. Modern Contraception: Updates from
The Contraception Report. Emron;1997:1-100
www.contraceptiononline.org
Noncontraceptive Benefits of OCs
 Prevention of:
 Bone loss
 Fibrocystic/benign
breast disease
 Pelvic inflammatory
disease (PID)
 Ectopic pregnancy
 Treatment of:
 Acne
 Hirsutism
 Perimenopausal
symptoms
Adapted from Grimes DA et al, eds. Modern Contraception: Updates from
The Contraception Report. Emron, 1997.
www.contraceptiononline.org
Community-Based Hospital-Based
Case-Control
Case-Control
Cohort
Studies Show OCs Reduce Risk of
Ovarian Cancer
Hildreth et al,
Rosenberg et al,
La Vecchia et al,
Tzonou et al,
Booth et al,
Hartge et al,
WHO,
Wu et al,
Prazzini et al,
Newhouse et al,
Casagrande et al,
Cramer et al,
Willet et al,
Weiss,
Risch et al,
CASH,
Harlow et al,
Shu et al,
Walnut Creek,
Vessey et al,
Beral et al,
1981
1982
1984
1984
1989
1989
1989
1988
1991
1977
1979
1982
1981
1981
1983
1987
1988
1989
1981
1987
1988
Summary of RR with
ever-use of OC:
0.64 (95% CI, 0.57-0.73)
0.0
0.5
1.0
1.5
2.0
Relative Risk
2.5
3.0
3.5
Hankinson SE et al. Obstet Gynecol. 1991;80:708-714.
www.contraceptiononline.org
Ovarian Cancer and OCs
Risk Reduction by Years of Use
10.0
CASH, 1987
Relative Risk
(log scale)
La Vecchia et al, 1986
Wu et al, 1988
Beral et al, 1988
1.0
0.1
1
2
3
4
5
6
7
8
Years of OC Use
9
10
11
12
Adapted from Grimes DA et al, eds. Modern Contraception: Updates from
The Contraception Report. Emron, 1997.
www.contraceptiononline.org
OCs Protect Against Ovarian Cancer
After Discontinuation
10.0
CASH, 1987
Relative Risk
La Vecchia et al, 1986
Rosenberg et al, 1982
WHO, 1989
1.0
0.1
.5
1
5
1–4
5
5–9
10
Years Since Last OC Use
Stanford JL. Contraception. 1991;43:543-556.
www.contraceptiononline.org
OCs Reduce Risk of Ovarian Cancer in
High-Risk Women
 BRCA1 and BRCA2 mutations increase ovarian
cancer risk
 45% increased risk in carriers of BRCA 1
 25% increased risk in carriers of BRCA 2
 OCs reduce ovarian cancer risk in carriers
of BRCA1 or BRCA2
 20% reduction with short-term OC use (3 y)
 60% reduction with long-term OC use (6 y)
Narod SA et al. N Engl J Med. 1998;339:424-428.
www.contraceptiononline.org
Cohort
Case Control
Studies Show OCs Reduce Risk
of Endometrial Cancer
Horwitz et al,
Weiss et al,
Kaufman et al,
Kelsey et al,
Hulka et al,
Henderson et al,
La Vecchia et al,
Pettersson et al,
CASH,
Koumantaki et al,
WHO,
Brinton et al,
Jick et al,
Ramcharan et al,
Trapido,
Beral et al,
1979
1980
1980
1982
1982
1983
1986
1986
1987
1989
1991
1983
1993
1981
1983
1988
0.0
0.5
1.0
1.5
2.0
Relative Risk
Adapted from Grimes DA et al. Am J Obstet Gynecol. 1995;172:227-235.
2.5
3.0
3.5
www.contraceptiononline.org
OCs Reduce Risk of Endometrial Cancer
By Years of Use
Yr
4
8
12
Relative Risk
10
RR
0.44
0.33
0.28
1
CASH, 1987
Levi et al, 1991
Stanford et al, 1993
Hulka et al, 1982
Kaufman et al, 1980
Weiss et al, 1980
0.1
0.01
0
2
4
6
8
10
12
Total Years of OC Use
Adapted from Schlesselman JJ. Hum Reprod. 1997;12:1851-1863.
www.contraceptiononline.org
OCs Protect Against Endometrial Cancer
After Discontinuation
Yr
5
10
20
Relative Risk
10
1
La Vecchia, 1986
CASH, 1987
Levi et al, 1991
Stanford et al, 1993
Hulka et al, 1982
Kaufman et al, 1980
Weiss et al, 1980
0.1
0.01
RR
0.33
0.41
0.51
0
2
4
6
8
10
12 14 16 18
Years Since Last Use of Combined OCs
20
22
24
Adapted from Schlesselman JJ. Hum Reprod. 1997;12:1851-1863.
www.contraceptiononline.org
Ovarian and Endometrial Cancers and
Low-Dose OCs
 Ovarian cancer
 If protective effect is due to prevention of
“incessant ovulation,” low-dose OCs are likely
protective
 Endometrial cancer
 Data on protective effect indicate no significant
difference between 35 µg and >50 µg EE OCs
Cancer and Steroid Hormone Study/CDC/NICHHD. JAMA. 1987;257:796-800;
Rosenblatt KA et al. Eur J Cancer. 1992;28A:1872-1876.
www.contraceptiononline.org
Bone Mass and OC Use
Studies Examining Association
 9/13 studies show positive effects
 Up to 12% increase in BMD vs. control subjects
 Greatest protection with OC use of 10 y
 Primarily an estrogen effect; progestins
may be important
 4 studies show neutral effect
 No studies show decreased BMD with OC use
Kuohung W et al. Contraception. 2000;61:77-82.
www.contraceptiononline.org
Higher Bone Density
More Likely in OC Users
OC users
Non-OC users
100
80
60
40
20
0
4
1
2
3
(High)
(Low)
Bone Mineral Density Quartile
Kleerekoper M et al. Arch Intern Med. 1991;151:1971-1976.
www.contraceptiononline.org
Higher Bone Density
Association With Longer OC Use
0.6
Relative Risk of Low Bone Density
0.5
0.4
0.3
0.2
0.1
<2
2–4
4–6
6–8
8–10
>10
Years of OC Use
Kleerekoper M et al. Arch Intern Med. 1991;151:1971-1976.
www.contraceptiononline.org
Do 20 µg EE OCs Increase Bone
Mineral Density?
 20 µg EE OCs: significant increases in vertebral
bone density (oligomenorrheic, perimenopausal
women)
 0.625 mg conjugated equine estrogens (HRT) =
~ 5 µg EE
 5 µg EE doses: demonstrate bone-sparing
properties
 20 µg EE OCs: protective benefits are
maintained in perimenopausal women
www.contraceptiononline.org
Acne
 Androgen-stimulated disorder
 All OCs:
 Are antiandrogenic
 Reduce free testosterone
 Improve acne for most women
www.contraceptiononline.org
Acne Improvement with OCs
% Improvement
90
82
80
70
70
60
50
48
40
30
20
76
80
Physician Global Assessment
% Improvement
Patient Assessment
90
80
70
63
60
50
40
30
20
10
10
0
0
Placebo
83
90
Norgestimate
Levonorgestrel
Allen HH et al. In: Update on Triphasic Oral Contraception. Excerpta Medica, 1982:82-99;
Lemay A et al. J Clin Endocrinol Metab. 1990;71:8-14; Loudon NB et al. Update on Triphasic
Oral Contraception. 1982:75-81; Redmond GP et al. Obstet Gynecol. 1997;89:615-622; Wishart
JM. Australas J Dermatol. 1991;32:51-54.
www.contraceptiononline.org
Reductions in Inflammatory
Lesion Counts at Cycle 6*
EE 35 µg/NGM (Ortho Tri-Cyclen) vs. Placebo
Mean Change
5
Study 1
Study 2
0
-5
-8
-10
-10
-12
P<.05
P<.05
-15
EE 35 ug/NGM
Placebo
*A negative change indicates improvement.
Redmond et al. Obstet Gynecol. 1997;89:615-22; Lucky AW et al. J Am Acad Dermatol. 1997;37:746-754.
www.contraceptiononline.org
Reductions in Total Lesion Counts at Cycle 6*
EE 35 µg/NGM (Ortho Tri-Cyclen) vs. Placebo
5
Study 1
Study 2
Mean Change
0
-5
-10
-14
-15
-19
-20
-25
-28
-29
-30
P<.05
P<.05
-35
EE 35 ug/NGM
Placebo
*Negative change indicates improvement.
Redmond et al. Obstet Gynecol. 1997;89:615-22; Lucky AW et al. J Am Acad Dermatol. 1997;37:746-754.
www.contraceptiononline.org
Reductions in Inflammatory Lesion Counts at Cycle 6
EE 20 µg/LNG 100 µg (Alesse) vs. Placebo
Mean % Change
5
Study 1
Study 2
0
-5
-7
-8
-10
-10
-15
-12
P<.05
P<.05
EE 20 ug/LNG 100 ug
Placebo
Lemay A et al. Gyneco Endocrinol. 2000;14:RT61; Leyden JJ et al. American Academy of Dermatology. March
2001;Washington, DC.
www.contraceptiononline.org
Reductions in Total Lesion Counts at Cycle 6
EE 20 µg/LNG 100 µg (Alesse) vs. Placebo
5
Study 1
Study 2
Mean % Change
0
-5
-10
-16
-15
-20
-25
-18
-25
-26
P<.05
P<.05
-30
-35
Alesse
Placebo
Lemay A et al. Gyneco Endocrinol. 2000;14:RT61; Leyden JJ et al. American Academy of Dermatology. March
2001;Washington, DC.
www.contraceptiononline.org
How OCs Improve Acne
  Ovarian and adrenal
androgen secretion
  SHBG to bind androgens
Free
testosterone
  5-reductase activity
van der Vange N et al. Contraception. 1990;41:345-352; Cassidenti DL et al.
Obstet Gynecol. 1991;78:103-107.
www.contraceptiononline.org
Primary Dysmenorrhea
Incidence
Wilson (n=88)
Grade
0 (none)
Mean age 15
Sundell (n=460)
Age 19
Age 24
9%
28%
33%
1 (mild)
27%
35%
35%
2 (moderate)
41%
23%
22%
3 (severe)
23%
15%
10%
Absenteeism*
26%
51%
34%
* Missed classes or work.
Wilson CA et al. J Adolesc Health Care. 1989;10:317-22;
Sundell G et al. Br J Obstet Gynaecol. 1990;97:588-94.
www.contraceptiononline.org
OC Use in Adolescents
Decreased Dysmenorrhea and Compliance
 Reduction of dysmenorrhea was the most
statistically and clinically significant predictor of
consistent OC use
 Adolescents with severe dysmenorrhea who
experienced positive effects (decreased cramping
or flow) were 8 times more likely to be consistent
pill users (missed 3 pills per month) than others
Robinson JC et al. Am J Obstet Gynecol. 1992;166:578-583.
www.contraceptiononline.org
Primary Dysmenorrhea
 50% of women and 80% of adolescents report
pain with menses
 OCs reduce menstrual fluid volume and
prostaglandin levels
 OCs provide marked improvement of symptoms
 NSAIDs complement OC use
Dawood MY. J Reprod Med. 1985;30:154-67;Wilson CA et al. J Adolesc Health Care. 1989;10:317-22.
www.contraceptiononline.org
How OCs Improve Primary Dysmenorrhea
 By ovulation inhibition, progesterone-stimulated
endometrial prostaglandin production is reduced
 By reducing menstrual flow, which contains
prostaglandins
www.contraceptiononline.org
OC Compliance
A Real Concern with Adolescents
 Daily pill taking habit difficult
 Cost considerations
 Obtaining refills
 Misinformation about the pill
www.contraceptiononline.org
Reported Pill Use vs. Actual Pill Use
60
Diary
% Women
(Age 18 y)
50
Electronic
device
40
30
20
10
0
0
1
Cycle 1
2 3
0
1
2 3
Cycle 2
Active Pills Missed
0
1
2 3
Cycle 3
Reproduced with permission from Potter L et al. Fam Plann Perspect. 1996;28:154-158.
www.contraceptiononline.org
Pill-Taking Behaviors by Age
<=14
15-17
18-19
20-24
25-29
>=30
100
90
80
Percent'
70
60
50
40
30
20
10
0
Takes a pill qd
Takes pill
same time qd
Takes pills in
same order
Uses backup
if forgets
Takes only
own pills
Oakley D et al. Fam Plann Perspect. 1991;23:150-154.
www.contraceptiononline.org
Continuation Rate
(per 100 women enrolled)
OC Continuation Rates
All Ages
OC switchers
All OC users
New OC starts
100
95
90
85
80
75
70
65
60
55
50
0
1
2
3
4
Study Month
5
6
Reproduced with permission from Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582.
www.contraceptiononline.org
Reasons for OC Discontinuation
All Ages
Method difficulty
14%
Clinician
recommended
9%
Side effects
37%
Other
17%
No need
23%
Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582.
www.contraceptiononline.org
What Happens When
Women Discontinue OCs
 42% discontinue without consulting their health-
care provider
 19% discontinue without selecting another
contraceptive method
 69% choose a less-effective contraceptive method
Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582.
www.contraceptiononline.org
Patients at Risk for BTB
 First-time users
 Inconsistent users
 Users at risk for chlamydial cervicitis and
endometritis
 Smokers
www.contraceptiononline.org
Breakthrough Bleeding in OC New Starts
35 µg EE OC vs. Two 20 µg EE OCs
Bleeding Index
25
20
35 µg EE
(Ortho
Tri-Cyclen)
15
20 µg EE
(Alesse and
Mircette)
10
No significant differences
5
0
1
2
3
Cycle
4
Adapted from Rosenberg MJ et al. Contraception. 1999;60:321-329.
5
6
www.contraceptiononline.org
Breakthrough Bleeding in OC Switchers
35 µg EE OC vs. Two 20 µg EE OCs
Bleeding Index
25
20
35 µg EE
(Ortho
Tri-Cyclen)
15
10
20 µg EE
(Alesse and
Mircette)
No significant differences
5
0
1
2
3
4
5
6
Adapted from Rosenberg MJ et al. Contraception. 1999;60:321-329.
www.contraceptiononline.org
OC Formulations and BTB
 Rates reported for different OCs are highly
variable depending on study design and other
factors
 Few randomized, prospective studies directly
compare BTB between OCs
 Data do not support perception that 20 µg EE OCs
generally have more BTB than 30–35 µg EE OCs
Lynch CM. Contemporary OB/GYN. 2000 (suppl)
www.contraceptiononline.org
BTB May Signal Chlamydia
 Chlamydial infections are common in women of
childbearing age — detected in 9.2% of female
military recruits
 BTB in women previously well regulated on OCs is
an added marker for chlamydial infection
 29% of OC users with BTB tested positive for
Chlamydia trachomatis vs. 11% without BTB
but at high risk
Gaydos CA et al. N Engl J Med. 1998;339:739-744; Krettek JE et al. Obstet Gynecol. 1993;81:728-731.
www.contraceptiononline.org
Smoking Affects Rates of BTB
% With Spotting/Bleeding
60
*
Smokers
50
Nonsmokers
* P<.01
40
30
20
*
*
*
*
*
10
0
1
2
3
4
5
6
Cycle
Reproduced with permission from Rosenberg M et al. Am J Obstet Gynecol. 1996;174:628-632.
www.contraceptiononline.org
Adolescents’ Anticipated vs. Reported Side Effects
EE 20 µg/LNG 100 µg Formulation
60
Anticipated at baseline
Reported at 6 months
Percent
50
40
30
20
10
0
Weight gain Spotting
Nausea
Breast
Mood Headaches
tenderness changes
Rosenthal SL et al. 12th World Congress of Pediatric & Adolescent Gynecology. June 1998;Helsinki, Finland.
www.contraceptiononline.org
Relative Risk of Estrogen-Related Side Effects
35 µg EE OC vs. Two 20 µg EE OCs
Side Effect
Relative Risk of
35 vs. 20 g EE OCs
(Ortho Tri-Cyclen vs.
Alesse and Mircette)
Breast tenderness
1.5*
Nausea
1.6*
Bloating
1.4*
*P<.05.
Rosenberg MJ et al. Contraception. 1999;60:321-329.
www.contraceptiononline.org
Side Effects of EE 20 µg/LNG 100 µg (Alesse) vs.
Placebo: No Significant Difference
Alesse
Placebo
P-Value
(n=349)
%
(n=355)
%
(Fisher’s
Exact)
Headache
31.5
30.1
.74
Nausea
14.0
11.3
.31
Weight gain
3.4
2.3
.37
Breast pain
4.6
3.1
.33
Adverse
event
Hordinsky M et al. 8th World Congress of the International Society of Gynecological Endocrinology.
December 2000. Florence, Italy.
www.contraceptiononline.org
Weight Gain Is Not A Trivial Concern
for OC Users
 Adolescents
 Major fear leading to discontinuation
 85% of suburban teens cited weight gain as an
important concern
 Adult women
 Common reason for self-initiated
discontinuation
Emans SJ et al. JAMA. 1987;257:3337-3381; Pratt WF et al. Fam Plann Perspect.
1987;19:257-266.
www.contraceptiononline.org
Women’s Perceptions About Weight Gain
and OCs
In a survey of 704 women aged 18-45 years:
 20% report fear of weight gain is a reason they
would not take or stop taking OCs
 27% of those who had never taken OCs say,
among other reasons, this was because of fear of
weight gain
 17% of current or previous OC users cite fear of
gaining weight as a reason for discontinuation
NANPWH Survey. 1999.
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Controlled Studies Fail to Show Weight
Gain Linked to OC Use
Goldzieher et al,
1971
Placebocontrolled,
double-blind
crossover
(N=380)
Weight gain (5 lb)
occurred in approximately
25% of women; no significant
difference between placebo
and OC groups (50 µg EE)
Reubinoff et al,
1995
Prospective,
randomized
(N=49)
No statistical difference
in weight gain (0.5 kg)
between OC users and
nonusers (30 µg EE)
Hordinsky et al,
2000
Placebocontrolled,
double-blind
crossover
(N=721)
No statistical difference
in mean weight change after 6 mo
between OC users and nonusers
(EE 20 µg/LNG 100 µg, Alesse)
Goldzieher JW et al. Fertil Steril. 1971;22:609-623; Reubinoff BE et al. Fertil Steril. 1995;63:516521; Hordinsky M et al. 8th World Congress of the International Society of Gynecological
Endocrinology. December 2000. Florence, Italy.
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The Press Underreports Studies of
OC Benefits
Media emphasizes negative rather than positive
news about OCs
 1986-1997: 9 studies
on OC health effects
published in N Engl
J Med and JAMA
 All studies showed
positive health effects
 8 out of 9 studies
ignored by major
newspapers
Lebow MA. Obstet Gynecol. 1999;93:453-456.
Copyright © 1989 by the New York Times Co. Reprinted by permission.
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Management of Side Effects
Preventive/Anticipatory Guidance
 Acknowledge that side effects can be bothersome
and uncomfortable
 Discuss breakthrough bleeding, nausea, weight
gain at initial visit
 Set realistic expectations and counsel
 Most side effects improve over time
 Acne improvement is not immediate
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How to Improve Successful Use of OCs
 Emphasize the many noncontraceptive benefits
 Cue pill-taking to daily activity
 Provide spare pack; advise to keep as
emergency backup
 Provide written instructions
 Train office contact person to respond to calls
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Improving Successful OC Use
Anticipatory Guidance
 Individualize counseling to patient’s concerns
and history
 Breakthrough bleeding
 Amenorrhea
 Side effects decrease over time
 Demonstrate how to use the actual pill pack
 Missed pills
 “Don’t stop taking the pills before calling me”
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Adolescent Counseling
 Caution that OCs do not prevent STDs
 Discuss condom use: “How are you protecting
yourself from AIDS?”
 Ask how she plans to discuss condom use with
her partner
 Discuss emergency contraception
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Depo Provera (3-month shot)
 Synthetic progesterone
 Private
 Requires clinic visit Q 3 months
 Effective in 24 hours
 Side Effects
 Contraindications
 Unexplained vaginal bleeding
 pregnancy
Comparison of New
Contraceptive Methods
Implant
Intrauterine
system
Ring
Patch
Yes
Yes
Yes
Yes
Yes
1 month
Insertion &
removal
Insertion &
removal
Prescript
ion
Prescription
Easily
reversible
Yes
Yes
Yes
Yes
Yes
Dosing
frequency
1 month
3-5 yrs
5 yrs
Every 4
weeks
Weekly
Usercontrolled
No
No
No
Yes
Yes
Discreet
Yes
Sometimes
Yes
Yes
Sometimes
Efficacious
Office Visits
Monthly
injectable
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Contraceptive Implant: Implanon
 Single implant rod (4 cm in length
and 2 mm in diameter) made of
ethylene vinyl acetate
 Contains 68 mg of etonogestrel
(3-keto-desogestrel), the active
metabolite of desogestrel
 Effective for 3 years
 Inhibits ovulation during the entire
treatment period
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Implanon Efficacy, Safety and Tolerability
 No pregnancies in 1,200 women-years of exposure
 Good safety profile
 Irregular bleeding is most common adverse effect
 Requires clinician visit for initiation and
discontinuation
 Single implant systems using newer progestins may
solve some of the adverse effects and problems
presented by earlier implants
Zheng SR, et al. Contraception. 1999;60:1-8.
Croxatto HB, et al. Hum Reprod. 1999;14:976-81.
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Levonorgestrel Intrauterine System:
Mirena
 Releases 20 g of
levonorgestrel per 24 hrs
 Duration: 5 years
 Packaged with sterile inserter
 High efficacy
 Pearl Index of 0.1
(This is a schematic and is not
anatomically proportional.)
Lahteenmaki P, et al. Steroids. 2000;65:693-697.
www.contraceptiononline.org
Mirena Cycle Control,
Safety, and Tolerability
 Requires clinician visit for initiation and
discontinuation
 Early spotting
 Significant reduction in menstrual blood loss and
high rate of amenorrhea
 High rates of continuation
Hidalgo M, et al. Contraception. 2002;65:129-132.
Lahteenmaki P, et al. Steroids. 2000;65:693-697.
www.contraceptiononline.org
Vaginal Ring: NuvaRing
 NuvaRing releases 15 g of
ethinyl estradiol and 120 g of
etonogestrel daily
 Worn for 3 out of 4 weeks
 Self insertion and removal
 Pregnancy rate 0.65 per 100
woman–years
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
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NuvaRing Efficacy
Women
Treatment cycles
Pregnancies
Pearl Index
(95% CI)
Intention
to-Treat
1,145
Following
Protocol
1,019
12,109
9,880
6
3
0.65 (0.08–1.16) 0.40 (0.24–1.41)
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
www.contraceptiononline.org
NuvaRing Cycle Control and Tolerability
 Good cycle control

Irregular bleeding was rare
(2.6% - 6.4% of evaluable cycles)

Withdrawal bleeding occurred
(97.9% - 99.4% of evaluable cycles)
 Well tolerated and well accepted by users and their
partners (only 5% of partners objected to use)
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
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NuvaRing Compared to OC:
Irregular Bleeding
*
40
NuvaRing
Combined oral
contraceptive
30
20
10
0
1
2
3
4
Cycle Number
5
6
*P<0.001 for COC vs NuvaRing
Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186:389-395.
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Contraceptive Patch: Ortho Evra
 Patch contains 6 mg norelgestromin
and 0.75 mg ethinyl estradiol
 Delivers continuous systemic doses
of hormones
 150 µg norelgestromin (NGMN)
 20 µg ethinyl estradiol (EE)
Per day
 Direct comparisons to oral
contraceptive delivery doses cannot
be made
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Ortho Evra Efficacy and Compliance
 High Efficacy
 Overall Pearl Index of 0.88
 After 6 cycles, overall pregnancy possibility is half that of OC
users
 May be less efficacious in women 198 lb (90 kg)
 NIH study in progress
 Compliance is superior with Ortho Evra compared to OC
 Ortho Evra compliance unaffected by age
 Lower compliance with OC in younger compared with older
subjects
Audet MC, et al. JAMA. 2001;285:2347-2354.
Zieman M, et al. Fertility and Sterility 2002;77:S13-8.
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Ortho Evra Compared to OC:
Breakthrough Bleeding*
% of patients
20
18
Patch
16
Oral contraceptive
14
12
10
8
6
3.7 4.2
4
2.9
4.5
2.7
1.3
2
0
3.1
3
1
3
6
Cycle
9
2.4
0
13
*The differences in the treatment groups were not statistically significant
Audet MC, et al. JAMA. 2001;285:2347-2354.
©2001, American Medical Association.
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Ortho Evra Compared to OC: Adverse
Events
Patch (n=812)
OC (n=605)
Overall
Treatment
limiting
Overall
Treatment
limiting
Breast
discomfort
19%
1.0%
6%
0.2%
Headache
22%
1.5%
22%
0.3%
Application site
reaction
20%
2.6%
NA
NA
Nausea
20%
1.8%
18%
0.8%
Abdominal pain
8%
0.2%
8%
0.3%
Dysmenorrhea
13%
1.5%
10%
0.2%
Audet MC, et al. JAMA. 2001;285:2347-2354.
www.contraceptiononline.org
Conclusions
 Clinicians should not assume they know what a
woman’s contraceptive needs are
 After listening to a woman’s concerns, counseling
should be non-directive and informative
 A menu of contraceptive options should be presented
to all reproductive-aged women
 Consider using computer-based instruction or
videos before the clinician consult to optimize
education
 With good counseling, women will select a
contraceptive method that best suits their needs
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