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PANELISTS
Dr Asha Bhatt Dr Dipti PatelDr Bharat Rangani Dr Tejal Shah Dr Pooja Nadkarni
A newly married girl comes to you for information about contraception.
How would you approach this client in terms of contraception counselling & choice?
Recognize the patient’s goals for control of fertility
Identify the patient’s health risks that result in some methods being preferred over others
WHO CATEGORY 4Determine the patient’s ability to
consistently and correctly use the preferred method
Why efficacy depends on correct and consistent use
Why methods fail, even with proper use
Why long-term methods tend to have lower failure rates
Why using two methods simultaneously is more effective than using one alone
Why emergency contraception is a last chance to prevent pregnancy
What are the usual barriers to consistent and correct use of a contraceptive method?
Experience with the methodFears and misunderstandingsAbility to remember and use the
methodTolerance of side effectsCultural, social, or moral concernsPartner (or parental) objections
How can we help in overcoming these barriers?
Listen actively Assume nothing
Objective listening offers a common ground
Your patient may have more ways to solve her problems than you will
Believe that your patient knows what she wants
Respect your patient’s right to privacy
Hatcher R, et al, eds. Contraceptive Technology. 18th rev ed. 2004.
Patient information handouts- Correcting misperceptions Non contraceptive health benefits
Daily alarm on a computer, personal digital assistant (PDA), or cell phone
Encourage her to call if she has questions or concerns
Myths &
misperceptions??
Cause cancer Cause blood clots Are associated with weight gain Should not be taken by women over the
age of 35 Disrupt an existing pregnancy if taken
inadverently. Makes woman infertile Changes sexual behaviour Build up in a woman’s body. Women need a
“rest” from taking cocs.
Goldzieher JW, et al. Fertil Steril. 1971;22:609-623; Reubinoff BE, et al. Fertil Steril. 1995;63:51 Gallo MF, et al. Cochrane Database Syst Rev. 2006;(1):CD003987.
Goldzieher et al.,1971
Placebo-controlled double-blind crossover (N=380)
Reubinoff et al.,1995
Prospective, randomized (N=49)
No statistical difference in weight gain (0.5 kg)between users of oral contraceptives (30 g EE) and nonusers
Weight gain (5 lb) in ~ 25% of women; no significant difference between the placebo group and the users of oral contraceptive ( 50 g ethinyl estradiol [EE])
Gallo et al.,2006
Systematic review of randomized controlled trials
No association between combination oral contraceptives and weight gain
Oelkers W, et al. J Clin Endocrinol Metab. 1995;80:1816-1821.
EE = ethinyl estradiolDRSP = drospirenoneLNG = levonorgestrel
3 6 7-2.0
-1.5
-1.0
-0.5
0
0.5
1.0
Month
Mea
n C
han
ge
in B
od
y W
eig
ht
(kg
)
30 µg EE/3 mg DRSP20 µg EE/3 mg DRSP15 µg EE/3 mg DRSP30 µg EE/0.15 mg LNG
0
20
40
60
80
100
Food and Drug Administration. FDA Talk Paper. Nov. 24, 1995.
Esti
mate
d A
vera
ge R
isk/
10
0,0
00
Wom
en
/Year
Non-Oral Contraceptive
Users
Oral Contraceptive
Users
Pregnant Women
Results of a large epidemiologic study suggest that oral contraceptives do not cause breast cancer
Breast cancer risk in women who have not taken oral contraceptives for ≥10 years is the same as those who have never used them
There is a slightly increased risk of diagnosis in current users of oral contraceptives and in those who stopped taking them ≤10 years ago
Tumors are more likely to be localized in oral contraceptive users than in nonusers
Collaborative Group on Hormonal Factors in Breast Cancer. Lancet.1996;347:1713-1727; Collaborative Group on Hormonal Factors in Breast Cancer. Contraception. 1996;54:1S-106S.
Improvement of cycle-related conditions: Acne Irregular
menstrual cycles Dysmenorrhea Menorrhagia Anemia Functional
ovarian cysts
Reduction in cancer of certain organs: Ovary Endometrium Colon and
rectum
Wallach M, et al., eds. Modern Oral Contraception: Updates from The Contraception Report. Emron, 2000.
Hankinson SE, et al. Obstet Gynecol. 1991;80:708-714.
0.0Relative Risk
0.5 1.0 1.5 2.0 2.5 3.0 3.5
Summary of relative risk with ever-use of an oral contraceptive: 0.64 (95% CI, 0.57-0.73)
Hosp
ital-
Based
C
ase-C
on
trol S
tud
yC
om
mu
nit
y-B
ased
C
ase-C
on
trol S
tud
yC
oh
ort
Stu
dy
Hildreth et al., 1981Rosenberg et al., 1982La Vecchia et al., 1984
Tzonou et al., 1984Booth et al., 1989
Hartge et al., 1989 WHO, 1989
Wu et al., 1988Prazzini et al., 1991
Newhouse et al., 1977Casagrande et al., 1979
Cramer et al., 1982Willet et al., 1981
Weiss, 1981Risch et al., 1983
CASH, 1987Harlow et al., 1988
Shu et al., 1989Walnut Creek, 1981Vessey et al., 1987
Beral et al., 1988
3.5
Adapted from Grimes DA, Economy KE. Am J Obstet Gynecol. 1995;172:227-235.
Horwitz et al., 1979Weiss et al., 1980
Kaufman et al., 1980Kelsey et al., 1982Hulka et al., 1982
Henderson et al., 1983La Vecchia et al., 1986Pettersson et al., 1986
CASH, 1987Koumantaki et al., 1989
WHO, 1991Brinton et al., 1983
Jick et al., 1993Ramcharan et al., 1981
Trapido, 1983Beral et al., 1988
Relative Risk0.0 0.5 1.0 1.5 2.0 2.5 3.0
Case C
on
trol
Coh
ort
Michaelsson K, et al. Lancet. 1999;353:1481-1484.
0.1
1
10
Control Over 4030-39Under 30
Age (Y) at First Oral Contraceptive Use
Odds
Rati
o
Which type of pill would you prefer for this healthy newly married girl without any contraindications for OCPs?
Estrogen dose Type of progesterone
Mono/triphasic
Low doseV.low dose
*Not available in the United States.
19-Nortestosterone19-Nortestosterone
GonanesGonanes
LevonorgestrelLevonorgestrel NorgestrelNorgestrel
DesogestrelDesogestrel NorgestimateNorgestimate GestodeneGestodene
EstranesEstranes
NorethindroneNorethindrone Norethindrone Norethindrone
acetateacetate Ethynodiol Ethynodiol
diacetatediacetate NorethynodrelNorethynodrel LynestrenolLynestrenol
DrospirenoneDrospirenone
Spironolactone
Adapted from Sulak PJ. OBG Management. 2004;Suppl:3-8.
Triphasic oral contraceptives contain increasing doses of estrogen or progestin throughout the menstrual cycle in order to decrease adverse events
A Cochrane review of triphasic and monophasic oral contraceptives found: Comparable efficacy Suggestion of less spotting, breakthrough
bleeding, and amenorrhea with triphasic oral contraceptives
van Vliet HA, et al. Cochrane Database Syst Rev. 2006;3:CD003553.
A 42 yr old woman on 20 micgm EE pill for last 2 months comes to you with breakthrough bleeding.
Expressing concern about ocpills in general & at her age in particular
Overall health good,non smoker,no CVS risk factors,normotensive, BMI 25
How would you approach her breakthrough bleeding?
Breakthrough bleeding….. DEFINITION?
E ? P ? 21/7 vs 24/4 vs extended cycle
bleeding that is unscheduled, that occurs outside the time of the hormone-free interval, and also is not within the first 3 to 4 days of active pills within a given OC cycle. Currently, many people feel that the better term to use is 'unscheduled bleeding.'between 10% and 30% of women will have some spotting in the first 2 months of OC use. The high proportion of the spotting or abnormal bleeding will usually disappear by the
third month.
Any woman beginning a new form of hormonal contraception
Women who inconsistently use oral contraceptives or miss doses
Oral contraceptive users who have chlamydial cervicitis and/or endometritis Infection is the likely cause when
breakthrough bleeding appears several months after initiating an oral contraceptive regimen
Smokers, possibly because of fluctuations in estrogen levels
Vomiting or diarrhea Taking anticonvulsants or rifampicin Wallach M, et al., eds. Modern Oral Contraception: Updates from The Contraception Report. 2000.
Rosenberg MJ, et al. Am J Obstet Gynecol. 1998;179:577-582.
0
2
4
6
8
10
12
IrregularBleeding
Nausea Weight Gain
Mood Changes
Breast Tenderness
Headaches
% D
isco
nti
nu
ing
A 20-year-old woman would like to begin OC use, but has an older sister whose severe migraine headaches began when she started OC use. The patient reports a personal history of mild headaches occurring 6 to 8 times yearly for the past 4 years. These last 3 to 4 hours and are bilateral, pressing, or tightening in quality, and not associated with nausea, vomiting, photophobia, or phonophobia. The headaches respond well to over-the-counter medications such as NSAIDs. Her neurologic examination is normal and there are no other contraindications to OC use.
Safety. There is no evidence that TTH is a risk factor for the development of ischemic stroke.
Tolerability. There is no evidence that hormonal fluctuations play a role in the pathogenesis or clinical course of TTH. There is modest evidence that a family history of migraine increases the risk of developing headache on OCs.
Guidelines. TTH is not considered a contraindication to OC use by any professional guidelines.
While the presence of TTH does not contraindicate OC use in this patient, the strong family history of migraine does increase the risk that she will develop new-onset migraine with OC use
weighing the potential benefits of OC use and the strength of other reasons for OC use against the small but real risk of headache precipitation
A 23-year-old woman has severe dysmenorrhea that has been unresponsive to treatment with NSAIDs. She has migraine without aura and takes sodium valproate 250 mg twice daily for migraine prevention. Because she desires contraception, OCs have been recommended as treatment of dysmenorrhea. The patient has heard through friends and the popular press that because she has migraine she should not use OCs. Her neurologic examination is normal and she has no other contraindications to OC use.
Safety. Migraine and OC use are both risk factors for ischemic stroke. The risk of stroke in childbearing age women is low, but good quality evidence suggests that a diagnosis of migraine without aura increases this risk by a factor of about 3. The combination of migraine and OC use increases the risk of stroke by a factor of about 14. Stroke risk appears to be higher with OCs containing high doses of estrogen (greater than 50 µg of ethinyl estradiol).
Interestingly, migraine appears to be a risk factor for stroke only in women under the age of 45.
Tolerability. OCs are widely believed to cause or aggravate headache, but the evidence that this is a common or clinically significant problem is remarkably slim.
Regardless of cause, headache occurring in association with OC use tended to improve despite continued OC use.
Migraine in women using traditional COCs is more likely to occur during the pill-free week, presumably triggered by estrogen withdrawal.
OCs containing lower levels of estrogen may be less likely to provoke headache
There is no evidence that the dose or type of progestin in an OC has an important influence on headache
Guidelines.World Health Organization (WHO)
and American College of Obstetrics and Gynecology (ACOG) guidelines consider that for women under the age of 35 who have migraine without aura, and few or no cardiovascular risk factors, the benefits of OC use typically outweigh the risks
The International Headache Society task force on combined OCs and hormone replacement therapy in women with migraine concluded that "there is no contraindication to the use of COCs in women with migraine in the absence of migraine aura or other risk factors.
Recommendations This patient has migraine without aura, is
under 35, has no additional risk factors for stroke, and is likely to experience important improvement in another condition from OC use. Avoidance of unintended pregnancy is especially important in this patient because she is taking valproate, a known teratogen.For her, the benefits of OC use probably outweigh the drawbacks, and this assessment is supported by professional guidelines.
It would be wise to obtain a baseline assessment of the frequency, severity, and character of this patient's headaches and then monitor their frequency and severity while she is using OCs.
Estrogen-progestin combinations (8%)
Progestin-only (8%)
Prevent unintended pregnancy
Yes
Minimize hormonal fluctuations
Yes
Provide additional health benefits
Decreased risk of ovarian/ endometrial cancers
Bone protection Cycle control
Grimes DA, Wallach M, eds. Modern Contraception: Updates from The Contraception Report. 1997; Hatcher RA, Nelson AL. In: Contraceptive Technology. 2004:391-460.
*Percentage of women experiencing unintended pregnancy with typical use within first
year of use.
Shortened menstrual cycleDecreased variability in mensesLess severe bleedingReduced incidence and duration of
clotting/flooding
Casper RF, et al. Menopause. 1997;4:139-147.
*Minestrin™ = 20 µg of ethinyl estradiol plus 1 mg of norethindrone acetate
Reproduced with permission from Casper RF, et al. Menopause. 1997;4:139-147.
EE = ethinyl estradiol; NETA = norethindrone acetate
Endpoint in Menopause-Specific Quality-of-Life Questionnaire
-5
0
5
10
15
20
Ch
an
ge f
rom
Baselin
e (
%)
Placebo20-g EE/1-mg NETA
* **
NS
Global PsychosocialPhysicalSexual
*P<0.01NS=not significant
75
80
85
90
95
100
105
0 6 12 18 24 30 36
Oral ContraceptivesControl
Months of Use
% B
on
e M
ass
Shargil AA. Int J Fertil. 1985;30:15-28.
Reference Standard
Determine when an oral contraceptive is no longer needed Measure follicle-stimulating hormone and/or estradiol
levels after being off of oral contraceptives for 2 weeks ▪ Serial elevations in follicle-stimulating hormone
levels indicate menopause in most women Estimate age of menopause based on onset of
perimenopausal symptoms Arbitrarily stop between the ages of 50 and 52
Transition to hormone therapy may be indicated in some women
Premenstrual molimina Normal premenstrual discomfort,
nonproblematic Most common premenstrual disorder
Premenstrual Syndrome (PMS) Bothersome adverse somatic and/or affective
symptoms during the luteal phase Premenstrual Dysphoric Disorder (PMDD)
Significant impairment Least common premenstrual disorder
Ginsburg KA, Dinsay R. In: Ransom SB, ed. Practical Strategies in Obstetrics and Gynecology. Philadelphia: W.B. Saunders Company; 2000:684-694; Kessel B. Obstet Gynecol Clin North Am. 2000;27:625-639.
Affective Symptoms Somatic Symptoms
Irritability†
DepressionAngry outburstsAnxietyConfusionSocial withdrawal
Breast tendernessAbdominal bloatingHeadacheSwelling of extremities
ACOG=American College of Obstetricians and Gynecologists*Limited core of symptoms; †Hallmark affective symptom
Adapted from ACOG Practice Bulletin No. 15. Obstet Gynecol. 2000;95(4): supplemental material at end of issue.
• Other disorders must be excluded • Must include dysfunction in social or economic performance• Symptoms must be present in the absence of pharmacologic
therapy, hormone ingestion, or drug or alcohol use
Core Symptoms• Depressed mood • Anxiety, edginess, nervousness• Moodiness • Anger or irritability
Other Symptoms• Physical symptoms (headache, breast tenderness and/or
swelling, bloating, joint/muscle pain, etc.)• Fatigue, lethargy • Decreased interest in• Insomnia/hypersomnia usual activities• Difficulty concentrating • Feeling overwhelmed/• Appetite changes/cravings out of control
• Must have ≥ 5 symptoms, including at least 1 core symptom• Symptoms must occur during the last week of the luteal phase• Symptoms are relieved within a few days of starting menses
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association, 2000.
Calendar of Premenstrual Experiences (COPE) Symptom calendar 4-point Likert scale 10 physical and 12 behavioral symptoms
Premenstrual Symptoms Screening Tool (PSST) 19-item questionnaire Rating scale with degrees of severity for DSM-IV symptoms
Visual Analogue Scale (VAS) 100-mm vertical line (“no symptoms” to “severe” symptoms) Irritability, tension, depression and mood swings
Daily Record of Severity of Problems (DRSP) 24-item questionnaire Symptoms and functional impairment 6-point scale
Feuerstein M, Shaw WS. J Reprod Med. 2002;76:279-289; Steiner M, et al. Arch Women Ment Health. 2003;6:203-209; Steiner M, et al. J Affect Disord. 1999;53:269-273; Endicott J, et al. Arch Womens Ment Health. 2006;9:41-49.
PMS=premenstrual syndrome; PMDD=premenstrual dysphoric disorder
Lifestyle changes Aerobic exercise Dietary modification
Cognitive-behavioral therapy Pharmacologic agents
Selective serotonin reuptake inhibitors (SSRIs) The SSRIs that have an FDA-approved indication for
treating premenstrual dysphoric disorder are:▪ Fluoxetine hydrochloride▪ Sertraline hydrochloride▪ Paroxetine hydrochloride
Spironolactone Anxiolytics Gonadotropin-releasing hormone (GnRH) agonists Hormonal contraceptives
ACOG Practice Bulletin No. 15. Obstet Gynecol. 2000;95(4): supplemental material at end of issue.
Exercise Regular aerobic
exercise reduces premenstrual syndrome, possibly due to release of endorphins
Recommendation: 20–30 minutes/day of aerobic exercise at least 3 days per week
Ginsburg KA, Dinsay R. Premenstrual syndrome. In: Ransom SB, ed. Practical Strategies in Obstetrics and Gynecology. Philadelphia: W.B. Saunders Company, 2000:684-694; Thys-Jacobs S, et al. Am J Obstet Gynecol. 1998;179:444-452; Sayegh R, et al. Obstet Gynecol. 1995; 86:520-528; Freeman EW, et al. Int J Gynaecol Obstet. 2002;77:253-254.
Dietary supplements
Calcium supplements have modest effects on symptoms
Limited data indicate a possible benefit of a beverage containing complex and simple carbohydrates
Agent Results
CBT vs. notreatment1
4 weeks of group CBT superior to no treatment (placebo) forreducing PMS severity; gains maintained up to 18 months
CBT vs. IFT2 CBT and IFT equally effective for reducing premenstrual levels of negative mood and physical changes; effectsmaintained at 12 months
CBT vs. fluoxetinevs both3
All treatments equally effective at 6 months. Fluoxetinetherapy had more rapid effect. No added benefit for combining treatments
CBT vs. notreatment4
CBT more effective than no treatment for reducing PMSsymptoms, associated impairments and depression
PMS=premenstrual syndrome; CBT=cognitive-behavioral therapy; IFT=information-focused therapy (training in relaxation, assertion, and child management, nutritional/vitamin guidelines, dietary/lifestyle changes)
1. Taylor D. Res Nurs Health. 1999;22:496-511.2. Christensen AP, Oei TP. J Affect Disord. 1995;33:57-63.3. Hunter MS, et al. J Psychosom Res. 2002;53:811-817.4. Blake F, et al. J Psychosom Res. 1998;45:307-318.
0
5
10
15
20
25
Wang M, et al. Acta Obstet Gynecol Scand. 1995;74:803-808.
BaselineBaseline
SpironolactoneSpironolactone
PlaceboPlacebo
Vis
ual A
nalo
gu
e S
cale
*†
**
*†
*P<0.01 vs. baseline†P<0.01 vs. placebo
Anxiety, Tension, Irritability, Fatigue,
Depression
Cheerfulness, Well-being, Friendliness,
Energetic Feeling
Headache, Feeling of Swelling, Craving of
Sweets, BreastTenderness
Anxiolytic agent 0.25 mg once or twice daily in luteal
phase; dose should be tapered at menses
Studies have given inconsistent results Contraindicated in women with a
history of drug abuse or dependence Sedation bothersome for some women
ACOG Practice Bulletin No. 15. Obstet Gynecol.2000;95(4): supplemental material at end of issue.
-35
-30
-25
-20
-15
-10
-5
0
MoodSymptoms
PhysicalSymptoms
SocialFunctioning
Total DRSPScore
Cohen LS, et al. Obstet Gynecol. 2002;100:435-444.
Mean
Ch
an
ge f
rom
Baselin
e
in D
aily
Record
of
Severi
ty o
f S
ym
pto
ms
Fluoxetine 10 mg
Fluoxetine 20 mg
Placebo
†
*
*
* *
†
*P<0.01; †P<0.05
DRSP=Daily Record of Severity of Problems
Standard estrogen and progestin combination contraceptives in a 21/7 regimen show no or minimal improvement to symptoms
Decline in endogenous estradiol levels during the last week of hormonal contraception may be responsible for the estrogen-withdrawal symptoms beginning to appear during the last week, thus exacerbating premenstrual-type symptoms during the subsequent 7-day hormone-free interval
AgentStudy Type Results
Monophasic ethinyl estradiol/ desogestrel Monophasic ethinyl estradiol/ levonorgestrel Triphasic ethinyl estradiol/ levonorgestrel
RCT1 Mood scores improved from baseline for all 3 OCs Benefit no different than that seen with placebo in other studies
Ethinyl estradiol/norethindrone RCT2 Decreased premenstrual breast pain and bloating compared with placebo No beneficial effect on mood
Various OCs NCCS3 No effect on mood
21/7=21 days of an active hormone followed by a 7-day hormone-free interval; OC=oral contraceptive; RCT=randomized, controlled trial; NCCS=nested case-control study
1. Backstrom T, et al. Contraception. 1992;46:253-2682. Graham CA, Sherwin BB. J Psychosom Res.1992;36:257-2663. Joffe H, et al. Am J Obstet Gynecol. 2003;189:1523-1530.
Cycle-Related Symptom
N=262
P Value21 Active
Days7 Hormone-Free Days
Pelvic pain 21% 70% <0.001
Headache 53% 70% <0.001
Breast tenderness 19% 58% <0.001
Bloating/swelling 16% 38% <0.001
Needing pain meds 43% 69% <0.001
Sulak PJ, et al. Obstet Gynecol. 2000;95:261-266.
21/7=21 days of an active hormone followed by a 7-day hormone-free interval
0
0.1
0.2
0.3
0.4
0.5
Headache Anxiety
Avera
ge S
core
on
DS
R17*
Item
168-day cycle
28-day cycle
Irritability Mood SwingsSwelling, Bloating,
Weight Gain
Depression
*DSR17=Penn State Daily Symptom Report; †P<0.0001; §P=0.0001.
Coffee AL, et al. Am J Obstet Gynecol. 2006;195:1311-1319.
††
†
† † §
-24
-20
-16
-12
-8
-4
0
1 2 3 1 2 3 1 2 3
*Factor scores comprised of individual items from the Daily Record of Severity of Problems (DRSP). PMDD=premenstrual dysphoric disorder; EE=ethinyl estradiol.
Yonkers KA, et al. Obstet Gynecol. 2005;106:492-501.
Ch
an
ge f
rom
Baselin
e
Physical Mood Behavioral
†P=0.01 vs. placebo§P=0.001 vs. placebo
Drospirenone-EEPlacebo
††
†
†
†
† †
§
§
*Not available in the United States.
Contraceptive ProgestinsContraceptive Progestinsin Current Usein Current Use
Levonorgestrel Levonorgestrel FamilyFamily
(Gonanes)(Gonanes)
LevonorgestrelLevonorgestrel NorgestrelNorgestrel DesogestrelDesogestrel NorgestimateNorgestimate Gestodene*Gestodene*
Norethindrone Norethindrone FamilyFamily
(Estranes)(Estranes)
NorethindroneNorethindrone Norethindrone Norethindrone
acetateacetate Ethynodiol Ethynodiol
diacetatediacetate Lynestrenol*Lynestrenol*
Spironolactone-Spironolactone-DerivedDerived
DrospirenoneDrospirenone
Women with contraindications for combination hormonal contraceptives, including a history of: Venous thrombosis Vascular disease Hypertension Heavy smoking (>35 years)
Lactating womenHeinemann LA, et al. Eur J Contracept Reprod Health Care. 1999;4:67-73; Tankeyoon M, et al. Contraception. 1984;30:505-522.
The efficacy rate of progestin-only pills is comparable to combination oral contraceptives, but consistently timed ingestion is required Plasma levels fall to baseline after 24
hours If ingestion occurs more than 3 hours
after a required dose, back-up contraception should be used for 48 hours
21 Active Days
7 Hormone-free 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 pain meds 43% 69% <0.001
Sulak PJ, et al. Obstet Gynecol. 2000;95:261-266.
N=262
Brand NameEstrogen
DoseProgestin Dose Regimen
Seasonale® 30 µg EE 150 µg levonorgestrel 84/7
SeasoniqueTM 30 µg EE 150 µg levonorgestrel84/7*
*7 days 10 µg EE
Yaz 20 µg EE 3 mg drospirenone 24/4
Loestrin 24 Fe
20 µg EE1 mg norethindrone acetate
24/4*
*4 days of iron
Lybrel 20 µg EE 90 µg levonorgestrel365 days (non-cyclic daily dosing)
EE= ethinyl estradiol
0
0.5
1
1.5
2
Conventional Extended-cycle
Perc
en
tag
e o
f W
om
en
0
5
10
15
Conventional Extended-cycle
Perc
en
tag
e o
f W
om
en
PregnancyDiscontinuations Due to Adverse Event(s)
Anderson FD, Hait H. Contraception. 2003;68:89-96.
*30 µg ethinyl estradiol/150 µg levonorgestrel
0
2
4
6
8
10
12
1 2 3 4
Anderson FD, Hait H. Contraception. 2003;68:89-96.
Med
ian
Nu
mb
er
of
Bre
akth
rou
gh
B
leed
ing
/Sp
ott
ing
Days/C
ycle
CycleDay 1-84 92-175 183-266 274-357
*30 µg ethinyl estradiol/150 µg levonorgestrel.
Premenstrual symptomatology
Menstrual migraine headaches
Menorrhagia, irregular bleeding Anemia
Endometriosis Pain Infertility
Dysmenorrhea
Ovarian cysts Perimenopausal
symptomatology Shorter cycles Cycles further
apart and lighter Adolescent
symptomatology Facial acne Menorrhagia
Hematologic conditions Anemia Bleeding disorders Clotting defects
Developmental disabilities Professional/social obligations
Military service Professional athletics Performing arts (e.g., ballerinas) Vacation/honeymoon
-7 0 7 14 21 28
Cycle day
0
1
Estra
dio
l Levels
Red = Typical pattern during spontaneous menstrual cycle
Black = theorized pattern duringOCP cycle with 7 day HFI
Intitiation of Hormonewithdrawal symptoms on OCP
Initiation of hormone withdrawal symptoms during spontaneous cycle
Slide courtesy of Thomas J. Kuehl, PhD
36 women used triphasic, 30-µg monophasic, or 20-µg monophasic oral contraceptives for three consecutive cycles
Transvaginal ultrasound was performed every three days to monitor ovarian follicular development If a follicle reached ≥14 mm, each subject had a
daily sonogram and a serum estradiol measurement
Results: Follicles develop to an ovulatory diameter during the hormone-free interval
Baerwald AR, et al. Contraception. 2004;70:371-377.
Randomized double-blind study (N=60) 20 µg ethinyl estradiol (EE)/75 µg gestodene 21/7 regimen vs. 23/5 regimen 5 cycles (1 pretreatment, 3 treatment, 1 posttreatment) Ovarian suppression, assessed by follicular development
and EE levels, was more pronounced with the 23/5 regimen
Randomized investigator-blinded controlled trial (N=54) compared 3 cycles of 3 combination oral contraceptives:
▪ 21/7 regimen of 20 µg EE/100 µg levonorgestrel▪ 21/2/5 regimen of 20 µg EE/placebo/10 µg EE▪ Continuous 20 µg EE/150 µg desogestrel
The difference among the three groups was statistically significant (P=0.005)
Spona J, et al. Contraception. 1996;54:71-77. Schlaff WD, et al. Am J Obstet Gynecol. 2004;190:943-951.
Brand NameEstrogen
DoseProgestin
Dose Regimen
Seasonale® 30 µg ethinyl estradiol
150 µg levonorgestrel
84/7
SeasoniqueTM 30 µg ethinyl estradiol
150 µg levonorgestrel
84/7*
*7 days 10 µg ethinyl estradiol
Yaz20 µg ethinyl estradiol
3 mg drospirenone
24/4
Loestrin 24 Fe20 µg ethinyl estradiol
1 mg norethindrone acetate
24/4*
*4 days of iron
In a prospective analysis, patients who experienced >7 consecutive days of breakthrough bleeding/spotting were counseled to: Take a 3-day hormone-free interval and resume the
extended regimenOR Continue the extended regimen If bleeding/spotting was unresolved after seven days,
take a 3-day hormone-free interval and then resume the extended regimen
All patients whose breakthrough bleeding/spotting continued despite either intervention were counseled to: Institute a 3-day hormone-free interval after another
seven days of bleeding/spotting but not before 14 days had passed since the previous 3-day hormone-free interval
Sulak PJ, et al. Am J Obstet Gynecol. 2006;195:935-941.
Prospective analysis of bleeding among women (N=111) taking a 21/7 pre-extension regimen followed by a 168-day extended regimen of an oral contraceptive containing 30 µg ethinyl estradiol/3 mg drospirenone
During the extended cycle: Continuation of active pills usually resulted in
continued flow with a greater tendency to require a 3-day hormone-free interval
Taking a 3-day hormone-free interval resulted in an initial increase in flow usually followed by a cessation of flow after a few days
Sulak PJ, et al. Am J Obstet Gynecol. 2006;195:935-941.
Patients do not have to adhere to a fixed cycle (e.g., 49 days, 91 days)
Patients should expect breakthrough bleeding and spotting. If either occurs, patients should chose one of the following options: Option A:
▪ Keep taking active pills as spotting/bleeding will decrease over time
Option B:▪ Take a 3- to 4-day hormone-free interval, relabel
the pill pack to the correct day of the week, and restart active pills
The option chosen should be based on the significance of the bleeding/spotting and the severity of the hormone withdrawal symptoms a patient experiences
Adolescents may benefit from a regimented extended cycle because they may have difficulty determining when to take a hormone-free interval (i.e., to allow withdrawal bleeding) if on a flexible oral contraceptive schedule Consideration of their preferences may promote
initiation and continuation Cost may be an issue, unless the adolescent
purchases both pills and personal hygiene products
Adolescents must understand that although there is a reduction in bleeding days, unscheduled bleeding occurs more often, but it decreases with continued use
Schwartz JL, et al. Contraception. 1999;60:263-267;den Tonkelaar I, Odden BJ. Contraception. 1999;59:357-362;Omar H, et al. J Pediatr Adolesc Gynecol. 2005;18:285-288.
Vercellini P, et al. Fert Steril. 2003;80:560-563.
Study population Women who underwent endometriosis surgery within one year
Recurrent dysmenorrhea despite cyclic use of oral contraceptives
Intervention Continuous ethinyl estradiol (0.02 mg) and desogestrel (0.15 mg) for two years
Outcomes Reduction in frequency/severity of dysmenorrhea
80% of women satisfied
12% reported relief of menstrual migraines
0
15
30
45
60Ages 18–24 years (n=101)
Ages 25–29 years (n=45)
Ages 30–39 years (n=150)
Once/ month
Every other
month
Once/ 3 months
Once/6 months
Pe
rce
nta
ge
of
Re
sp
on
de
nts
Ages 40–49 years (n=195)
Once/year
Never
Association of Reproductive Health Professionals.
Harris Poll, June 14-17, 2002.
Choices* N=551
Increase risk of breast cancer 7%
Increase risk of deep vein thrombosis/pulmonary embolism
13%
Create future fertility problems 3%
Affect none of the above 83%
Sulak PJ, et al. Contraception. 2006;73:41-45.
Extended Oral Contraceptive Regimens: Extended Oral Contraceptive Regimens: Attitudes of Health-Care Professionals Attitudes of Health-Care Professionals Toward Associated RisksToward Associated Risks
*Respondents could check multiple responses.
Choices* N=551
Has health benefits and is necessary
12%
Only serves to reassure a woman that she is not pregnant
49%
Is unnecessary and has no health benefits
52%
Sulak PJ, et al. Contraception. 2006;73:41-45.
Extended Oral Contraceptive Regimens: Extended Oral Contraceptive Regimens: Attitudes of Health-Care Professionals Attitudes of Health-Care Professionals Toward Monthly BleedingToward Monthly Bleeding
*Respondents could check multiple responses.
Choices N=551
No 19%
Yes, but rarely 19%
Yes, occasionally 36%
Yes, frequently 24%
Yes… 2%
Sulak PJ et al. Contraception. 2006;73:41-45.
Extended Oral Contraceptive Regimens: Extended Oral Contraceptive Regimens: Prescribing Patterns of Health-Care ProfessionalsPrescribing Patterns of Health-Care Professionals
Current and future extended-cycle contraceptive methods will favorably affect menstruation, associated hormone-withdrawal symptoms, and pregnancy risk
Decreased incidence of hormone-withdrawal symptoms Reduced bleeding No development of functional ovarian cysts Decreased number of unintended pregnancies
Counseling patients regarding alterations in menstruation and safety is critical to initiation and continuation of these contraceptive methods
Breakthrough bleeding and spotting should be expected and can be managed
Long-term risks of such regimens are not known
Topical Agents Comedolytics
- Retinoids- Salicylic acid (in
many OTC agents) Antimicrobials
- Benzoyl peroxide - Clindamycin - Erythromycin/
combination
Systemic Agents
Oral antibiotics - Tetracycline- Minocycline - Doxycycline- Clindamycin
Vitamin A derivatives- Oral isotretinoin
Hormonal therapies- Oral contraceptives- Spironolactone
OTC = over the counter
Zaenglein AL, Thiboutot DM. Pediatrics. 2006;118:1188-1199.
Mild Acne Moderate Acne
SevereNodular AcneComedonal
Papular/ Pustular
Papular/ Pustular Nodular
First-line Therapy
Topical retinoid
Topical retinoid +
BPO or BPO/AB
Topical retinoid ± oral antibiotic + BPO or BPO/AB
Oral isotretinoin
AlternativesSalicylic
acidOral
isotretinoin
Topical retinoid ± oral antibiotic + BPO or
BPO/AB
Alternatives for Female Patients
Hormonal therapy + topical retinoid ± BPO or BPO/AB
Hormonal therapy + topical retinoid ± BPO or BPO/AB
Hormonal therapy + oral antibiotic + topical retinoid ± BPO or
BPO/AB
Maintenance Therapy
Topical retinoid ± BPO or BPO/AB
Topical retinoid ± BPO or BPO/AB
Topical retinoid ± BPO or BPO/AB
Zaenglein AL, Thiboutot DM. Pediatrics. 2006;118:1188-1199.
AB = topical antibiotic; BPO = benzoyl peroxide
Androgen secretion in the ovaries and adrenal glands through their estrogenic effects Production of testosterone Levels of free testosterone Production of dihydrotestosterone
Sex hormone-binding globulin to bind androgens
5-reductase activity
van der Vange N, et al. Contraception. 1990;41:345-352; Cassidenti DL, et al. Obstet Gynecol. 1991;78:103-107.
-80
-60
-40
-20
0
InflammatoryLesion Counts
Total Lesion Counts
EE/DRSP = ethinyl estradiol 30 µg/drospirenone 3 mg; EE/NGM=ethinyl estradiol 35 µg/norgestimate 180-215-250 µg
Thorneycroft IH, et al. Cutis. 2004;74:123-130.
Me
an
Ch
an
ge
EE/DRSPEE/NGM
Cycle 6
May be more effective for inflammatory lesions (papules, pustules, nodules) than noninflammatory ones (comedones)
May be used concurrently with topical agents
May be used as ongoing maintenance therapy
Thiboutot D. Arch Fam Med. 2000:9:179-187; Usatine RP, et al. Prim Care. 2000;27:289-308; Wallach M, Grimes DA. In: Modern Oral Contraception: Updates from The Contraception Report. 2000:155-168.
Before, during, and after isotretinoin (Accutane) ...[E]ffective contraception must
be used for at least 1 month before beginning Accutane therapy, during therapy, and for 1 month following discontinuation of therapy….
...[I]t is critically important that women of childbearing potential use two effective forms of contraception simultaneously…..
Accutane [package insert], 2000 (Revised. May 2000).
Treat mild to moderate acne Topical/systemic agents as appropriate
Prescribe oral contraceptives for women with acne who also need contraception Counsel women that most oral contraceptives improve acne
for most women Counsel women not to discontinue previously prescribed
topical or oral agents when oral contraceptives are initiated Refer patients with severe acne to a dermatologist
If the dermatologist prescribes isotretinoin (Accutane), a potential teratogen, counsel women on contraception before, during, and after the drug’s use
Oral contraceptives provide additional benefits
Accutane [package insert], 2000 (Revised. May 2000); Thiboutot D. Arch Fam Med. 2000:9:179-187; Usatine RP, et al. Prim Care. 2000;27:289-308; Wallach M, et al. In: Modern Oral Contraception: Updates from The Contraception Report. 2000.
There have been 3 OCs that have gained FDA approval for an indication for the treatment of mild-to-moderate acne. As I mentioned before, it is the triphasic norgestimate pill, the estraphasic norethindrone acetate pill, and most recently, the 24-4 20-mcg [estrogen]/DRSP pill.
A 37-year-old mother of 2 comes to your office because she is interested in starting an OC.
Her medical history – a benign fibroadenoma in her left breast 10
years ago postpartum depression after having her first
child. Her younger sister was diagnosed with breast cancer at the age of 26, but otherwise her family history is unremarkable. Her physical examination shows BP 129/76 mm Hg, pulse 79 beats per minute, BMI 31 kg/m2
Given this patient's age, which of the following characteristics would be a reason for not recommending a combined OC on the basis of current recommendations?
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