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

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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

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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

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Based

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C

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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

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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

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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

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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?