female contraception-latest development-pansy lam

8/3/2019 Female Contraception-Latest Development-Pansy Lam

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THE LATEST DEVELOPMENTON FEMALE CONTRACEPTION

Dr Pansy W.Y. Lam


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Definitions:

Pearl Index number of pregnancy in 100 women

in 1 year Cumulative pregnancy rate in number of years

Failure rate~ Pregnancy rate


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Various methods of contraception

Combined Pills (COC)

Contraceptive Injection

Contraceptive implant

Transdermal Patch

Progestogen only pills

Intra-uterine Systems (LNG-IUD)

Condoms

Spermicides

Diaphragms

Intra-uterine Devices (IUD)

Sterilization - male and

female

Natural family planning


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Efficacy of various contraceptive methods commonly used in US &

Western Europe

*The total number of unplanned pregnancies which occur per 100 womanyears of use

1. The Gallup Organization Inc. 2004; 2. Skouby 2004; 3. Leidenberger 1998; 4. Baltzer et al. 1985;

5. Ortho-McNeil Pharmaceutical Inc. 2001; 6. Ortho-McNeil Pharmaceutical Inc. 2002

Reliability Contraception type Pearl Index*

Very high Combined oral contraceptives 0.032.36

Very high Transdermal patch ~1.0

Highvery high Mini-pill (progesterone only) 0.44.3

Reasonable Male condom 714

Unreliable Coitus interruptus (Withdrawal) 1040


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Combined OC pills

Actions

Pearl index of 0.1

Inhibit FSH and LH secretions thus preventingovulation

Thicken cervical mucus to prevent sperm penetrating

uterus

Endometrial thinning to prevent fertilized egg

implantation


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Combined OC pills

Other uses

Good cycle regulator

Menorrhagia - reduce mean menstrual blood loss

Dysmenorrhoea

Endometriosis Premenstrual syndrome

PCOS

Acne


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Categorization of Combined OC pills

Categories Estrogen dose/day Progestogen

1st generation 50ug/day levonorgestrel

2nd generation 20 - 35ug/day levonorgestrel

or norgestrel

3rd generation 20 - 30ug/day desogestreland gestodene

New generation 20 - 30ug/day Drospirenone(DRSP)


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Combined OC pills

Preparation

Monophasic 21, 21/7, 22/6, 24/4, 84/7

Biphasic 2 types of combined E+P

Triphasic 3 types of combined E+P

No advantage in biphasic and triphasic preparations


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Estrogens

Side effects dose dependent

Coagulation- stroke, DVT ( especially in smoker)

Lipid problem ( inc HDL and lower LDL) Breast tenderness

Water retention and weight gain

Depression-serotonin reduction

GIT condition- nausea and vomiting

Photosensitive

Breast cancer?

Liver tumour risk?


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Progestogenic

activity

Antiandrogenic

activity

Antimineralo-

corticord activity

Glucocorticord

activity

Progesterone + (+) + -Drospirenone + + + -

Cyproterone acetate + + - (+)

Desogestrel + - - -

Dienogest + + - -

Gestodene + - (+) -

Levonorgestrel + - - -

Norgestimate + - - -

+ effect, (+) negligible at therapeutic dosages, - no effect

Pharmacological Profile of Progestogens


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Risks of Oral Contraceptives:

Nonfatal Venous Thromboembolism

Food and Drug Administration. FDA Talk Paper. Nov. 24, 1995.

EstimatedAverageRisk/

100,0

00Women/Year

Healthy Non-OCUsers

Users of OCs Pregnant Women0

20

40

60

80

100

515 (2

nd

generation)

25 (3rd

generation)

60


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Cardiovascular Mortality Risk with Smoking and Age in

COC Users

Oral contraceptive user

Oral contraceptive nonuser

SmokerNonsmoker SmokerNonsmoker

< 35 years of age 35 years of age

Casesper100

,000Woman-Years

AttributableRisk/100,000

User-Years

0.06 1.73 3.03 19.4

Sherif K.Sherif K.Am J Obstet Gynecol.Am J Obstet Gynecol. 1999;180(Pt 2):S3431999;180(Pt 2):S343--S348.S348.

0

5

10

15

20

25

30


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Cardiovascular Risk On the basis of a large EU surveillance study in > 58,600 women followed-up

for over 142,400 women years, the European Agency for the Evaluation of

Medicinal Products has concluded COCs are safe and highly effective atpreventing pregnancy, and that there is no reason for women currently using

any brand of a COC to stop taking the medication - 2007

Source: Dinger JC., et al. The safety of a drospirenoneSource: Dinger JC., et al. The safety of a drospirenone --containing OC. Contraception 2007;75:344containing OC. Contraception 2007;75:344--354354


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Combined OC pills

Contraindications

Hypertension, DM, Hyperlipidaemia

Potential high risk age >35

Venous Thrombotic Embolism

Stroke

Breast cancer risk controversial

Liver tumour risk- controversial

Varicose Precaution in smoker


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New preparation with low estrogen

pills (20mcg daily)

low estrogen pills

Increase problems of BTB and spotting

Risk of failure with missed pills increased

Alternative contraception if in doubt recommended

e.g. take other drugs, missed pills frequently

New regimes of 24/4 and 84/7 regimes

Side effects varies due to different types ofprogestogen (Drosperinone, Dienogest)


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New 24/4 regime with Drospirenone

Contraindications and precautions ?Increase non-fatal venous thromboembolism actively being investigated

the same as those for other low-dose combined oral contraceptives In addition, should not be used in women with conditions that predispose to

hyperkalemia, e.g. renal insufficiency, hepatic dysfunction and adrenal

insufficiency

Women who are taking daily long-term medications that may increase

serum potassium levels

Such agents include angiotensin converting enzyme (ACE) inhibitors, angiotensin-

II receptor antagonists, potassium-sparing diuretics, potassium supplementation,

heparin, aldosterone antagonists and non-steroidal anti-inflammatory drugs

(NSAIDs)


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Other new preparation Seasonale:

Levonorgestrel-015mg + ethinylestradiol-30mcg Extended cycle regime- 84 days with 7 pill-free

days

Pearl Index- 1.0 HWY Less PMS

Precaution with estrogen related condition

attention with smoker / DM/ hypertension More spotting can occur


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Other new prepapration Dienogest (DNG) with estradiol valerate (E2V)

Dynamic-estrogen step down and progestogen stepup sequence good cycle control

DNG- strong progestogenic and low androgenic

effect

Highly endometrial selective

Low estrogenic and androgenic


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Dienogest (DNG)

with Estradiol Valerate (E2V)

Reliable contraception- Pearl Index- 0.42

Shorter withdrawal bleeding duration Less irregular spotting

Lighter period - useful for abnormal menstrual

bleeding Well tolerated -Satisfactory rate- 79.5%


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DNG/E2

V preparation Less metabolic effect including haemostatic parameters- Prothrombin and

D-Dimer

Inc HDL and lower LDL

No change to CHO metabolism

Less acne

Better vaginal surface cell maturation

Same endometrial stimulation and FSH suppression effects (as other lowdose OCP)

Well tolerated -Satisfactory rate- 79.5%


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OC Discontinuation:

Impact of Side Effects In a study of 1657 women not desiring pregnancy, 32% new

starters and 16% switchers discontinued OCs due to side effects

within 6 months*.

Most common side effects leading to OC discontinuation (n=293):

Bleeding irregularities 12%

Nausea 7%

Weight gain 5% Mood change 5%

Breast tenderness 4%

Headache 4%

*Excluding women who discontinued to pursue pregnancy or were no longer in a sexual relationship

Rosenberg J, Waugh MS. Am J Obstet Gynecol. 1998;179:577-582.

Managing expectations


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Progestogen only pills (Mini-pill)

Mechanism

Progestogen effect

Thinning of endometrium

Thicken cervical mucus

?may prevent ovulation for some pills

Take it same time each day even when menstruating

Loss the contraceptive effect if 3 hours late, ?longer in

newer drugs (Cerazette)


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Progestogen only pills (mini-pills)

Applications

breastfeeding

diabetics

women who smoke

Women who could not use combined OC pills e.g.

blood pressure has gone up on the Pill

older women.


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Side effects Irregular period

Secondary amenorrhoea sometimes

May be ectopic if get pregnant (ectopics are said

to be rarer with Cerazette)

May increase pigmentation

Breast pain

Sometimes nausea, headache, dizziness, depressionand weight change.


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Transdermal Patch Ethinyl estradiol 20mcg + norelgestromin 150mcg

daily release One patch per week for 3 weeks, one patch-free

week per cycle

Apply to body including abdomen, buttock, outerarm, upper torso, exclude breast

Failure rate 0.3% perfect user and 0.9% typical

user


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Transdermal patch

Side effects and disadvantage

All the side effects of COC pills

Slightly increased risk of VTE Vs COC pills Skin irritation

May come out and loss adhesiveness


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Contraceptive injections Progestogens only

Combined estrogen + Progestogen


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Contraceptive Injections

(Progestogens only)

12-wk injection: Depo-Provera (DMPA)

8-wk injection: Noristerat or NET-EN (norethisterone) Intramuscular injections

Cumulative pregnancy rate: 0.1-0.7 % in first year,


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Actions of Contraceptive Injections Prevents ovulation

Thickens cervical mucus to prevent spermpenetration

Endometrial thinning to prevent implantation


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Progestogen only injections

Disadvantages Once given, cannot be removed and side effects may

last >3 months

Irregular bleeding in first few months, may be heavyand prolonged

Weight gain, fluid retention, increase in acne and

breast discomfort Long-acting drug may not ovulate after 6-8 months or

rarely 2 yr, not related to the length of time used

After the first few months, periods become lighter than

usual or even no periods at all (7 in 10 women afterthe injection for a year).


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Pregestogen only injection

Side effects

Stopped due to menstrual disturbance, fluid

retention, weight gain, acne, breast discomfort Late return of fertility

Reduced BMD slightly (no evidence of increased

osteoporotic fracture risk) recovery afterstopping, reassessed every 2 year

C/I :no period for six months, risk of osteoporosis,

heavy drinker, anorexia nervosa


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Combined monthly injectables

(Cyclofem)

Cyclofem, Mesigyna, Lunelle, Chinese injectable No. 1

Monthly injection of every 30 days Effectiveness (Cyclofem)

Correctly used - 1% in one year

Typically used (missed or delayed injeiton) 3% in one

year

Action: prevents ovulation + thicken cervical mucous


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Combined monthly injectables

(Cyclofem)

Mechanism: combine E+P

Contraceptive effects of estrogen + progestogen Side effects of risks of OC pills

Medroxyprogesterone 50mg micmic effects of

Depo-provera


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Side effects and disadvantages Hypertension

Smoker >35 Severe headache or migraine

Breast tenderness, dizziness, weight gain

Bleeding disorders scanty, irregular, prolonged or

no period at all

1-3 months to have period return to normal status


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Contraceptive implants A tube of 40mm long and 2mm wide

Progestogen


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Contraceptive implants

Advantages 3 years

Can breast feed Reduce

dysmenorrhoea

No missed pills


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Contraceptive implants

DisadvantagesInsert under LA

Wound site problem such as infection

Removed under LA, not immediately reversibleSide effects of progestogen

Menstrual problems: Prolonged heavy flow in the beginning

Irregular flow Secondary amenorrhoea

Fluid retention, weight gain

Breast pain

Other problems

Injection time might be forgotten

Difficult to locate after years, new type has barium filled more easilylocated


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Intrauterine device Intrauterine device Copper IUCD

Intrauterine system Hormonal IUCD


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Copper IUDs

Action

Copper IUDs prevent fertilization by immobilizing

sperms and prevent implantation by changingendometrial lining

Does not affect ovulation or the menstrual cycle.

C IUD


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Copper IUDs

Advantages and disadvantages No side effects of hormones

May increase mean menstrual blood loss May increase ascending infection, vaginal fungal

infection

Failure may result in ectopic pregnancy


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Intrauterine systems / Hormonal IUCDs

Intrauterine device

Hormonal effect of progestogen Endometrial thinning

Thicken cervical mucus

I t t i t


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Intrauterine systems

Advantages and disadvantages Originally designed for treating menorrhagia,

menstrual blood loss could be reduced dramatically Prolonged spotting in first 3-6 months after insertion

can be troublesome

Risk of ectopic pregnancy if failure still present Prolonged secondary amenorhoea can be worrying

Reversal of fertility difficult to predict


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Female Barrier Methods

Female condom

Diaphragm Cervical cap


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Female condom

5% pregnancy rate

Advantages

Prevents the spread of STD, including

HIV and AIDS. No hormonal side effects.

Can be used by people with latexsensitivities.

It can be pre-lubricated and it can be

used with oil and water-based lubricants.Disadvantages:

Sometimes difficult to insert or use.

Does not contain spermicide.

Can break or leak.

More expensive than male condoms.


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Cervical cap

The cervical cap is a rubber capshaped like a thimble, which fitsover the cervix

Advantages:

Placed days or hours before sex

The cap also uses less spermicidethan the diaphragm

Disadvantages: No means of protecting from STD

Left for a few days withspermicide may cause odour

Occasionally the cap canbecome dislodged duringintercourse rendering itineffective


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Diaphragm

A rubber cap that looks like acervical cap inserted in the

vagina and placed over thecervix with spermicide

Advantages:

5 % pregnancy if usedprobably

Disadvantages:

Does not stop the spread ofSTDs

Slight risk of Toxic Shock

Syndrome May experience difficulty

with urinating.

Safety Period / Natural Family


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Safety Period / Natural Family

Planning2-20% failure rate

Calender charting

Mucus monitoring Dry day, ~5 days after

period

Wet day (thick sticky

discharge) cervicalopening

Basal bodytemperature increased

only 1F during ovulation


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Current Prevalence of Contraception


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0

10

20

30

40

50

60

70

Male condom

Female sterilization

Intra-uterine Device (IUD)

Oral contraceptive

Rhythm

1987

1992

1997

2002

2007

Male condom

Female

sterilization

Intra-uterine

Device (IUD)

Oral

contraceptive Rhythm

1987 32.2 16.8 5.6 20.3 6.7

1992 40.0 21.9 5.9 19.8 5.9

1997 44.4 22.9 5.9 16.3 3.5

2002 54.3 16.8 10.4 9.4 3.4

2007 63.1 8.9 11.7 8.4 2.9

in Hong Kong

* Sources: KAP Survey conducted by FPA in 1987-2007


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Comparison of Contraceptive Methods

Failur

e

Rate

Efficac

y

Reversible Convenienc

e

Weight Gain

Combined Oral

Contraceptive

0.2

3

DRSP causes

no signif

weight gain

Intra-uterine

System (IUS)

0 0.2

Need to beremoved byphysician

X X

Sterilization 0 1 X X X

Contraceptive

Injection

0 1 Waiting periodof 6 to 12months

X

Intra-uterine

Device (IUD)

0.3 2

Need to beremoved byphysician

X X

Condom 2 - 15 X

Natural Family

Planning

2 - 20 X X

Source: Guillebaud J. Contraception Today 1997, 3rd Edition



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Western Europe

*The total number of unplanned pregnancies which occur per 100 womanyears of use

1. The Gallup Organization Inc. 2004; 2. Skouby 2004; 3. Leidenberger 1998; 4. Baltzer et al. 1985;

5. Ortho-McNeil Pharmaceutical Inc. 2001; 6. Ortho-McNeil Pharmaceutical Inc. 2002

Reliability Contraception type Pearl Index*

Very high Combined oral contraceptives 0.032.36

Very high Transdermal patch ~1.0

Highvery high Mini-pill (progesterone only) 0.44.3

Reasonable Male condom 714

Unreliable Coitus interruptus (Withdrawal) 1040


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Conclusion

All E+P preparations have similar risks and side

effects COC still the best drug if hormones are not

contraindicated

Progestogens only pills have their advantages butbleeding problems

IU devices can be very useful and long term

Barrier method, if probably used, effective and less

side effects with some protection of STD

S


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Suggestion

Individualize recommendation

Know your client Discuss

Make agreements


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Thank You!!Thank You!!

female contraception-latest development-pansy lam

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