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CONTRACEPTIVE UPDATES

Dr Abhay Dhanorkar

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Scope• Introduction

– Definition – History– Reproductive rights– Contraceptive scenario in India & Maharashtra

• Classification of contraceptives• Barrier methods• Oral Contraceptive Pills and Emergency Contraceptive Pills• Injectable contraceptives• Intrauterine device (IUDs) • Sterilization • Miscellaneous • Advanced contraceptive methods in pipeline

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contraceptive methods

• Preventive methods to help women avoid unwanted pregancies.

• Include all temporary and permanent measures to

prevent pregnancy.

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Aim of contraception

• Family planning to check the population growth,

• To prevent STDs like AIDS.

• To reduce the stress of pregnancy, labour & lactation

in women suffering from heart disease etc.

HISTORY

Condoms - fish bladders, linen sheaths, and animal intestines.

Spermicides condoms - linen cloth sheaths soaked in a chemical solution and dried before

using.

Condoms and diaphragms- vulcanized rubber.

Margaret Sanger - first birth control clinic in the US.

1st oral contraceptive - Enovid, was marketed in US (Frank Colton)

IUDs first manufactured and marketed in the US.

3000BC

1500

1838

1916

1960

1960s5

History contd…

Legalition of birth control for all in US, irrespective of marital status.

Hormonal birth control methods expanded to include

implants and injectables. Low-dose pills were introduced.

Emergency contraception became more widely available as a result of public awareness campaign

Rapid expansion in method availability and improvements in safety and effectiveness, including introduction of the

hormonal patch, vaginal ring, new injectables, single rod implants, and transcervical female sterilization

Barriers to access contraception remain for women world-wide.

1992

1980s -1990s

Today

Today

1972

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India – Some important landmarks

• 1951 - The National family planning program• 1965 - Lippies loop introduced• 1971 - MTP act• 1977 - Family welfare programme• 1978 - Child Marriage act• 1992 - CSSM• 1997 - RCH- I• 2005 - RCH II • 2007 - Nuvaring /NRHM Contraceptive usage has been rising gradually in India.

– In 1970 - 13% – In 1997 - 35% – In 2009 - 48% .

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• The fertility rate in India has been in long-term decline from 5.7 in 1966 to 2.62 in 2011.

• 14 Indian states have dipped below the 2.1

According to the latest health ministry data Worst TFR in Bihar (3.9) Uttar Pradesh (3.7) MP (3.3) Jharkhand (3.2)Chhattisgarh (3)Uttaranchal (2.6) Assam (2.6) Gujarat (2.5)

While achieved targeted TFR, Tamil Nadu (1.7)Kerala (1.7) Maharashtra (1.9)Delhi (1.9)

West Bengal (1.9) Karnataka (2)

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Reproductive RightsTo enable control over individual’s reproductive

lives following rights are given.1. Reproductive health as a component of overall

health.2. Reproductive decision-making for

a. Voluntary choice of marriage, family formation

b. Determination of the number, timing and spacing of one’s children

3. Enable individuals to make free and informed choices free from discrimination based on gender

4. Reproductive security, including freedom from sexual violence and coercion, and the right to privacy.

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Contraceptive Scenario in India

The current trends in family planning in India shows– High level of knowledge among eligible

couples– Low acceptance remains for spacing

methods. – Female sterilization remains the most

widely used family planning method in spite of efforts to popularise male sterilization.

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INDIA FACT SHEET, NFHS-3, 2005-06

• Family Planning Use - &• Fertility – • Smaller families -becoming the norm. • Fertility has continued to decline

– NFHS-2 – 2.9 Children – NFHS-3 – 2.7 Children.

• 14 states have reached replacement level or below replacement level fertility.

• Percentage of women with two daughters and no sons say they want no more children, – NFHS-2 – 47% – NFHS-3 – 64%.

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Declining fertility is due to• Increased use of contraception - 43% to

49% between NFHS-2 and NFHS-3. • Women ages 20-24 were married before

the legal age of marriage of 18 years– NFHS-2 - 50% – NFHS-3 - 47.4%

• Increase in median age at first birth from 19.8 to 19.2.

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Key Indicators for India from NFHS-3Marriage and Fertility NFHS -1

(1992-93)NFHS-2

(1998-99)NFHS 3

(2005-06) Urban Rural

Women age 20-24 married by age 18 (%) 54.2 50.0 47.4 29.3 56.2

Men age 25-29 married by age 21 (%) NA NA 32.2 18.1 40.3

Total fertility rate (children per woman) 3.4 2.9 2.7 2.1 3.0

Women age 15-19 who were already mothers or pregnant at the time of the survey

NA NA 16.0 8.7 19.1

Median age at first birth for women age 25-49 19.4 19.3 19.8 20.9 19.3

Married women with 2 living children wanting no more children

59.7 72.4 84.6 89.7 81.6

Two sons 71.5 82.7 89.9 92.1 88.6 One son, one daughter 66.0 76.4 87.0 92.8 85.3

Two daughters 36.9 47.0 64.1 74.7 54.4

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Key Indicators for India from NFHS-3 contd…Family Planning (currently married women, age 15–49) Current use

NFHS -1 (1992-93)

NFHS-2 (1998-99)

NFHS 3 (2005-06) Urban Rural

Any method (%) 40.7 48.2 56.3 64.0 53.0

Any modern method (%) 36.5 42.8 48.5 55.8 45.3

Female sterilization (%) 27.4 34.1 37.3 37.8 37.1

Male sterilization (%) 3.5 1.9 1.0 1.1 1.0

IUD (%) 1.9 1.6 1.7 3.2 1.1

Pill (%) 1.2 2.1 3.1 3.8 2.8

Condom (%) 2.4 3.1 5.2 9.8 3.2

Total unmet need (%) 19.5 15.8 12.8 9.7 14.1

For spacing (%) 11.0 8.3 6.2 4.5 6.9

For limiting (%) 8.5 7.5 6.6 5.2 7.2

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Key Indicators for Maharashtra from NFHS-3Marriage and Fertility NFHS -1

(1992-93)NFHS-2

(1998-99)NFHS 3 (2005-06) Urban Rural

Women age 20-24 married by age 18 (%) 53.9 47.7 39.4 29.2 49.9

Men age 25-29 married by age 21 (%) NA NA 15.0 12.6 18.9

Total fertility rate (children per woman) 2.9 2.5 2.1 1.9 2.3

Women age 15-19 who were already mothers or pregnant at the time of the survey

NA NA 13.8 9.3 18.2

Median age at first birth for women age 25-49 19.0 19.0 19.9 20.9 19.0

Married women with 2 living children wanting no more children

73.1 81.2 89.0 89.0 89.1

Two sons 81.7 93.5 95.5 93.1 97.5 One son, one daughter 79.2 85.3 92.8 91.5 94.2

Two daughters 37.6 41.4 55.1 69.2 36.5

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Key Indicators for Maharashtra from NFHS-3 contd…

Family Planning (currently married women, age 15–49) Current use

NFHS -1 (1992-93)

NFHS-2 (1998-99)

NFHS 3 (2005-06) Urban Rural

Any method (%) 54.1 60.9 66.9 66.7 67.1Any modern method (%) 52.9 59.9 64.9 64.0 65.8

Female sterilization (%) 40.3 48.5 51.1 44.2 57.5

Male sterilization (%) 6.2 3.7 2.1 1.0 3.2IUD (%) 2.5 1.9 3.0 5.3 0.8Pill (%) 1.4 1.7 2.4 3.6 1.3

Condom (%) 2.5 4.0 6.2 9.8 2.9Total unmet need (%) 14.1 13.0 9.4 9.8 9.0

For spacing (%) 7.3 8.1 5.4 5.3 5.6

For limiting (%) 6.8 4.9 3.9 4.5 3.3

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Need for Updates

The current unmet need for family planning is -12.8 % of which – For spacing - 6.2 % and – For Limiting births - 6.6 %

Two important issues in catering to the unmet demand are– Poor access to family planning services. – Poor Quality of family planning services.

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Classification of contraceptive methods

Contraceptive MethodsSpacing MethodsBarrier Methods

Intrauterine Devices

Hormonal Method

Post Conceptive Methods

Miscellaneous

Terminal methodsMale Sterilisation (Vasectomy)

Female Sterilisation (Tubectomy)

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Evaluation of contraceptive methods

Contraceptive efficiency:It is the measurement of unplanned pregnancies even

after the use of contraceptive measures.1) Pearl Index: no. Of failures/100 woman-yr of

exposureFailure rate/HWY= Total accidental pregnancies × 1200 total months of exposure2) Life table analysis: calculates a failure rate for each

month of use

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I) Barrier methods

Physical methods

Chemical methods

Combined

methods

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Physical methods

1) condoms:•Made up of fine latex sheath•Most widely used barrier in males•Highly effective if used correctly

ADVANTAGE:•Simple spacing method•No side effects•Easily available, safe & inexpensive•Protects against STDs

DISADVANTAGE:•Chances of slip off and tear offFailure rate: 2-3/HWY

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Types of condoms

1. Flavoured condoms2. Dotted condoms3. Super thin condoms

It is transparent with a thin layer made of sheerlon material that acts like a second skin. It is highly effective against pregnancy and STDs.

4. Pleasure-shaped condomsIt heightens sensitivity for both the partners. It has loose and enlarged tip.

5. Glow in the dark condomsWhen exposed to light for 30 seconds, it glows in the dark. It is non-toxic and has three layers. The inner and the outermost layers are made up of latex and the middle one contains a safe pigment that makes it glow.

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Other Advances in Male Condoms

• Desensitizing condoms with “climax control

lubricant featuring benzocaine that helps prolong

sexual pleasure and aids in prevention of

premature ejaculation” (Durex Performax, Trojan

Extended Pleasure)

• Spermicidally lubricated condoms

• Distrubution of condoms: Health worker, Asha,

Condom vending machine

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Condom Applicator

• A South African designer invented : a condom that can be applied in less than four seconds. Dubbed Pronto, the condom aims to be quicker and easier to apply than conventional brands with the hopes of encouraging more people to use them.

• The condom is contained within a foil pack -- which also acts as the applicator.

• Crack the pack in half and slip the plastic applicator apart, then roll the condom down and snap the applicator off the condom -- all in one swift movement.

• Cost -Rs.33.95 per condom.• British biotech company Futura Medical has created a

new condom, -CSD500 -coated with a vasodilator gel.

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Strong, soft, transparent polyurethane sheath inserted in the vagina before sexual intercourse

15 cm long X 7 cm diameter There is silicone-based lubricant on the condom, but additional lubrication can be used.Has two flexible rings

The outer ring , The larger, open ring stays outside

the vagina, covering part of the perineum and labia

during intercourse. The inner ring at the closed end of the condom eases insertion into the vagina, covering the

cervix and holding the condom in place

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The female condom has been available since 1992

brand names, FC Female Condom, Aastha, Velvete,Reality, Femidom, Dominique, Femy, Myfemy, Protectiv' and Care.

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Female condom instructionsA new condom every timeMake sure the condom is in place

NO male condom with a female condomInserted for up to 8 hours

Wash your hands carefully with soap and water before inserting, or removing the female condom.

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Female Condoms

How to insert the female condom ?

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How to remove the female condom?

To remove the condom, twist the outer ring and gently pull the condom out.

Wrap the condom in the package or in tissue, and throw it in the garbage. Do not put it into the toilet.

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Advantages of Female Condom• Female-controlled• No medical condition limits use.• More comfortable to men, less decrease in sensation

than male latex condoms. • Ease of use by men with erectile dysfunction.• Offers greater protection as it covers both internal

and external genitalia.• Stronger (polyurethane is 40% more stronger than

latex), and therefore there is less frequent breakage (1% compared to 4% for male condoms)

• Longer shelf-life under unfavourable storage conditions.

• CSWs found that the it allowed them to continue their job without interruption during menstruation.

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Disadvantages of Female condom

• Difficulties in insertion and removal. • Casues discomfort and inconvenience

associated with use and movement of device during use.

• More expensive than male condoms.• Failure rate – 21/HWY

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Some Evidences of FC use

• In a study in Alabama, • 25% - Unable to correctly insert in first use• 3% - Never able to do so despite additional instructions and multiple efforts.

• A study focused mainly on acceptability in 58 respondents from urban slums in Chennai and CSWs showed good acceptability in this group.

• Study conducted in the Andhra Pradesh, Kerala and Maharashtra, amongst 2 target groups, FSWs and eligible couples. For study period of 2 months, Usage levels were above 90% in both categories.

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Physical methods contd...2)diaphragm:

• Dutch cap / Fem caps

• Vaginal barrier

• Consists of a flexible ring made up of spring material to which a cup shaped synthetic rubber is attached

• Inserted into vagina over cervix

• A spermicidal jelly is always used

Failure Rate: 6-12/HWY

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Physical methods (c0ntd...)

3) Cervical cap:smaller as compared to diaphragmApplied over cervix

ADVANTAGE:•Inexpensive, •No medical consultation•Total absence of risks and medical CIs

DISADVANTAGE:•Failures are quite common•Chances of displacement high•Cervicitis and local irritationFailure rate: 11/HWY

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physical Methods (contd...)

4) VAGINAL SPONGE•Trade name ‘TODAY’

•Polyurethane foam sponge saturated with spermicide nonoxynol 9 (1gm)

•Less effective than diaphragm

Failure Rate:•20-40/HWY in multiparous•9-20/HWY in nulliparous

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Chemical barriers

Spermicidal agents which can destroy sperms when applied in female genital tract

They are available as1) Foams2) Creams. Jellies,

Paste3) Suppositories4) Soluble films

Common spermicidal agents 1) Nanoynol-92) Octoxynol-3

Failure rate: 6/HWY

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Chemical barriers (contd...)

ADVANTAGES:• Inexpensive• Well tolerated• Good protection

DISADVANTAGES:• High failure rate• Must be used immediately before intercourse• Mild burning and irritation• If used alone, not most effective in preventing

pregnancy

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classificationIUD

Medicated

Third GenerationEg. Hormonal IUD

Second GenrationEg. Copper IUD

Nonmedicated

First GenerationEg. Lippe’s loop

Intrauterine devices

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First generation iud

•They are inert or Nonmedicated devices made up of polyethylene•Different shapes and sizes

LIPPE’S LOOP:• Double ‘S’ shaped device

• Made up polyethylene material

• Non toxic, non tissue reactive & extremely durable

• Small amount of Barium Sulphate is also added for radiological examination

• Available in 4 sizes A,B,C &DFailure rate: 3-5 / HWY

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Second generation Iud•Made up of metal - copper.

EARLIER DEVICES•Copper-7•Copper-T 200

NEWER DEVICES•Variants of T device T copper 220C T copper 380A•Nova T•Multiload devices ML-Cu250 ML-Cu375Failure rate: 0.8/HWY

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Intra-uterine Contraception

GyneFix -“frameless and

flexible”= less pain and bleeding

Non-biodegradable suture thread 6 Cu tubes (5mmx2.2mm) surface area 330mm2

Special inserting device to anchor knot into fundal myometrium

Suitable for nulliparousExpulsion less than other IUDs

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Third generation iud

•Hormone releasing IUD

ProgestastertMost commonly used•T shaped device •filled with 38mg of progesterone•Releasing rate 65µg/day. •Effective for 1 yr

LNG-20 (Minera)•Releases 20µg of levonorgesterol.•Effective for 5 yrs •Effective rate 99% Failure rate: 0.2 / HWY

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IUD

Cellular and biochemical changes in Endometrium

Viability of gamete is impaired

Chances of fertilization are reduced

Copper ions

Affect uterine enzymes

Composition of cervical mucosa is altered

Hormone releasing IUD

Viscosity of cervical mucous is increased

Sperm entry is impaired

IUD

Mechanism of action of Iud

IUD EFFECTIVENESS

Progestasert 12-18 months

CuT 200 4 yrs

Nova T 5yrs

CuT 380 A 10yrs

Levonoregestrel 5 yrs

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ADVANTAGES OF IUDs:• Safe, Effective, Reversible• Inexpensive• High continuation rate

DISADVANTAGES OF IUDs:• Heavy bleeding and pain• Pelvic Inflammatory diseases• Ectopic pregnancy• May come out accidently if not properly inserted

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TIMING OF INSERTION:

• Inserted with a plunger

• Any time during women’s reproductive period

Except in pregnancy

• Most ideal time is during or within 10 days of the

beginning of menstruation the diameter of

cervical cavity is greatest at this time.

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IDEAL IUD CANDIDATE:• Who has borne at least 1 child• Has no history of PID• Has normal menstrual periods• Is willing to check IUD tail• Has an access to follow up and treatment of

potential problems• Is in monogamous relationship

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Hormonal methods

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Classification of hormonal contraceptives

Hormonal contraceptivesOral Pills

Combined pills

Progesterone only pills (POP)

Once – a – month (long acting) pills

Male pill

Depot PreparationsInjectables

Subdermal Implants

Vaginal Rings

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Hormonal control of menstrual cycle

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Oral Contraceptive and Emergency Contraceptive Pills

Combined oral contraceptive pillsA. Monophasic pills

1. Standard dose pills2. Low dose pills3. Very low dose pills

B. Multiphasic pills1. Triphasic pills2. Biphasic pills

C. Progesterone only pills/minipills

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Multiphasic pills• These were developed with the aim of reducing

the total monthly hormone intake while maintaining the efficacy.

• Biphasic pills: EE- 0.035 mg constant• Low dose progesterone first 7 days• High dose progesterone next 14 days. These

have higher failure rates and are not available in India.

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Triphasic pills:• EE- 0.03mg + LNG 0.05mg for 5 days• EE- 0.03mg + LNG 0.075mg for 10 days• EE- 0.03mg + LNG 0.125mg for 7 day• These pills have fewer side effects like amenorrhoea,

breakthrough bleeding and decreased incidence of acne.

• The drawbacks include errors in pill taking, increased failure and difficulty in postponing menstruation if required.

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Absorption of oral preparations

• Hormones are absorbed from the upper small intestine.

• Peak plasma levels reached within 2 hours • Vomiting within 2 hours of ingestion reduces the

amount of hormones absorbed, & missed pill instructions should be followed during the attack and for the next 7 days.

• In combined oral contraception, the pill free interval should be omitted if less than 7 pills remain in the packet.

• Diarrhoea (unless severe) is unlikely to affect drug levels; there are no studies showing any pharmacological basis for failure.

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Combined pills

Composition:•In early 1960s –

• Oestrogen - 100-200µg and• Progesterone - 10mg

•Greater side effects

•Nowadays • Oestrogen - 30-35µg and • Progesterone - 0.05-0.15mg.

Taken from 5th to 25th day of menstrual cycle, followed by a break of 7 days (withdrawal bleeding).•Failure rate: 0.1/HWY

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Main typeA) MALA-D: (Levonorgestrol 0.15mg + EE

0.03mg) Packet of 28 tabs. 21 are white and 7 are brown coloured containing Ferrous Fumarate.

B) MALA-N : (Levonorgestrol 0.15mg + EE 0.03mg)Packet of 28 tabs.

Govt Supply.Mechanism of action:C) Prevents ovulationD) Prevents implantationE) Makes cervical secretions thick

Effectiveness100% effective if taken correctly.

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Beneficial Effects with Combination Oral Contraceptives

• 100% effective in correct users.• Beneficial effects on menorrhagia (anemia),

dysmenorrhea, ovulatory pain, acne and hirsutism• Preventive effects on salpingitis, endometriosis,

adenomyosis and myomas• Lower the risk of endometrial, ovarian- (30-50%)

and possibly colon cancer• Preserves bone mineral density (3.3% > BMD in

premenopausal females with OCP use• May reduce the risk of ovarian cysts, rheumatoid

arthritis, benign breast disease & Ectopic preg.• May have protective effect against atherosclerosis.

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Untoward Effects with Combination Oral Contraceptives Cardiovascular effects hypertension in 5% users myocardial infarction Stroke ; ischemic or haemorrhagic DVT’s especially smokers >35, overweight and

sedentary Cancers (increase risk of) breast hepatocellular cervical Endocrine and metabolic effect, impaires glucose

tolerance and responses to glucose challenge Breast tenderness, Weight gain, Headache and migraine Special infections, HIV, HPV

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Contraindications to OCP UseAbsolute ContraindicationsCancer of breast and

GenitalsH/O venous

thromboembolismVascular disease- CAD

or CVDLiver disease ( i.e. Viral

hepatitis, cirrhosis)PregnancyCongenital

hyperlipidaemia

Relative Contraindications

Age above 40 yrs.Smoking and age

above 35 yrsHTN with SBP>160,

DBP>99Chronic renal diseasesEpilepsy , MigraineHyperlipidemia

LDL>160DM with secondary

complications Infrequent bleeding,

Amenorrhoea.

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• Postpartum women - not breastfeeding can start combined hormonal methods at 3 weeks (MEC category 2).

• Women who have additional risk factors for venous thromboembolism (VTE) generally should not start combined hormonal methods until 6 weeks after childbirth, depending on the number, severity, and combination of the risk factors (MEC category 2/3). These additional risk factors include •Previous VTE•Thrombophilia•Caesarean delivery•Blood transfusion at delivery

•Postpartum hemorrhage•Pre-eclampsia•Obesity•Smoking

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• Women with deep vein thrombosis who are established on anticoagulant therapy generally can use progestin-only contraceptives (MEC category 2) but not combined hormonal methods (MEC category 4).

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• Women with systemic lupus erythematosus generally can use any contraceptive except that:(a) A woman with positive (or unknown)

antiphospholipid antibodies should not use combined hormonal methods (MEC category 4) and generally should not use progestin-only methods (MEC category 3).

(b) A woman with severe thrombocytopenia generally should not start a progestin-only injectable (MEC category 3).

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Progesterone only pills

Minipill or Micropill.

Composition:•Low dosage of progesterone, mainly Norgestrel 0.075mg

Dosage:•One tab daily throughout the menstrual cycle•It is mainly given in older women in whom combined pills are C/I as in CVDsEfficacy 96-98%Failure rate:0.5/HWY

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Pop (contd...)Mechanism of action: Makes cervical mucosa thick – action starts in 2-4 hrs last for

24hrs. Decreases the motility of Fallopian tubes. Prevent pregnancy without preventing ovulation, as

ovulation occurs in 20-30% women.

• Suitable for Lactating women Smokers above 35 yrs old Estrogen sensitive women

Disadvantages:Higher risk of neoplasia in women taking POP than in women on

Combined Pills• Poor control of cycle.

Progesterone only contraceptives

Types

Norethindrone 350 mcg (Micronor/Noriday)

Levonorgestrel 75 mcg (Neogest)

Norgestrel 30 mcg (Microval/Norgestone)

Ethynodiol diacetate 500 mcg (Femulen)

Desogestrel 75 mcg (Cerazette).

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Post coital pills (contd...)

Mechanism of action:• Hypermotility of fallopian tube • Hypermotility of uterus hence no implantation

and fertilization

Disadvantages:Nausea and vomiting.Next period may start earlier or laterDo not protect against STI & HIV

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ECP OCP

After taking emergency contraceptive pills (ECPs)

• She can start COCs the day after she finishes taking the ECPs. There is no need to wait for her next monthly bleeding to start her pills.

• A new COC user should begin a new pill pack.• A continuing user who needed ECPs due to pill-

taking errors can continue where she left off with her current pack.

• All women will need to use a backup method for the first 7 days of taking pills.

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Instructions for missed pill

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Once a month (long acting) pill

In this method a long acting oestrogen (Quinestrol) + short acting progesterone is given

But the results are highly disappointing.

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Male pillsThe hormones which reduce sperm count tend to reduce testosterone levels hence they affect potency and libido

Gossypol:2,2 -bis-(Formyl-1,6,7-trihydroxy-5-′isopropyl-3-methylnaphthalene)•Cotton seed derivative•Causes azoospermia and severe oligospermia•Toxic•Use for 6 months leads to complete sterility

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• Estrogenic Effects– Ovulation is inhibited in part by follicle

stimulating hormone (FSH) and lutenizing hormone (LH) suppression. Therefore the pituitary does not release hormones to stimulate the ovary

– Secretions of the uterus are altered– Ovum transport is accelerated

Oestrogenic and progestrogenic effect & side effects

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• Estrogen component of OCP’s• Ethinyl estradiol (20-50 mcg)

• Estrogen Mediated Side Effects of OCP’s• Nausea • Bloating• Breast tenderness• Vascular Headaches• HTN• DVT/ Leg Pain

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• Progestational effects– Ovulation is inhibited in part by inhibition

of lutenizing hormone (LH)– A thickened cervical mucus is created

inhibiting sperm transport– Implantation is inhibited– Ovum transport may be slowed– Activation of enzymes that permit the

sperm to penetrate the ovum may be inhibited

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• Progestin component of OCP’ s • Pregnanes• Estranes• Gonanes

• Progestin Mediated Side Effects of OCP’s

• Poor control of cycle• Increase chances of neoplasm.• Lipid Abnormalities: lowers high

density lipoproteins (HDL)

Categorizations of ProgestinsProgestins

19-nortestosterone

Estranes Gonanes

NorethindroneNorethindrone acetateEthynodiol diacetate

NorgestrelLevonorgestrelNorgestimateDesogestrelGestodene

Drospirenone

17α-spirolactone

Pregnanes

Medroxy-progesterone acetateCyproterone acetateChlormadinone acetate

Progesterone

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The drugs known to have a clinicallysignificant impact on contraceptive

efficacy• Rifampicin • Griseofulvin, • Some anticonvulsants

– Topiramate, – Barbiturates, – Carbamazepine,– Primidone

• Ritonovir.

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• Women with AIDS who are treated with ritonavir- protease inhibitors, generally should not use combined hormonal methods or progestin-only pills (MEC cat 3).

• These ARV drugs may make these contraceptive methods less effective.

• These women can use progestin-only injectables, implants, and other methods.

• Women taking only other classes of ARVs can use any hormonal method.

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• Women with chronic hepatitis or mild cirrhosis of the liver can use any contraceptive method (MEC cat 1).

• Women taking medicines for seizures or rifampicin generally can use implants.

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Quick Start (also for ring, patch, Depo)

• If negative pregnancy test: swallow first pill under direct observation during visit (regardless of menstrual day).

• Give Emergency Contraception if indicated (and usually Quick Start the next day).

• Use back-up with condoms for 1 week.• Repeat pregnancy test if no withdrawal bleed, or

follow-up pregnancy test in 2-4 weeks.• Women prefer it. (81%- 97%)• Higher initiation/continuance rates.• No bleeding differences based on day of initiation.

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Quick Start contd…

• Very low pregnancy rates in first cycle with quick start even if recent unprotected intercourse (3% or lower).

• Consider the impact on initiation rate:– 100% with observed quick start.– About 75% if pills dispensed (even lower if RX

only)

• Hormonal contraceptives are not teratogenic (or abortifacients) even if pregnancy does occur.

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Oral Contraceptives: Extended Use Counseling on Safety

• Standard/traditional pill is 21 days active pills and 7 days placebo (21/7 regimen)– Monthly withdrawal bleeding is designed

to make the pill cycle feel “natural” • But, there is no ovulation on the pill• And, no menstrual lining “build up”

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Perceived Benefits of Menstruation

• Myths about monthly menstruation– Necessary for “cleansing the system”– A “natural” state– A symbol of femininity, fertility, and

youth– A sign a woman is not pregnant

• Address safety concerns of the patient (her parents or partner) before prescribing extended OCPs.

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Who might benefit from reduced frequency of menstruation?

Women with menstrual-related disorders– dysmenorrhea, menorrhagia, menstrual

migraines, cyclic breast pain…

• Athletes• Women in the military• Developmentally delayed women• Any woman who chooses to bleed less

frequently

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Seasonale

• 30 mcg EE and 150 mcg Levonorgestrel

• 84 active pills then 7 days placebo• 4 menses per year • Generic version Nordette/Levlen also

available.

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Seasonique

• Extended biphasic regimen• 84 tablets • Levonorgestrel - 0.15mg & ethinyl

estradiol - 0.03 mg • Then 7 tablets 0.01 mg ethinyl estradiol• Method failure rate 0.64%• Potentially decrease estrogen withdrawal

side effects and PMS symptoms.

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Lybrel

• 1st Continuous Oral contraceptive• 20 mcg ethinyl estradiol & 90 mcg levonorgestrel• Given daily. No hormone free break• 60% amenorrhea rate at 1 year• Increased breakthrough bleeding/spotting• Return to menses by 90 days

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Femcon Fe – (norethindrone 0.4mg and

ethinyl estradiol 35mcg chewable and ferrous fumarate tablets)

– Chewable birth control– Spearmint flavored

LoEstrin 24 Fe– (Norethindrone acetate 1mg

&Ethinyl Estradiol 20 mcg)– 24 hormone days with only 4 placebo days

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Injectable

Subdermal implants

Vaginal rings

Depot preparatio

ns

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Injectable contraceptivesInjectable contraceptives.

Progesterone only injectables

DMPA(depot- medroxy progesterone

acetate)

NET-EN( Norethandrone Enanthate)

Combined injectables

Classification

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Progesterone only injectables

Dmpa:• Dose: 150mg IM every 3 months.• MOA: suppresses ovulation• Advantage: doesn’t affect lactation, useful in

postpartum period. Can be used in the multiparae of age >35yr

NET-en:• Dose: 200mg IM every 2 months• Both DMPA & NET-EN are given in 1st 5 days of menstrual cycle. They are given deep IM in gluteus maximus

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New formulation of DMPA (Uniject)

Prefilled, singleuse syringe could be particularly

They contain a special formulation of DMPA, called DMPA-SC (104 mg).

Short needle meant for subcutaneous injection

Useful to provide DMPA in the community.

Injections by appropriately trained community health workers is safe, effective, and acceptable.

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• A woman may have a repeat injection of DMPA up to 4 weeks late. (Previous guidance said that she could have her DMPA reinjection up to 2 weeks late.)

• The guidance for reinjection of NET-EN remains at up to 2 weeks late.

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Side effects:• Disruption of normal menses • Amenorrhoea

Contraindications:• Breast cancer• Genital cancer• Undiagnosed uterine bleeding• Suspected malignancy• Lactating womenFailure rate: 0.3/HWY

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Combined injectables

• Containing long-acting progesterone with short action estrogen 25 mg DMPA + 15 mg estradiol cypionate (Cyclofem) and 50 mg NET-EN + 5 mg estrdiol valerate (Mesigyna)

• Given once a month and produce a menstruation like pattern. The trials are currently taking place in India.

MOA: • Suppression of ovulation• Alteration of cervical and endometrial secretions.C/I: • Pregnancy, °\ Thromboembolytic disorders• Cerebrovascular disease ° Coronory artery disease• Migraine ° Breast cancer• DM

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Subdermal implant

•Norplant For long term contraception. Has 6 capsules containing 35mg each of norgestrel.

•Norplant R2 – contains rods of norgestrel. Contraception is achieved in 24hrs & lasts for 5-6 yrs

Disadvantage:Surgical procedureFailure Rate: 0.1/HWY

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IMPLANON/ JadellenA flexible plastic single flexible

rod 4cm long x 2mm diameter

Contains 68mg ETONOGESTREL, an active metabolite of desogestrel

Effective for 3 years Release of etonogestrel60-70ug/day in first 5-6 weeks35-45ug/day end of year 130-40ug/day end of year 225-30ug/day end of year 3

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Implanon

Benefits• reliable long term

contraception• Improvement in

menorrhagia and dysmenorrhoea

• Beneficial effect on acne in 59%

• No adverse effects on bone mass

• No significant effect on lipids, haemostasis or liver function

Adverse side effects• Bleeding pattern altered:

Amenorrhoea 20%

Infrequent - 26%Frequent - 6%Prolonged - 12%

• Weight gain of >10% in 21% - no change from reference group

• Hormonal ‘nuisance’ effects eg breast pain, headache, libido decrease, dizziness, nausea

• Other (<2.5%) alopecia, depression,change in libido

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The Patch (OrthoEvra)

• The ORTHO EVRA patch is a thin & plastic patch that sticks to the skin. • The sticky part of the patch contains

the hormones: norelgestromin (progestin) and ethinyl estradiol (estrogen).

• Weekly for 3wks then patch free 1 week. • These hormones are absorbed continuously

through the skin and into the bloodstream.

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Vaginal ring (Nuvaring)• Etonorgestrel 120mcg +Ethinylestradiol 15mcg daily

Use for three weeks with a withdrawal week Inhibits ovulation Cycle control good Effective – Pearl index 1.8 Non-latex

• Implanted intravaginally• The progesterone is absorbed slowly through the vaginal

mucosa.• Store 2-8 degrees; if room temperature, up to 4-12• NuvaRing is 98% effective when used correctly.• Effectiveness: Overall perfect use failure rate 0.3%, typical

use failure rate 8%

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100

Nonsteroidal contraceptive drugs

Centchroman: •Non steroidal OCD developed by CDRI Lucknow contains Ormeloxifene 30mg

•Trade name ‘Saheli’

Dose: 30mg twice a week for 12 weeks followed by once in a week

MOA: •Suppression of Corpus Leuteum functions•Interferes with motility of fallopian tube hence no implantation.

Advantages: •Normal Menstruation•Complete reversibility on withdrawal

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Post conceptional methods Classification

Post conceptional methodsMenstrual Regulation

Menstrual Induction

Oral Abortifacient

Abortion

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Menstrual regulation

• No legal restriction• Aspiration of uterine content• within 6-14 days of missed period• Cervical dilatation needed in nullipara• Early complications : Bleeding, Uterine

perforation and trauma.• Late complications : Tendency to abortion or

premature births, infertility, menstrual disorders, ectopic pregnancy & Rh isoimmunisation

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Menstrual induction

• Based on disturbing the normal progesteron- prostaglandin balance by IU application of 1.5mg solution or 2.5-5mg pellet of prostaglandin F 2.

• Causes sustained uterine contraction for 7 min. followed by cyclical contraction for 3- 4 hrs.

• Bleeding starts and continues for 7-8 days.

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Oral abortifacient

• Mifepristone + Misoprostol – 95% successful in terminating pregnancies upto 9 weeks.

• Commonly used regimen • Mifepristone 200mg oral on day 1 followed by Misoprostol 800mcg vaginally immediately or 6 -

8 hrs later.

• Other regimen is • Mifepristone 600mg oral on day 1 followed by Misoprostol 400mcg orally on day 3

• Follow up visit is must within 14 days for clinical and/or USG examination

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abortion

Definition: Termination of pregnancy before the foetus becomes

viable

LEGALISATIONMedical termination of pregnancy act 19711) Conditions under which abortion is done• Medical• Eugenic• Humanitarian• Socio-economic• In failure of contraceptive device

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2) Who can perform abortion?If < 12 weeks 1 RMP having experience in OB-GYNIf > 12 weeks -20 weeks then 2 RMP opinion

3) Where can abortion be done?Place approved by civil surgeon.

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METHODS• Dilatation and Curettage: cervix is dilated

with dilators and implanted ovum is removed by doing curettage of endometrium

• Vaccum Aspiration: Implanted ovum is removed by applying suction

• PG Administration : PGE1 (misoprostol) PGF2 (carboprost),PGE2 (Dinoprost)

• Intrauterine instillation :– Intraamniotic – Hypertonic urea (40%) , saline

(20%)– Extraamniotic – Ethacrydine lactate

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Miscellaneous methods

1. Abstinence

2. Coitus Interruptus: failure rate 25/HWY

3. Safe period/rhythm period/ calendar method

Basis: ouvulation from 12th-16th day before onset of menses

Calculation: 1st day of fertile period = shortest cycle-18days

Last day of fertile period = longest cycle-10days

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Drawbacks: • Irregular cycle so difficult to predict • Only for educated and responsible couples• Programmed SexHigh Failure rate 9/HWY

Complication: Embryonic Abnormalities, Ectopic Pregnancy

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4) Natural family planning method:

Basis: same as calendar method but here the women employs self recognition of certain signs and symptoms associated with ovulation.a) Basal Body temperature methodb) Cervical mucous methodc) Symptothermic : It is based on the observation

of changes in different body signs: cervical secretions, basal body temperature and the position of the opening of the cervix.

5) Lactation

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Lactational Amenorrhea Method Algorithm

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Standard Days Method

Identifies days 8-19 of the cycle as fertile Is appropriate with menstrual cycles between 26

and 32 days long Helps a couple plan or prevent pregnancy by

knowing which days they should or should not have unprotected sex.

It is used with CycleBeads, a color-coded string of beads to help a woman: Track her cycle days Know when she is fertile Monitor her cycle length

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Terminal methods

Terminal methods

Male sterlisation

Vasectomy

No scalpel vas occlusion

Female sterlisation

Tubectomy

Laparoscopic occlusion

Tubal inserts (no incision)

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vasectomyNSV

115

Failure Rate: 0.15/HWY (due to mistaken identification of vas)

COMPLICATIONS:• Operative• Sperm granules• Spontaneous recanalisation• Autoimmune response• Psychological response

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No scalpel vas occlusion

METHODS• Elastomer plugs: Gets hardened and plugs the

vas

• SHUG: preformed silicon rubber plug is inserted.

• RISUG: Reversible Inhibition of Sperm Under Guidance

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Tubectomy

Failure rate: 0.5/HWY

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Approaches to the fallopian tubes, surgical procedures, timing of procedure,and related occlusion techniques

119

Tubal inserts (no incision)

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1.New Male Pill

• The pill contains desogestrel as well as testosterone.

Blocks the production of sperm while maintaining male characteristics and sex drive.

• It must be taken daily. • 100% effective and completely reversible in

preliminary clinical trials . • In clinical trials, all of the participants’ sperm

counts dropped to zero, which means that the male pill would be more effective than the condom and even the female pill.

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2. CatSper Blocker

• Sperm rely on calcium ions in sperm-

tail for mobility and fertilization.

• Humans -ion-channel gene -CatSper.

• Blocking CatSper action - effective form of birth

control.

• Men or women could take this potential CatSper

“blocker” because it could be made to act ”wherever

sperm are present.”

• Active only in fully developed sperm, which means

blocking or boosting its action could have few or no

side effects.

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3. Spray On -Contraceptive

• Australian biotech company Acrux has come up

with a world first — a contraceptive spray for women.

• Metered Dose Transdermal System (MDTS) to administer a pre-set dose of the Nestorone to the skin (forearm) every 14 days.

• The fast-drying spray gradually absorbed into the bloodstream.

• Suitable for

• Breastfeeding mothers

• Who cannot tolerate contraceptive pills with oestrogens.

• Leaves no visible residue & less irritation than patches.

• Because it does not have to be taken at the same time every day, it will suit women who often forget to take the Pill.

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4. Adjudin “The male Patch”

Adjudin (2,4-dichlorobenzyl- 1H-indazole-3-carbohydrazide) is non-hormonal male contraceptive drug, which acts by blocking the maturation of sperm in the testes, but without affecting testosterone production.• Normal spermatogenesis returned in 95% within

210 days after the drug had been discontinued. • The oral dose effective for contraception is so

high that there have been side effects in the muscles and liver, therefore the drug is being manufactured as implant or patch for males.

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5. Contraction Inhibitor Pill “Dry Orgasm”

• 2 different types of smooth muscle in vasa deferentia

• longitudinal muscle fibers and • circular muscle fibers. • When segments of vasa deferentia were exposed

to phenoxybenzamine or thioridazine , the longitudinal smooth muscle fibers did not contract. The circular smooth muscles did, causes, clamping the vas shut.

• Thioridizine’s side effects were so extreme(hives, difficult breathing;,swelling of face) that the manufacturer discontinued it in 2005, the common side effects of phenoxybenzamine are dizziness , fast heartbeat & stuffy nose.

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6. Anti-Fertility Vaccines

• Contraceptive vaccine either target Gamete production (GRH, FSH and LH) Gamete function (ZP) Gamete outcome (hCG).

• CVs targeting gamete function are better choices but induce oophoritis affecting sex steroids.

• Antisperm antibody-mediated immunoinfertility provides a naturally occurring model to indicate how an antisperm vaccine will work in humans.

• The hCG vaccine is the first vaccine to undergo clinical trials in humans. Both the efficacy and the lack of immunotoxicity have been reasonably well demonstrated for this vaccine.

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7. R.I.S.U.G• Reversible Inhibition of Sperm Under Guidance

(RISUG), developed at IIT Kharagpur in India by Dr. Sujoy K Guha.

• It is currently undergoing clinical trials in India. • RISUG is a non-hormonal injectable contraceptive

composed of SMA (styrene maleic anhydride) mixed with DMSO (solvent dimethylsulfoxide).

• Partially blocks the vasa deferentia and destructs the sperm

• The differential charge from the gel ruptures the sperm’s cell membrane, stopping the sperm before they can even start their journey to the egg.

• Reversals by multiple injection of dimethyl sulfoxide or sodium bicarbonate – and several months to reverse.

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8. Hydrothermal Male Control• Methods used include

1.Hot water applied to the scrotum2.Heat generated by ultrasound3.Artificial cryptorchidism (holding the testicles inside

the abdomen) using specialized briefs. • Raising the body temperature above 42 degrees Celsius

initiates certain processes, resulting in cells disability. It is called Heat Shock Factor (HSF).It disable sperm cells.

• Hot water bath (about 46.7 degrees Celsius)for 45 minutes daily for 3 weeks - simple wet heating - ensure up to 6 months of male infertility.

• ultrasound method - the testicles are heated with the help of ultrasound - only two procedures 48 hours - temporary infertility for up to 10 months.

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9. Biodegradable Time Releasing Contraceptive Implant

• In pipeline is a biodegradable contraceptive Implant that does not require surgical removal, consists of long-acting contraceptive capsule-type implant-CaproF.

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10. SILCS Diaphragm

• The SILCS diaphragm is a silicone barrier contraceptive device .

• Its dome is filled with BufferGel that acts both as a spermicide and microbicide that not only immobilizes the sperms but also kills them and fights infections.

• It avoids the need for many sizes and a pelvic exam for a correct fit; it is designed as a “one size fits most” device.

• The new device is being evaluated for comfort and ease-of-use in studies, underway in the Dominican Republic, South Africa, Thailand, and the United States.

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11. Injectable silicone plugs • Often used by men in China as a potential

alternative to vasectomy. • There are two tested types of injected plugs:

– Medical-grade polyurethane (MPU) – Medical-grade silicone rubber (MSR).

• The polymer (special ingredient) is injected directly into the vasa deferentia, Once injected, the polymer solidifies in place, forming a flexible plug.

• The procedure takes less than 30 minutes under local anesthesia.

• It is easier to reverse. It takes 2 to 4 years after the reversal procedure.

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12.Essure

• The Essure procedure involves placing a small

& flexible device called a Micro- insert into each fallopian tubes.• The Micro- inserts are made from materials that

have been well studied and used successfully in the heart and other parts of the human body for many years.

• Once the Micro-inserts are in place, body tissue grows into the Micro- inserts, blocking the fallopian tubes.

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References

• Contraceptive Updates, Reference Manual for Doctors 2009, by MOHFW & UNFPA,India.

• WHO - Medical eligibility criteria for contraceptive use – 4th ed 2009.

• WHO, Family Planning A GLOBAL HANDBOOK FOR PROVIDERS Update 2011

• “Guidelines for administration of emergency contraceptive pills by medical officers,” Research Studies and Standard Division, Department of Family Welfare, Government of India, June 2009.

• The essentials of Contraceptive Technology, a handbook for clinic staff, John Hopkins Population Information Program, 2010

• Projestin Only Injectables: Fact Sheet. UNFPA India, 2004• Guidelines for IUDs for medical officers, research studies and

standard division, Department of Family Welfare, Government of India - June 2007

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References contd…• Westhoff C, Heartwell S, Edwards S. Initiation of Oral Contraceptives

Using a Quick Start Compared With a Conventional Start: A Randomized Controlled TrialObstet Gynecol. 2007 Jun;109(6):1270-1276.

• Jick SS et al. Risk of non fatal VTE in women using a contraceptive transdermal patch and oral contraceptives containing 35 mcg EE and norgestimate. Contraception 2006;73(3):223-8.

• Sheng J et al. The LNG-IUS study on adenomyosis: a 3–year follow-up study on the efficacy and side effects of the use of levonorgestrel intrauterine system for the treatment of dysmenorrhea associated with adenomyosis. Contraception. 2009 Mar;79(3):189-93.

• Grimes DA et al. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007 Jun;75(6 Suppl):S55-9.

• Lethaby AE et al. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2005 Oct 19;(4)

• K.Park, Text book of preventive and social medicine,contraceptive methods pp.457-474,21st edition,Bhanot publication,Jabalpur, India.

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• Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J. Stewart F, et al Contraceptive Technology: 17th Revised Edition. New York. NY: Ardent Media, 1998.

• Jick SS, Jick H. The contraceptive patch in relation to ischaemic stroke and acute myocardial infarction. Pharmacotherapy, 2007, 27:218-220.

• Elkind-Hirsch KE, Darensbourg C, Ogden B et al. Contraceptive vaginal ring use for women has less adverse metabolic effects than an oral contraceptive. Contraception, 2007, 76:348-356.

• World Health Organization. Emergency Contraception. Fact Sheet No. 244, October 2005. Available at: http://who.int/mediacent/factsheets/fs244/en/print.html

References contd…

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• Allen RH, Goldberg AB, Grimes DA. Expanding access to intrauterine contraception. American Journal of Obstetrics and Gynecology 2009;201(5):456-61.

• Grimes DA, Lopez LM, Schulz KF, Immediate post-partum insertion of intrauterine devices Review, published in The Cochrane Library2010, Issue 5.

• Rajesh K.Naz, Satish K.Gupta, Jagdish C.Gupta, Recent advances in contraceptive vaccine development: a mini-review Human Reproduction 2005;vol.20,(12): 3271–3283.

• Amobi, NI, J Guillebaud, AV Kaisary, E Turner and IC Smith (2002) “Discrimination by SZL49 between contractions evoked by noradrenaline in longitudinal and circular muscle of human vas deferens.” British Journal of Pharmacology 136(1):127-35.

• http://www.who.int/reproductionhealth/publications/family_planning/• http://www.pillwatch.com/info/male-contraception-what-to-choose.html• http://www.smashinglists.com/10-advanced-methods-of-birth-control-in-

pipeline/• http://www.fsrh.org/admin/uploads/

630_NuvaringProductReview240309.pdf

References contd…