Hormonal contraceptives

Oral Contraceptive Pills

Dr. Woothvasita Mondal

MBBS, MS

SR, Dept of OBG, IQCMC

What is OCP?

Oral Contraceptive Pills.• Pills which is taken orally and it

prevents pregnancy.

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Types of OCPHormonal

• COC (Combined oral contraceptives)

• POP (Progesterone Only Pills)

Non-Hormonal• Centchroman

(Saheli)

What’s in “The Pill”

• 15-50 micrograms estrogen (ethinyl estradiol is a synthetic form of estrogen, which is used most commonly)

• Varying amounts of progestagen component (commonly levonorgestrel)

• Types of Regimens – 21-day or 28-day pack

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MOA

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Combined mode of action of estrogen and

progestin• Prevents ovulation• Thickens mucous in cervix• Thins endometrium

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Ovulation

Mechanism of anovulation

• Inhibit ovulation: Both hormones acts synergistically on the HPO axis.

• The release of GnRH from the hypothalamus is prevented through a negative feedback mechanism.

Mechanism of anovulation

• So, no peak release of FSH & LH from the anterior pituitary occurs.

• So, follicular growth is either not initiated or if initiated –recruitment doesn’t occur.

• Resulting Anovulation.

The 21 day pack

• The first seven pills in a packet inhibit ovulation.

• The remaining 14 pills maintain anovulation.

Estrogen• Primary female sex hormone• Roles of estrogen:

–To develop secondary female sex characteristics

–Thicken the endometrium–Regulate menstrual cycle

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Combined Hormonal contraceptives

Combination of estrogen & progesterone.

Commonly used estrogens are:• Ethinyl-estradiol• Mestranol (3 methyl ether of Ethinyl-estradiol)

Naturally occurring estrogens

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Estradiol

Estrone

Estriol

Synthetic Estrogens

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Functions of estrogen in OCP

1. Improves the efficacy over progesterone only pills.

2. Inhibits FSH rise & prevents follicular growth.

3. It provides better cycle control than progesterone only pills

4. It prevents Break through bleeding.

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Progesterone

• Produced by– Adrenal glands– Gonads– Brain– Placenta (only during pregnancy)

Primary Effect- prepares uterus for implantation by the proliferation of endometrium; prepares body for pregnancy

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Progesterone

• Natural progesterone- destroyed by digestive system when consumed orally

ALL oral contraceptives contain progestin, synthetic form of progesterone

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Different progestogens can be classified

According to their steroid structure

1. -PREGNANES (derived from the progesterone molecule),

2. -ESTRANES (derivatives of testosterone), and

3. -GONANES

Timing of their introduction into the market.

1st, Generation

2nd, Generation

3rd, Generation

4th, Generation

Progestins

GONANES

Generations

1st <1973 Norethisterone

2nd 1973-1989 LNG, Norgestimate

3rd 1990-2000 Desogestrel, Gestodene

4th > 2000 Drospirenone

Progestins

Combined Hormonal contraceptives

Combination of estrogen & progesterone.

Commonly used Progestins are:• Levonorgestrel• Norethisterone• Desogestrel• Drospirenone.

Role of progestins in COC

• Primarily inhibits LH surge & thereby ovulation.

• Counteract the adverse effects of estrogen on the endometrium (Hyperplasia)

• Thickens cervical mucosa & thereby sperm penetration difficult.

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Advantages of 3rd generations of

progestins• Lipid friendly progestogens.

• to minimize androgenic side effects such as acne, hirsutism, nausea, and

lipid changes while

• increasing progestational effects

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Advantages of 4th generations of

progestins• Drospirenone.• Dienogest, • Nomegestrol

• All three progestogens have antiandrogenic activity;

• drospirenone has antimineralocorticoid activity.

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Dosage of EE in COCs

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Commonly available COCs in the market

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Brand Name Progestin Estrogen Pack

Mala-D ,Mala-N

Levonorgestrel 150 mcg

Ethinyl Estradiol 30 mcg

21+7 tab pack

Loette, Femilon

Desogestrel 150mcg

Ethinyl Estradiol 20 mcg

21 tab pack

Yasmin, Dronis

Drospirenone 3 mg

Ethinyl Estradiol 30 mcg

21 tab pack

What to do before prescribing COC

• A proper history and general examination is important before prescribe.

• H/O headache, migraine,• H/O amenorrhoea• Family H/O Breast cancer

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What to do before prescribing COC

• Breast examination for any nodule• Weight and BP• Pelvic examination to rule out any

cervical pathology• Pregnancy must be excluded• A cervical smear should be taken

before.

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Instruction for pill use

New user• New users should normally start

their pill pack on Day 1 of their menstrual cycle.

• 1 tab daily preferably at the same time (e.g. bed time)

• Continue upto 21 days and then a 7 days gap.

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Instruction for pill use

New user• During this 7 days period there will be withdrawl bleeding.

• Then start new pack on the 8th day (irrespective of the withdrawl bleeding)

• 3 wks & 1 wk off• Pill which contains 28 tabs have 7

placebo tablets, so no need to give a gap.

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What if she did not started on Day1

• She can start upto day 5.• But has to take additional

precaution (condom) for next 7 days.

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Special situations

• After abortion: the day after abortion

• After delivery: • If non-lactating after 6 wk (WHO) ?• Lactating: no COC.

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Follow up

• Check the patient after 3 months, 6 month and then once every yearly.

• More frequent check if >35 yr.

• Ask for any adverse effects• Examine breasts, weight, BP.• Pelvic examination if required.

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Miss pill

• If forgets to take one pill (late upto 24 hr).

• She should take the missed pill at once and continue the rest as schedule.

• There is nothing to worry.

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If one pill has been missed (more than 24 hours and up to 48 hours late)

Next pill on usual time

Keep taking active pills as

usual

Take a pill as soon you

remember

???Doctor, I missed 2 pills in the middle

of my pack. What should I do?

If two pills have been missed (more than 48 hours late)

• Return to next day active pill• Avoid sex or use extra method next 7

days.• EC if already had sex.

If pills are missed in week

1 (Day 1-7)

• Finish the active pills• Start a new pack from day 22 with no

PFI• EC if already had sex• Extra method next 7 days

If pills are missed in week

3(Day 15-21)

If two pills have been missed in 2nd wk (Day 8-14)

• No indication for EC if the pills in the preceding 7 days have been taken consistently and correctly

• Take 2 tab as soon remembers & continue the rest as usual.

• Condoms should be used or sex avoided until 7 consecutive active pills have been taken.

Any time >2 miss pills

• The most recent missed pill should be taken as soon as possible, leave any earlier missed pills.

• Condoms should be used or sex avoided until 7 consecutive active pills have been taken.

• EC according to the situation• Start a new pack from day 22 with

no PFI

Missed inactive pills

• Discard the missed pill• Nothing to worry• Continue the rest as usual.

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Efficacy

• As a contraceptive.• Failure rates are 0.1 per 100

women year.

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Contra-indications

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Contra-indicationsWHO MEC Cat4

• Circulatory disease (present or Past)

• Liver disease • Others

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WHO MEC Cat4Circulatory disease (present

or Past)

• Arterial/venous thrombosis• Severe Htn• H/O stroke• Heart disease (valvular,

ischaemic)• Diabetes with vascular

involvement• Migraine with aura

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WHO MEC Cat4Liver disease

• Active liver disease • Liver adenoma• Liver carcinoma

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WHO MEC Cat4Others

• Pregnancy• Breast feeding (post partum upto 6

wk)• Major surgery or prolonged

immobilization• Estrogen dependent cancers

(Breast cancer)

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WHO MEC Cat3

• Benign liver tumour• Breast feeding (post partum from

6 wk to 6 month)• Heavy smoker (>20 cig/day)• Past H/O breast cancer• Hyperlipidaemia• Unexplained vaginal bleeding

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WHO MEC Cat2

• Age ≥40 yr• Smoker <35yr• H/O jaundice• Mild Htn• Gallbladder disease• Diabetes• Sickle cell ds• Headache• Cancer cervix or CIN 50

Ideal candidates

• Age: menarche to 40 yr• Newly married/ frequent sexual

activity• Non obese• Normotensive• Can take pills regularly without

missing.• No contraindications.

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Drug interaction

Reduces the efficacy of

• Aspirin• Oral anticoagulants• Oral hypoglycaemics

Increases the efficacy of

• Beta blockers• Cortico-steroids• Diazepam

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Additional contraceptives if:

• Using broad spectrum antibiotics (ampicillin, tetracycline)

• Using enzyme inducing drugs (Burbiturates, Anti-epileptics, Nevirapine).

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Minor adverse effects of COCs

• Nausea, vomiting• Mastalgia• Weight gain• Cholasma & acne• Menstrual abnormalities (Break-

through bleed, Hypomenorrhoea, Menorrhagia, Post pill amenorrhoea)

• Loss of libido• White vaginal discharge (leukorrhoea)

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Major adverse effects

• Hypertension• Depression• Vascular complications (venous/

arterial thrombo-embolism)• Cholestatic jaundice

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Caution if develop

• Severe migraine• Visual or speech disturbance• Sudden chest pain• Unexplained fainting attack• Severe cramps & pain in legs• Excessive weight gain• Severe depression

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COC & neoplasia

Protects against:• Endometrial Ca• Epithelial ovarian Ca• Colorectal Ca

No direct relation with Breast cancer & cervical cancer with low dose estrogen COCs.

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Advantages

• Highly effective• Good cycle control• Convenient to use• Not intercourse related • Reversible• Additional non-contraceptive

benefits.

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Non-contraceptive benefits.

Improvement of menstrual abnormality:

• Cycle regulation• ↓Dysmenorrhoea• ↓Menorrhagia• ↓ PMS• ↓ Mittelsmerz’s syndrome• Protect against anemia• In patients with PCOS. 59

Non-contraceptive benefits Protects

against • PID (thickens Cervical mucosa)• Ectopic pregnancy• Endometriosis• Fibroid uterus• Hirsutism & acne• Functional ovarian cyst• Benign breast disorder• Osteopenia

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Non-contraceptive benefits Protects against Cancers

• Endometrial Ca• Epithelial ovarian Ca• Colorectal Ca

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Dis-advantages

• Requires education & motivation• Requires initial check-up & follow-

up• Risk of drug interaction & failure• Side effects may develop• Many contra-indications are there.• Miss pill problems.

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Tri-phasic pill

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Triphasic pills

• Estrogen & progesterone dosage vary over the course of the cycle.

• Minimum dosage in the 1st half of the cycle for contraceptive purpose.

• Maximum dosage given in later part of cycle to prevent Break through bleeding.

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Triphasic pillsSharing-AG,

Triquilar

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1st 6 tablets 50 mcg LNG 30 mcg EE

Next 5 tablets 75 mcg LNG 40 mcg EE

Last 10 tab 125 mcg LNG 30 mcg EE

Triphasic pills-Advantage

• It minimizes undesirable side effects of COCs on lipid profile

• Without compromising the contraceptive efficacy.

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???What if I vomit or have

diarrhoea?

If you vomit • Take another pill as soon as possible. • If you do not vomit this second pill and it

is taken on the same day, then nothing to worry.

within 2-3 hours of

taking a pill

• Then follow the same as missing pills .If you

continue to vomit

Diarrhoea

• No affect on the absorption of the pill.Mild

diarrhoea

• consider this as the same as missing pills.Severe

diarrhoea

What happens if I don't have a

withdrawal bleed between packs?

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No withdrawal bleed between packs

• It is quite common for there to be no bleeding between pill packs.

• You are not likely to be pregnant if you have taken the pill correctly and have not vomited or taken any medicines that can interfere with the pill.

• Start the next pack after the usual seven-day break and continue to take pill as usual.

See your doctor or nurse if:

1. You don't have any bleeding after the next pack (two packs in total); or

2. You have not taken the pill correctly; or3. You have any reason to think that you may be

pregnant.

A pregnancy test may be advised, considering the circumstances.

Doctor, I am Bleeding whilst on

the pill & I am Worried.

???

Bleeding whilst on the pill (breakthrough bleeding)

• During the first few months, while your body is adjusting to the pill, you may have some vaginal bleeding in addition to the usual bleeding between packs.

• This is not serious but more of a nuisance. It may vary from spotting to a heavier loss like a light period.

• Do not stop taking your pill. This usually settles after the first 2-3 months.

Can I delay or skip a withdrawal

bleed (period)?

???

Can I delay or skip a withdrawal bleed (period)?

• There are times when it is useful not to have vaginal bleeding, for example, during exams or holidays or any ceremony.

• Bicycling/Tricycling may be done- using monophasic pills (most commonly used), you can go straight into your next pack without a break. Have the usual seven-day break at the end of the second /third packet.

Thank You