Dr rabi the estrogen free pill

The option of the Estrogen free pill.

Dr. Rabi Narayan Satapathy

Asst. Professor

Dept. of Ob. & Gynae.

SCB Medical College, CuttackMob. 09861281510

Combined Hormonal Contraceptives

Concerns & Contraindications

WHO Medical Eligibility Category 4 Health risk increases unacceptably if used Breast feeding & less than 6 weeks

postpartum Hypertension BP > 169/100 mm Hg or with

vascular disease Migraine with focal neurological symptoms Diabetes with vascular complications or > 20

yrs Past or present DVT or pulmonary embolism Complicated valvular diseaseIMAP, IPPF Bulletin, 36(5):1, 2001

Combined Hormonal ContraceptivesConcerns & Contraindications

WHO Medical Eligibility Category 4 Health risk increases unacceptably if used Acute liver disease or malignant liver

tumor Breast cancer in past 5 years (Only Category 4 contraindication of

POPs) Smoking >15 cigarettes/day at age >

35 yrs Severe decompensated cirrhosis Benign liver tumor (Category 4 for

COCs)IMAP, IPPF Bulletin, 36(5):1, 2001

Combined Hormonal Contraceptives Implications for Breast Feeding

Combined hormones definitely affect breast milk Decreased milk volume & change in milk

composition with decreased mineral content Contradictory reports on slower infant weight

gain Blackburn et al, Pop Rep, A(9):5, 2000 Breastfeeding & less than 6 weeks postpartum

is a Category 4 condition for COCs & CICs WHO Medical Eligibility Category 4 - Health

risk increases unacceptably if contraceptive is used

IMAP, IPPF Bulletin, 36(5):1, 2001

Progestogen - Only ContraceptivesBouquet of Choices

Progestogen – only pills (POP) LNG, desogestrel,norethindrone &

lynestrenol Failure rates 2-8% but under 1% during

lactation Progestogen – only injectables Depot MPA & norethisterone enanthate Failure rates 0.1-0.6% in first 12 months Progestogen – only implants LNG (Norplant) & etonorgestrel

(Implanon) Failure rates under 0.2% in first 12

months IMAP, IPPF Med Bull, 36(5):1, 2002

Progestogen - Only PillsEfficacy, Acceptability & Safety

Comparison of desogestrel 75 ug/day & LNG 30 ug/day

Multicentric randomised study of 989 subjects for 13 consecutive treatment cycles

DG users had higher incidence of amenorrhoea & infrequent bleeding with tendency to bleed less

Pearl Index 0.14 with DG & 1.17 with LNG

DG has superior efficacy with similar acceptability

Coll Study Group, Eur J Cont Rep Health Care, 3:169, 1998

Progestogen - Only PillsEffects on Lactation

Comparison of desogestrel 75 ug/day with IUCD use during lactation in 83 subjects

Evaluation of quantity & constitution of milk

Follow up of children up to 2.5 years No change in amount or constitution of

milk No affection of growth & development Safe and effective contraceptive for

lactating women

Bjaradottir et al, Br J Obs Gyn, 108(11):1174, 2001

Progestogen - Only PillsEffects on Lactation

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Growth of the newbornsGrowth of the newborns

BjaradottirBjaradottir et al, Br J et al, Br J ObsObs GynGyn, 108(11):1174, 2001, 108(11):1174, 2001

60

70

80

Length (cm)

0 1 4

Treatment periods

10

5

6

7

8

9

Weight (kg)

0 1 4 7Treatment periods

35

40

45

50Biparietal head circumference (cm)

0 1 4 7Treatment periods

IUD

Cerazette

7

Progestogen - Only PillsComparative Contraceptive Performance

Use of POPs (117), progesterone rings (187), Norplant (120) & CuT380A (122) during lactation

Initiation on day 56 postpartum All equally effective with pregnancy rates <

1% Normal breast feeding & infant growth Bleeding in first month in 50% – For over 10

days from 0% with POPs to 7% with Norplant Lactational amenorrhoea 4-5 months longer

with progestogen – only methodsDiaz et al, IPPF Med Bull, 32(2):1, 1998

Progestogen - Only PillsPerception of Traditional POPs

Concerns & disadvantages with LNG 30 ug

Less effective than COCs - Inconsistent anovulation

Reliance on cervical effect for contraception

Slight increase in risk of ectopic pregnancy

Unpredictable bleeding patterns causes discontinuation

Dose related androgenic effects on carbohydrate metabolism, serum lipoprotiens & skin

Promising development - Desogestrel 75 ug

Organon, Cerazette Sc Brochure, 1999

Progestogen - Only Pills Ovulation Inhibition

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Follicular rupture and Follicular rupture and maximum progesterone concentrationmaximum progesterone concentration

% of all cycles Desogestrel

(N=59)

LNG 30 ug

(N=57)

Follicular rupture + P > 30 nmol/l 1.7% 28%

Follicular rupture + P = 10-30 nmol/l 1.7% 3.5%

Follicular rupture + P < 10 nmol/l 1.7% 1.7%

Rice et al, Hum Rice et al, Hum ReprodReprod, 14:982, 1999, 14:982, 1999

P= Progesterone concentration

Progestogen - Only PillsOvulation Inhibition

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Maximum progesterone concentrationMaximum progesterone concentration

Desogestrel 75 ug

treatment period

LNG 30ug

treatment period

Progesterone 7(N=30)

12(N=29)

7(N=29)

12(N=28)

< 10 nmol/l 97% 97% 34% 50%

10-30 nmol/l 3% 0% 28% 11%

> 30 nmol/l 0%* 3%* 38% 39%

Rice et al, Hum Rice et al, Hum ReprodReprod, 14:982, 1999, 14:982, 1999

* p < 0.001 compared to levonorgestrel group

Progestogen - Only PillsContraceptive Efficacy

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Excluding exposure during breastExcluding exposure during breast--feedingfeeding

Treatment Woman-years Pregnancies Pearl Index

Desogestrel 600 1 0.17

LNG 30 ug 213 3* 1.41

* including one ectopic pregnancy

CollColl Study Study GrpGrp, , EurEur J J ContraceptContracept Rep Health Care, 3:169, 1998Rep Health Care, 3:169, 1998

Progestogen - Only PillsBleeding Patterns

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Definitions over a 90 days reference periodDefinitions over a 90 days reference period

• Amenorrhea no bleeding• Infrequent B/S 1 or 2 B/S episodes• Frequent B/S 6 or more B/S episodes

• ProlongedB/S B/S episode > 14 days

B/S = bleeding/spotting

BelseyBelsey et al, Contraception, 34:253, 1986et al, Contraception, 34:253, 1986.


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Reference periods in efficacy studyReference periods in efficacy study

Treatment days

reference period 1 1 - 90

29 - 118 shifted reference period





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Shifted reference period Shifted reference period –– 29 to 118 days29 to 118 days

0

10

20

30

40

50

60

70

80

amenorrhea 1-2 B/Sepisodes

3-5 B/Sepisodes

6 or moreB/S episodes

prolonged

Cerazettestarters/switchers

30 µg LNGstarters/switchers

%

CollColl Study Study GrpGrp, , EurEur J J ContraceptContracept Rep Health Care, 3:169, 1998Rep Health Care, 3:169, 1998.


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Reference period 4 Reference period 4 –– 271 to 360 days271 to 360 days

0

10

20

30

40

50

60

70

80

amenorrhea 1-2 B/Sepisodes

3-5 B/Sepisodes

6 or moreB/S episodes

prolonged

Cerazettestarters/switchers

30 µg LNGstarters/switchers

%

CollColl Study Study GrpGrp, , EurEur J J ContraceptContracept Rep Health Care, 3:169, 1998Rep Health Care, 3:169, 1998

Progestogen - Only PillsNuances of Dose Scheduling

Traditional POPs have peak effect with in 4 hrs lasting up to just under 24 hrs

Contraceptive protection lost if delay > 3 hrs in taking the next tablet

Desogestrel 75 ug suppresses the HPO axis

Dosage at regular 24 hr intervals Delay of up to 12 hrs does not affect

efficacy & tablet not considered missed if taken with that time offering a greater margin of error

Organon, Cerazette Sc Brochure, 1999

Health & Medicine

Dr rabi the estrogen free pill