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HORMONAL CONTRACEPTION & NEWER CONTRACEPTIVES BY DR SHASHWAT JANI
1. Hormonal
Contraceptives
Dr Shashwat K. Jani.
M.S. ( Gynec )
Diploma in Endoscopy.
Assistant Professor, Smt. N.H.L. Medical College.
Sheth V. S. General Hospital, Ahmedabad.
( M ) : 99099 44160.
E- mail : drshashwatjani@gmail.com
2. Introduction
World’s population expected to reach 9 billion by 2050.
India accounts for 18% of World’s population… !!!
Annually, 529,000 maternal deaths & 50 million
morbidity.
In India, contraceptive prevalence is 48.3% .
21% of all pregnancies resulting live births are
unplanned….!!!
If unmet need for contraception was met, we can avoid
52 million unwanted pregnancies
25-50% of maternal deaths
( Hindin MJ, Lancet. 2007;370:1297-8 )
Dr Shashwat Jani. 9909944160 210/13/2015
7. 1st Clinical trials of COC were
described by John Charles Rock &
Goodwin Pincus with approval of
marketing in USA in 1960.
Within 5 years it was used by 30
millions women all over the world.
At the moment , COC is used by over
100 million women worldwide.
Dr Shashwat Jani. 9909944160 710/13/2015
8. Combined Oral Contraceptives ( COC )
Commonly known as the “ Pill “
Widely Accepted & Most Effective
Reversible method of Fertility Control.
In 1951, India was the 1st country in
world to introduce COC in National
programme of Family Planning.
8Dr Shashwat Jani. 990994416010/13/2015
9. COC : Estrogen + Progestogen
Estrogen :
2 types : - Ethinyl Estradiol ( EE )
- Mestranol ( Not used )
Dr Shashwat Jani. 9909944160 910/13/2015
14. 1) Monophasic
Contains Estrogen & Progesterone in same
amount in Each pill .
Divided in 2 subgroups :
- Low dose pills : EE 30 – 35 microgm
- Very low dose pills : EE 15 – 25 microgm.
Mala - N
• dl – NGL 0.15 mg
• EE 0.03 mg
Mala - D
• l – NGL 0.15 mg
• EE 0.03 mg
14Dr Shashwat Jani. 990994416010/13/2015
15. 2 ) Multiphasic
Contains low or variable amounts of E and P in 2
( biphasic ) or 3 ( triphasic ) phases of cycles.
Biphasic : constant EE – 35 microgm
progestogens : low in first 10 days
higher in next 11 days .
NOT POPULAR – MORE FAILURE RATE .
NOT AVAILABLE IN INDIA …
15Dr Shashwat Jani. 990994416010/13/2015
16. Triphasic :
Triquilar –
- 0.03 EE +0.5mg l-norgestrel (1 - 6)
- 0.03 EE +0.75mg l-norgestrel (7-11)
- 0.03 EE +0.125mg l-norgestrel (12 - 21)
Total monthly intake – 0.68mg EE +1.92mg progesterone
• Adv. – high efficacy rates
- few side effects
- less break through bleeding
- does not affect s.cholesterol & LIPIDS
• Disadv. – high pregnancy rates if errors in pill intake .
16Dr Shashwat Jani. 990994416010/13/2015
17. Mechanism of action:
1 ) Inhibition of Ovulation :
both hormones act on Hypothalamo pituitary
axis , suppress release of FSH & LH from Ant.
Pituitary.
E – inhibits FSH.
P – inhibits preovulatory LH Surge , less effect
on FSH.
17Dr Shashwat Jani. 990994416010/13/2015
18. 2 ) Endometrial Hyperplasia :
stromal oedema , decidual reaction &
regression of glands making endometrium
nonreceptive to embryo.
3 ) Cervical mucus :
thick , viscid , scanty .
impaired sperm transport & penetration.
4 ) May affect tubal motility & alter tubal
transport.
18Dr Shashwat Jani. 990994416010/13/2015
19. Selection of the patient
Detail history ( headache , migraine , etc…)
Thorough general examination
( Breast , blood pressure… )
Pelvic examination to exclude cervical
pathology.
Cervical cytology
Rule out any other contraindications.
Dr Shashwat Jani. 9909944160 1910/13/2015
20. Checklist for Prescribing COC…
Last menstrual period, rule out pregnancy
Less than 6 months postpartum & lactating?
Age, Cigarette smoking, h/o migraine
Known case of diabetes or hypertension
History of stroke, MI or thrombosis
h/o jaundice/ liver disease
h/o breast/ genital tract malignancies
h/o drug intake: Antitubercular, antiepileptic
Dr Shashwat Jani. 9909944160 2010/13/2015
21. Administration
New User :
- 1st day of Cycle .
- Daily 1 tab. Preferably at night for consecutive 21 days.
- Continued for 21 days and then 7 days break ( with
iron tablets ) .
- Next pack of Pill should be started on 8th day ,
IRRESPECTIVE OF BLEEDING ( same day of the week , pill
finished ).
- Simple Regimen of “ 3 WEEKS ON & 1 WEEK OFF “
- No break between packs.
Can start pill up to 5 days of bleeding with extra
precaution with condom for next 7 days.
21Dr Shashwat Jani. 990994416010/13/2015
22. Missed Tablets :
1 missed – Take 2 tablets next day .
2 or 3 missed – Take 2 tablets on two consecutive
days and continue the rest of the pack.
+Another Contraceptive for 1 week.
Dr Shashwat Jani. 9909944160 2210/13/2015
23. Missed Pill Regime (WHO)
Women who frequently miss pills should consider alternate10/13/2015 23Dr Shashwat Jani. 9909944160
24. • Lactating Women – Progestogen only pills /
Combined pills after 6 months
• Non Lactating Women – Combined oral pills
after 3 to 6 weeks or after menstruation
• 1st / 2nd Trimester abortion – during first 7
days.
• Amenorrhea : At any time after excluding
pregnancy + barrier method for 7 days.
24Dr Shashwat Jani. 990994416010/13/2015
25. Extended Use of COC…
(Seasonale)
Available since 2003
150µg of LNG + 30µg of EE
Only Active Pills taken continuously for 84 days,
then break for 7 days.
Fewer periods (4 in a year)
Pearl index- 0.78
Breakthrough bleeding/ spotting – First few
cycles
10/13/2015 25Dr Shashwat Jani. 9909944160
26. Follow up …
Examined after 3 months , then after
6 months and then yearly .
Ask for any symptoms…
Examination for breast , pelvis, BP & weight &
cervical cytology.
Dr Shashwat Jani. 9909944160 2610/13/2015
27. Effectiveness…
Failure rate : 0.1%
Failure rate are mainly
due to missed pills.
27Dr Shashwat Jani. 990994416010/13/2015
28. How long can be continued …???
In properly selected patient without
any risk factor , benefits are more ,
and so can be continued up to age of
50 with careful monitoring. Offers
dual advantage of Contraception and
HRT.
For spacing of birth : 3 – 5 years.
28Dr Shashwat Jani. 990994416010/13/2015
29. Advantages…
• Prevention of pregnancy
India - MMR 1per 57 i.e. 400 in 1,00,000
2/5th of these deaths can be prevented by use
of OCs
• Cyclical Stabilisation
Great social advantage.
Withdrawl bleeding is predictable &
postponed safely by taking more low dose pills
contineously .
29Dr Shashwat Jani. 990994416010/13/2015
30. • Cure of Menstrual Disorders
Dysmenorrhoea & Ovulation pain – By inhibiting
ovulation & production of PG .
Menorrhagia & Metrorrhagia - Norgestrel High dose oral
pills more useful.
Lessens PMT.
• Protection against Cancer
a) Endometrial cancer- Reduction by 50 %
effect persists for 15 yrs.
b) Ovarian Cancer – Reduction by 40 %
effect persists for 10 yrs.
c) Choriocarcinoma – Indirectly prevention by preventing
pregnancy.
30Dr Shashwat Jani. 990994416010/13/2015
31. • Protection against benign tumors
1) Fibrocystic and Fibroadenomatous disease
2) Ovarion Functional Cysts
1) Follicular Cyst – 50 %
2) Corpus Luteum Cyst – 80 %
3) Fibroid Uterus - Reduction by 30%
Low Dose OC’s reduce fibroid ( WHO 1996)
31Dr Shashwat Jani. 990994416010/13/2015
32. • Protection against diseases
1) Ectopic Pregnancy
2) PID
3) Anaemia and Malnutrition
4) Endometriosis
5) Acne and Hirsutism
6) DUB
7) Osteoporosis
• Simplicity and Attractiveness
• No Affection on Future fertility ( 3 months )
32Dr Shashwat Jani. 990994416010/13/2015
33. Emergency Contraception…
1) Yuzpe regimen –
0.1mg EE + 1 mg dl-Norgestrel
1st dose Within 72 Hrs of Contact
Repeated after 12 Hrs.
2) Ovral
1st dose 2 tablets within 72 hrs.
2nd dose 2 tablets after 12 hrs.
3) Overal – L
1ST dose 4 tablets within 72 hrs.
2nd dose 4 tablets after 12 hrs.
Dr Shashwat Jani. 9909944160 3310/13/2015
34. Minor Side Effects…
• Nausea, Vomiting and Lack of appetite
• Break through bleeding
• Menorrhagia and irregular bleeding
• Oligomenorrhoea and Amenorrhoea
• Breast changes – Heaviness and Tenderness
• Vaginal Discharge – Cx -erosion, dysplasia causes
leucorrhoea
• Headache and Migraine
• Chloasma
• Wt. Gain
• Psychosexual Trouble – Depression, Loss of Libido
• Others - Leg Cramps, Dimness of Vision
34Dr Shashwat Jani. 990994416010/13/2015
35. Major Side Effects…
• Cardiovascular Diseases
1) MI – Increased Risk in heavy smokers
2) Ischaemic Stroke - 1.5 times more
3) Haemorrhagic Stroke – double risk
4) Venous Thromboembolism – Risk increases
with age, recent surgery and thrombophilia
• Hypertension - In women more than 35 Yrs.
• Carcinogenecity
1) Breast Cancer
2) Cervical Cancer
35Dr Shashwat Jani. 990994416010/13/2015
36. Interaction With Drugs…
1) Barbiturates , Sulphonamides, Rifampicin
and Anticonvulsant interfere with OC’s and
failure rate increases
2) Interaction with antidiabetic drugs
3) Vit. C aggravates the effect of COC.
36Dr Shashwat Jani. 990994416010/13/2015
37. Absolute Contraindications…
(WHO Category IV)
• Migraine, with focal Neurological Symptoms
• Pregnancy and breast feeding ( 6 Months)
• Severe Hypertension
• Complicated valvular heart disease
• D.M. with vascular complications
• Active hepatitis, liver tumors
• Major Surgery
• Prolonged Immobilization .
37Dr Shashwat Jani. 990994416010/13/2015
38. Indications of Withdrawal :
Severe migraine
Visual or speech disturbances
Sudden chest pain
Unexplained fainting attack or acute vertigo
Severe leg cramps
Excessive weight gain
Severe depression
Prior to surgery ( Atleast 6 weeks )
Patient wants pregnancy …
38Dr Shashwat Jani. 990994416010/13/2015
40. MINI PILLS
Schedule
• 1st day of M.C. and a backup method for 7 days
• 6 wks after delivery – no backup method
• Missed Tablet – Backup method for 48 Hrs.
• Failure Rate - 3- 10 %
Lactating Women – 0.5 %
Advantages
Can be used above 16 yrs of age, Smokers &
obesity
Best in DM, CVS Diseases & SLE
Disadvantages
Irregular Bleeding, Acne, Mastalgia, Amenorrhoea
10/13/2015 40Dr Shashwat Jani. 9909944160
47. Advantages :
Convenient to use
Suitable for those who have faith in injection
No interference with sex
No bad Oestrogenic effect
No menstrual flow and prevents anaemia
Most suitable for lactating women
No reduction in milk volume / constitution
However should not be given before 6 wks. as
may cause greater and irregular bleeding in
the puerperium
10/13/2015 47Dr Shashwat Jani. 9909944160
48. Advantages :
• Wt. gain 1 – 3 Kg.
• Sickle cell anaemia – prevents sickling &
development of abnormal shaped RBC’s
• Reduces risk of PID
• Protection against endometrial cancer
• Suitable for myoma & endometriosis
• Prevents ovarian Cancer
10/13/2015 48Dr Shashwat Jani. 9909944160
49. Side Effects
• Irregular menses, Amenorrhoea
• Excessive bleeding in the first injection cycle
Treatment - EE 0.05 mg to 0.1 mg
Conjugated Oestrogen 1.25 – 2.5 mg
NSAID – Ibuprofen
• Wt Gain
• Headache, dizziness, bloating of abdomen
10/13/2015 49Dr Shashwat Jani. 9909944160
51. Hormone releasing IUD
Progestasert
Levonorgeastrel IUD 20 – LNG 20
T Shaped
Hormonal capsules in the vertical rod.
Maintains high local level of
progesterone and low estrogen
10/13/2015 51Dr Shashwat Jani. 9909944160
52. Progesterone IUD
38 mg of progesterone
65 mcg of Progesterone / Day
Reduces Menstrual loss
Disadvantage
Costly
1 Yr. Life
Insertion may require LA / Sedation
10/13/2015 52Dr Shashwat Jani. 9909944160
53. LNG 20 /LNG IUS 20
(MIRENA)
40 – 60 mg of LNG on stem.
Release 20 mcg / Day
Life 5 Years
Failure Rate 0.1 to 0.4 %
Difficult Insertion due to greater thickness
Advantages –
Contraception
DUB
10/13/2015 53Dr Shashwat Jani. 9909944160
55. Norplant
• 6 Silastic rod – 3.4 mm x 2.4 mm
• 36 mg LNG
• Daily release 50 – 80 mcg for 1st yr.
30 – 35 mcg over next 5 yrs.
• Life 5 Yrs.
• Insertion –
Day 1 – 7 of M.C.
Immediately after abortion
6 Wks after delivery
10/13/2015 55Dr Shashwat Jani. 9909944160
56. Technique
Arm / Forearm under the skin
Under L.A
Small incision made
6 rods inserted in fan shaped manner
Special trocar used for insertion
Effective within 24 Hrs.
Removal after 5 Yrs. under LA
10/13/2015 56Dr Shashwat Jani. 9909944160
57. Mechanism
• Suppression of Hypothalamic and pituitary
hormones and prevents ovulation
• Depresses endometrial growth
• Cervical Mucus thickening
Eligibility -
Women of all ages
Women who do not want pregnancy for several
years
Disadvantages
1) Trained person required for insertion and removal
2) Irregular bleeding
3) Infection
4) Hematoma
5) Removal may be difficult
10/13/2015 57Dr Shashwat Jani. 9909944160
58. IMPLANON
In July 2006
3 – Keto desogestrel – 67 mg.
Single rod
40 x 2 mm
Preloaded applicator
Insertion in upper arm S/c
Life 3 Years
10/13/2015 58Dr Shashwat Jani. 9909944160
59. LNG ROD / JADELLE /NOR PLANT II (1996)
• 2 Solid Silastic rod
• 44 mm x 2 mm
• 70 mg of LNG – Release 30 to 35 mcg
daily
• Life 5 Years
10/13/2015 59Dr Shashwat Jani. 9909944160
60. Contraceptive Vaginal Rings
Combined rings –
12 mcg EE + 12 mcg desogestrel
Inserted for 21 days
Removed for 7 days and reinserted
Renewed every 3 months
Levonorgestrel rings –
5 mg LNG
Daily release 20 mcg
Continuous use for three months and then replaced
Drawbacks – Expulsion during defecation
Failure rate – 3.7 %10/13/2015 60Dr Shashwat Jani. 9909944160
61. Transdermal Contraceptive Patch
Patch should used for wk. for cons. 3 wk.
& followed by 1 patch free wk
Combined – EE + Norgestimate
Hormone Release for 7 days
10/13/2015 61Dr Shashwat Jani. 9909944160
63. MALE
GOSSYPOL :
- A Chinese drug … !!!
- extract from Cotton seed.
- Oral 10 – 20 mg daily for 3 months then 20 mg
twice weekly.
- Inhibit Spermatogenesis by acting on
seminiferous tubules.
- S/E : fatigue, decrease libido, hypokalamic
paralysis.
63Dr Shashwat Jani. 990994416010/13/2015
64. Polyurethane Male Condom
• Stronger and thinner than
latex condoms
• Better heat transmission
• Can safely be used with oil-
based lubricants
• Can be used by those with
latex allergies
10/13/2015 64Dr Shashwat Jani. 9909944160
65. GnRH Analogues :
- decline in sperm density , sperm motility,
decrease in testosterone level.
- Marked loss of libido makes it unacceptable .
Add back therapy with Testosterone is given.
65Dr Shashwat Jani. 990994416010/13/2015
66. Male Hormonal Contraception
• Recent trials at Andrology Clinic,
Concord Hospital
• Depo Provera plus testosterone
implants 3 monthly.
• Very low sperm count (less than 1
million per ml) in all men on trial -
80% had no sperm.
• Few side-effects
• Similar regime using an oral
progestogen and testosterone
implants being trialed in UK
• Implants and testosterone also
being trialled.10/13/2015 66Dr Shashwat Jani. 9909944160
67. RISUG :
- “Reversible Inhibition of Sperm Under
Guidence . “
- Developed by IIT & AIIMS.
- clear polymer gel made of Styrene maleic
anhydrate ( SMA ) mixed with Dimethyl
Sulphoxide ( DMSO ) injected in to Vas
deferens partially blocks Vas , preventing
sperm from coming in to ejaculate.
- Phase I & Phase II trials cleared.
- VASALGEL is similar to it.
67Dr Shashwat Jani. 990994416010/13/2015
68. Intra Vas Device ( IVD ) – Shug :
- 2 devices inserted in to each Vas .
- Needs special surgical skill.
- wider trials needed.
68Dr Shashwat Jani. 990994416010/13/2015
69. Voegeli’s Heat Method
• A small increase in the temperature of the testes has a
large negative impact on the production of sperm
(spermatogenesis).
• Voegeli’s program for temporary sterilization is as
follows:
“A man sits in a [shallow or testes-only] bath of 116
degrees Fahrenheit for forty-five minutes daily for
three weeks.
Six months of sterility results, after which normal
fertility returns.
For longer sterility, the treatment is repeated. ”
• .
69Dr Shashwat Jani. 990994416010/13/2015
70. Artificial Cryptorchidism/ Suspensories
(a) testes in normal position;
(b) testes raised to near inguinal canal; testes held in
place with
(c) briefs with ring of soft rubber or (d) ring alone.
70Dr Shashwat Jani. 990994416010/13/2015
71. Gendarussa
• First nonhormonal male contraceptive pills.
• Developed by Indonesia.
• Active ingredient in Gendarussa disrupts an
enzyme in the sperm head, which weakens
the ability of the sperm to penetrate the
ovum.
• The effect is short term and reversible –
having no effect on male hormones.
• Still under clinical trials…
71Dr Shashwat Jani. 990994416010/13/2015
72. Nifedipine – CCB
• CCBs also partially block the calcium channels
within the cell membranes of sperm. This
affects sperm function rather than production.
• A man taking nifedipine produces a normal
amount of sperm, and the sperm appear
functional when viewed through a
microscope. But in vitro tests show that these
sperm cannot fertilize an egg.
72Dr Shashwat Jani. 990994416010/13/2015
73. Male Vaccines …
• Scientists are trying to isolate, identify, and
produce Anti sperm surface antigens which
will hinder sperm – egg without side effects.
• Will take long time…
73Dr Shashwat Jani. 990994416010/13/2015
74. Other Ongoing trials…
• Use of following as Male Contraceptives…
1 ) Neem extracts.
2 ) retinoic receptor antagonist
3 ) papaiya seed extracts
4 ) olealonic acid
74Dr Shashwat Jani. 990994416010/13/2015
75. FEMALE
Many researches are going
on for development of newer
Contraceptives for females which are
either Non Hormonal OR having low
dose of Estrogen and newer
Progestogens.
75Dr Shashwat Jani. 990994416010/13/2015
77. SILCS Diaphragm
• Cervical barrier device
• One-size-fits most
• Developed with input
from women and
men in multiple
countries
• Regulatory application
in Europe & US.
77Dr Shashwat Jani. 990994416010/13/2015
78. Centchroman ( Saheli )
• Ormeloxifene .
• research product of CDRI , Lucknow
• Non steroidal , potent anti estrogenic , weak
estrogenic.
• Prevent implantation of fertilized ovum .
• Orally 30 mg twice weekly for first 3 months
then once a week.
• Avoided in PCOD, liver , kidney disease.
78Dr Shashwat Jani. 990994416010/13/2015
79. Non contraceptive uses …
• DUB
• Endometrial Hyperplasia
• Endometriosis
• Breast cancer
• HRT
79Dr Shashwat Jani. 990994416010/13/2015
80. Combined Injectable
Contraceptives
• CYCLOFEM :
- DMPA 25 mg + Ostradiol cypionate 5 mg.
• MESIGYNA :
- NET- EN 50 mg + Oestradiol valerate 5 mg.
• Given within first 5 days of menstruation
• Next dose on same date of each month.
80Dr Shashwat Jani. 990994416010/13/2015
81. New formulation of Depo-Provera:
Depo-subQ Provera 104, for delivery with Uniject
Depo-subQ Provera 104:
New formulation for subQ injection
30% lower dose (104 mg vs. 150 mg)
Rapid onset of action
Same effectiveness, same length of protection (>3 months)
Approved by USFDA (2005) and UK
Potential for home- and self-injection
Available for roll-out in 2011; Acceptability studies to begin in
mid-2010
Uniject:
Single dose, single package
Prefilled, sterile, non-reusable
Short needles for subQ injection (easier use by non-clinical
personnel/CHWs)
Compact; easy to use and store
Potential “home
run”
10/13/2015 81Dr Shashwat Jani. 9909944160
82. Transdermal delivery system
• Nestorone ( newer progestin ) :
- Available as Cream & Patch.
- Patches used like pills : 3 weeks ON 1 week OFF.
82Dr Shashwat Jani. 990994416010/13/2015
83. VAGINAL RINGS
• LNG ring covered by silastic tube .
• Delivers 20 microgm / day
• Replaced every 3 months.
83Dr Shashwat Jani. 990994416010/13/2015
84. Combined Ring – NUVA RING :
• Soft, transperent, ethinyl
vinyl ring
• Releases EE 15 microgm
+ Etonogestrel daily over
a period of 21 days.
• Then removed , after 1
week ( bleeding ) new
ring inserted.
• S/E : headache,
leucorrhea, vaginitis
Dr Shashwat Jani. 9909944160 8410/13/2015
85. LNG ROD
• Implant with total 150 mg of LNG
( 75 mg / rod ) is found effective for 5 years.
UNIPLANT
• Single rod implant
• Nomegestrol 38 mg.
• Releases 100 microgm / day.
• For 1 year.
85Dr Shashwat Jani. 990994416010/13/2015
86. Biodegradable
• Cipronor ( Single Capsule) – IMPLANTS :
- LNG 26 mg
- begins to disappear after 12 months.
• INJECTABLE :
- Microsphere of 0.06 – 0.1 mm diameter with
Norethindrone with or without EE.
- Given over Gluteal muscle.
- Once injected , can’t be removed.
86Dr Shashwat Jani. 990994416010/13/2015
87. Quinacrine pellet
• It acts as Sclerosing agent
• Inserted transcervically through hysteroscope
in proliferative phase.
• Repeated in next cycle.
• Long term results are awaited.
87Dr Shashwat Jani. 990994416010/13/2015
88. Frameless IUD - Gynefix
• Made of 6 copper beads ( 330 sqmm of Cu )
on monofilament polypropylene thread.
• Thread is knotted at one end , embeded in to
fundal myometrium up to 1 cm.
• Reduced risk of Expulsion, Dysmenorrhoea,
Bleeding , Infection.
• Can be used in Nulliparous.
• Removed with Hook.
88Dr Shashwat Jani. 990994416010/13/2015
90. ESSURE
• Transcervical
sterilisation
• 4 cm long , 2 mm
diameter microcoil
• Spring like device
• Inserted in each
fallopian tube through
hysteroscope.
• Tube is blocked
permanently when scar
tissue grow inside.
90Dr Shashwat Jani. 990994416010/13/2015