This document provides information on various newer approaches to female contraception that are being evaluated globally. It begins by outlining the need for newer contraceptive methods due to unintended pregnancies and non-compliance with existing options. It then evaluates several newer methods including newer pills with modified formulations and dosages, implants, patches, rings, injectables, intrauterine devices, and gene-based and immune-based approaches. Key criteria used to evaluate the methods include efficacy, side effects, ease of use, duration of action, manufacturing costs, and additional health benefits. The document focuses on innovations to existing hormonal methods, particularly a 24+4 regimen oral contraceptive pill containing drospirenone that has demonstrated increased ovulation inhibition,

1. NARENDRA MALHOTRA
M.D., F.I.C.O.G., F.I.C.M.C.H
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Prof. Dubrovick International university,croatia
Indian FOGSI representative to FIGO
President FOGSI (2008)
Dean of I.C.M.U. (2008)
Director Ian Donald School of Ultrasound
National Tech. Advisor for FOGSI-G.O.I.—Mc Arthur Foundation EOC Course
Hon Prof Ob Gyn at DMIMS,Sawangi,Advisor ART unit at MAMC & SMS Jaipur
Editor od SAFOG journal
Chairman publication committee of AOFOG
Practicing Obstetrician Gynecologist at Agra. Special Interest in High Risk Obs., Ultrasound, Laparoscopy
and Infertility, ART & Genetics
Member and Fellow of many Indian and international organisations
FOGSI Imaging Science Chairman (1996-2000)
Awarded best paper and best poster at FOGSI : 5 times, Ethicon fellowship, AOFOG young gyn. award,
Corion award, Man of the year award, Best Citizens of India award
Over 30 published and 100 presented papers
Over 50 guest lectures given in India & Abroad.Presented 10 orations.
Organised many workshops, training programmes, travel seminars and conferences
Editor 8 books, many chapters, on editorial board of many journals
Editor of series of STEP by STEP books
Revising editor for Jeatcoate’s Textbook of Gynaecology (2007) and DONALD OBS MANNUAL(2012)
Very active Sports man, Rotarian and Social worker
MALHOTRA HOSPITALS
84, M.G. Road, Agra-282 010
Phone : (O) 0562-2260275/2260276/2260277, (R) 0562-2260279, (M) 98370-33335; Fax : 0562-2265194
E-mail : mnmhagra10@dataone.in / mnmhagra3@gmail.com
Website : www.malhotrahospitals.com
Apollo Pankaj Hospitals, Agra
Consultant for IVF at jalandhar,ludhiana,ambala,bhiwani,gwalior,allahabad,gorakhpur,udaipur,bariely,jaipur,delhi
Neapal & Bangladesh

2. NO DISCLOSURES
NO CONFLICT OF INTREST
planet earth is getting heavier

3. Evaluation of New Approaches
to
Female Contraception
NARENDRA MALHOTRA
JAIDEEP MALHOTRA
NEHARIKA MALHOTRA BORA
SAMIKSHA GUPTA
PARUL MITTAL
SHEMI BANSAL
KESHAV MALHOTRA
www.rainbowhospitals.org
INDIA
n.malhotra@rainbowhospitals.org

4. I come from AGRA city of Taj Mahal
the biggest ever erection for a woman
THE
MTTBC
MNMH
RAINBOW HOSPITALS

5. AGRA-BOSTON
VIA
DELHI-LONDON

7. population control has been practised from ancient times
when arabs used to insert pebbles in the uterus of female
camels and various concoctions were used for douching just
after and before intercourse
AS THE KNOWLEDGE OF
REPRODUCTIVE PHYSIOLOGY
GREW,NEWER METHODS TO CONTROL
FERTILITY EVOLVED

8. Antiquity: Ancient Egyptian women
use a combination of
cotton, dates, honey and acacia as a
suppository, and it turns out
fermented acacia really does have a
spermicidal effect. The Bible and the
Koran both refer to coitus
interruptus (the withdrawal method).

9. BIRTH CONTROL & PLANNED PARENTHOOD
1914-1921 Activist
Margaret Sanger coins
the term “birth control,”
opens first birth control
clinic in
Brownsville, Brooklyn, an
d starts the American
Birth Control League, the
precursor to Planned
is on. Pincus tests progesterone in
Parenthood. Pincus meet at a 1952 The raceworks. He meets gynecologist John
1951 Sanger and
rats and finds it
Rock, who has already begun testing chemical
dinner party in New York;
contraception in women. Frank Colton, chief chemist at
she persuades him to work on a birth the pharmaceutical company Searle, also independently
control pill.
develops synthetic progesterone

10. Introduction
• Despite of the wide spread
availability of a cafeteria of
contraceptive choices the
world still sees
• a 49% rate of unintended pregnancies
• a 22.5% rate of unintended births
• a 26.5% rate of elective abortions in the U.S.
• In the developing world this
figure may be much higher
60
50
40
30
Seri
20
10
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1
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3

11. POPULATION EXPLOSION
THE “BOMB” HAS EXPLODED IN
DEVELOPING COUNTRIES
POLPULATION CONTROL EXPRESS
HAS DERAILED

12. UN/WORLD BANK
According to projections of the United
Nations (UN) and the World Bank, 80–
90 % of population growth until 2025
will occur in developing countries; 50 %
of population growth is based on increasing
life expectancy attributed to
e. g. better medical care, 17 % of couples
are wishing for more than two children
and 33 % of the population growth stems
from unwanted pregnancies.
www.unfpa.org
WHO www.who.int/reproductivehealth/en
UN : The world at six billion www.u.n.org

13. IS THERE STILL HOPE TO CONTROL
POPULATION ???
• WELL YES AND NO ?
• NO BECAUSE THE BATTLE IS LOST….
• YES BECOS WE CAN STILL HOPE TO STABILSE THE
POPULATION GROWTH BY USE OF NEWER
CONTRACEPTIVE METHODS(SPECIALLY
EDUCATING AND EMPOWERING WOMEN TO
USE NEWER METHODS)

14. Female contraception has given a new
meaning to control of reproduction to a
woman.
Various female contraceptive methods have
flooded the market today and the choice for
the user and also for the provider sometimes
has become difficult.
This presentation aims to evaluate
the various newer approaches to
female contraception in Global
settings.

15. Today a basket of contraceptive choices available to
women and various studies have shown that today even
in the educated and developed world the first year failure
rates are much higher in typical users than perfect users

16. What do women want from an
ideal contraceptive method?
• Highly effective
• Prolonged duration of action
• Rapidly reversible
• Privacy of use
• Protection against STD
• Easily accessible

17. WHY NEWER CONTRACEPTION ?
“Newer”, innovations are needed,and the
obvious answer is because ‘the pill’ will not
work if not taken (for many reasons) and
hormones are not suitable to all women and
what may be good for some, may not be
suitable to everyone

18. WELL THIS IS AN EDITORIAL IN JAN 2013

19. The newer research being done in the
world by only two major
pharmaceuticals who can afford
research
Generics are mainly produced by One .
To find one new substance more than 5000 drugs need to be tested over 10–
15 years, costing 400–800 million US Dollars.
The other three have stopped the research in the field of contraception

20. The newer methods make a
formidable list of additions to the
current choices
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Newer Pills
Newer Barrier methods
Implants
Patches
Rings
Injectables
Microbicides
I.U.C.D.’s(Intrauterine Uterine
Devises)
Transcervical Sterilization
Male hormonal contraception
Gene based approaches
Immune contraception
Anti Progesterone
Surgeryless Contraception
New Fertility awareness based
methods

21. EVALUATION OF NEWER METHODS
HOW??
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Efficacy
Side Effects
Easy use
Compliance
Duration of action
Manufacturing Process
Costs
Newer mode of actions
Additional non-contraceptive benefits
Applicable to masses and acceptance

22. WHO
fertility control in the future will
focus on
1. Improvement of existing methods:
efficacy, side effects, duration of action,
manufacturing process, costs
2. New approaches: more selective
mode of action
3. New targets for contraception

23. INNOVATIONS FOR MODERN
CONTRACEPTIVE METHOD
Modern contraceptive methods have
surprisingly only a short history and has been
dominated by the innovations in the “pill” and
to some extent “other hormonal methods”.
These innovations have mainly targeted
• Tinkering with the pill contents
• Tinkering with the pill dosage
• Tinkering with the routes of administration of
hormonal contraception

25. News about 3rd gen OCPs with
• Contain progestins desogestrel or gestodene
do have increased risk of VTE
– LOE=2a
• Odds of developing a VTE
with 3rd gen OCP was
70% higher than with 2nd gen OCPs

26. Increased Risk of OCP Failure in
Obese Women
• Study showed women with BMI> 27 had 60%
increased pregnancy risk compared to
women with BMI of 21 or less
• Biologic reasons may include:
– higher BMR
– induction of hepatic enzymes
– increased sequestration of hormones in adipose
Holt,VL et al. OB/GYN Jan 2005;105:46-52

27. OCP recommendation for Women
>70 kg
• Consider using OCPs with at least
50 mcg ethinyl estradiol to avoid
contraceptive failure.
• LOE=2b

28. Reality of Non-compliance with OCPs
• Top 3 reasons for missing pills were:
– Being away from home
– Forgetting to take the pill
– Not having a new pack in time for a new menstrual cycle
• Monthly diary cards completed by 141 women over age 18
• 2/3 of pill users missed at least one pill in 3 mos study
• Almost 50% of users missed 2 or more pills in study
Journal of Midwifery& Women’s Health 2005;50:380-5

29. New Oral Contraceptives (OCs) Offer
Continuous Use and
New Progestin Formulations
• Description: Continuous-use products and pills
containing new progestins.
• How they Work: Continuous pill use reduces
menstrual cycles to four per year. New progestins
may reduce side effects.
• Effectiveness: 6-8 pregnancies per 100 women in the
first year. Continuous-use OCs may be more effective.

31. Drospirenone
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Preliminary data suggest efficacy for ACNE /PMDD
Improved QOL indicators(non contraceptive benefits)
Reduced premenstrual sxs from 23% to 11%
Study used only 4 days of placebo instead of 7 days for 64
women in placebo-controlled crossover
• May be as efficacious as SSRI
Contraception 2005;72:414-21

32. Importance of 24 days regimen in OCs?
With lower doses of EE & progestins used in recent OC pills ,
EE & progestions are cleared from the circulation 2-3 days after the
active pill is discontinued
Due to several hormone-free days FSH & LH level start rising
It causes unscheduled uterine bleeding (intermittent bleeding &
spotting) & ovulation too

33. So the call for the time is to
reduce the pill free days
from 7 to 4 i.e 24 +4 regimen

34. Benefits of the 24+4 regimen
increased ovulation inhibition during the HFI
• The increases in levels of LH and FSH, observed with the 7day HFI, were reduced by shortening the HFI to 3 or 4 days
10
8
mIU/mL
Post hoc comparisons of cycles
7-day HFI
3- or 4-day HFI
6
**p<0.01
**
4
**
**
**
**
2
**p<0.01
**p<0.01
0
OC 1
2
3
4 5
LH
6
7 OC
OC 1
2
LH = Luteinizing hormone; FSH = Follicle-stimulating hormone:
HFI = Hormone-free interval; OC = Oral contraceptive
Willis SA, et al. Contraception 2006;74:10–3
3
4 5
FSH
6
7 OC

35. Benefits of the 24+4 regimen
increased ovulation inhibition during the HFI
• Levels of estradiol and inhibin-B, representing ovarian response
to gonadotropin increases, that were observed with the 7-day
HFI was reduced by shortening the HFI
Means for 2 cycles in 12 subjects
80
7-day HFI
3- or 4-day HFI
Post hoc comparisons of cycles
60
pg/mL
*p<0.05 **p<0.01
40
**
**
**
*
20
**
0
**
OC 1
2
3
4
5
6
7
OC
OC 1
2
Estradiol
HFI = Hormone-free interval; OC = Oral contraceptive
Willis SA, et al. Contraception 2006;74:10–3
3
4
5
Inhibin-B
6
7
OC

36. Benefits of the 24+4 regimen
reduced hormonal fluctuations
• The shorter HFI with the 24/4-day regimen results in
less pronounced estradiol fluctuations compared with a
21/7-day regimen
• This may reduce hormone-withdrawal symptoms by
creating more stable hormone levels
Estradiol levels (pg/mL)
40
30
21+7 with drsp ®
24+4 with drsp ®
20
10
0
3
5
8
11
14
Cycle days
Klipping C et al. Contraception 2008;78:16–25
17
20
23
26

37. Benefits of the 24+4 regimen
continuous drospirenone activity
• 24+4 with drsp ® regimen provides 3 extra
days of antimineralocorticoid and
antiandrogenic activity per 28-day cycle
relative to conventional 21+7 day OCs
Drospirenone level
3 extra days of drospirenone
28-day presence™
Cycle 1
1 2 3 4 5 6 7
8
9 10 11 12 13
14
Blode H, et al. Eur J Contracept Reprod Health Care 2000;5:256–64
15 16 17 18 19 20
Cycle 2
21
22 23
24
25 26 27
28
Days

38. More Ovulation Inhibition
24+4 with drsp® has less follicular development even with ‘missed pills’ compared to
21+7 with drsp®M
Percentage of women with follicular development: Hoogland Scores 4-6
% of study population
80
24+4 with drsp®
21+7 with drsp®
60
40
20
0
2nd Cycle
"Missed Pill Cycle"
Hoogland Scores range from 1 to 6,
1 meaning no follicular activity, 6 meaning ovulation
Klipping et al, Contraception 2008

39. How effective is 24+4 with drsp®?
• 24+4 with drsp® has proven its excellent contraceptive efficacy in clinical trials
• Pearl Index*
• 0.80 (upper one-sided 97.5% CI of 1.30) for typical use
• 0.41 (upper one-sided 97.5% CI of 0.85) for perfect use
This corresponds to more than 99% contraceptive protection
*The total number of unplanned pregnancies which occurred per 100 woman-years of use;
CI = confidence interval; Anttila L, et al. Int J Gynecol Obstet. 2009;107(suppl 2):s622

40. Significant reduction in acne lesions with
24+4 with drsp® : pooled data
Cycle 1
Cycle 3
Cycle 6
Percentage reduction in total lesion
count from baseline
0
-10
-20
-30
-40
-50
-60
*p<0.0001 vs. placebo
Koltun W, et al. Int J Gynecol Obstet 2009;107(suppl 2):s620
24+4 with drsp®
Placebo
24+4 with drsp®
was associated
with a greater
reduction from
baseline in total
lesion counts
versus placebo

41. Significant improvement in individual
items with 24+4 with drsp
Item number
0.0
1
2
3
4
5
6
7
8
9
10
11
1.
Change from baseline
-1.5
*
-2.0
-3.5
*
*
* *
24+4 with drsp®
Placebo
*p<0.05 vs. placebo; decrease = improvement
Pearlstein TB, et al. Contraception. 2005;72:414–21;
Bayer Schering Pharma AG, data on file (protocol number 305141)
Difficulty concentrating
7.
Tired, fatigued
8.
*
Diminished interest
6.
*
-2.5
a) Angry, irritable; b) Conflicts
5.
*
a) Mood swings; b) Feel sensitive
4.
* * *
Anxious, tense
3.
-1.0
a) Depressed; b) Hopeless;
c) Worthless, guilty
2.
-0.5
3.0
11 items of Daily Record of Severity of
Problems:
a) Increased appetite;
b) Food cravings
9.
a) Slept more;
b) Trouble sleeping
10. Overwhelmed, lack of control
11. a) Breast tenderness; b) Breast
swelling; c) Bloated sensation;
d) Headache; e) Muscle pain

42. 24+4 with drsp®
now available in India

43. VTE associated with COC use:
a class effect
CLASS EFFECT:
the risk of VTE is increased during COC use
– The risk of VTE during COC use is lower than during pregnancy and childbirth

44. Continuous-Use Regimen Offers New
Choice for Pill Users
• Reduces side effects associated with hormone
withdrawal (migraines, heavy or painful
monthly bleeding).
• Breakthrough bleeding is more likely, but
diminishes after 8 or 9 months of use.
• Seasonale® is packaged specifically for
continuous use and is US FDA approved.
– Users take pill every day for 84 days (12 weeks)
and then take a hormone-free pill for 7 days.

45. Annual (365 days) Regimen – Lybrel
• Approved by FDA on 5/22/2007.
• A low dose pill (20mcg ethinyl estradiol /
90mcg levonorgestrel) taken daily for 364 days
without a placebophase or pill free interval.
• 13 dispenses of 28 active yellow pills.

46. Progestogen only pills,
progesterone only injectables,
contraceptive patches and implants
which are more popular in the developing countries
and why?

47. PICs: Other Benefits
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Do not affect breast feeding
Few side effects
No supplies needed by the client
Can be provided by trained non-medical
staff
• Contain no estrogen
• Do not interfere with intercourse

48. Effective, daily regimen of COCs is
burdensome for many women
Women’s rating of ‘very desirable/absolutely essential’ for
contraceptive attributes
75%
Non-daily regim en
Effective with low
dose of horm one
72%
66%
Is taken m onthly
0%
50%
Percent of wom en
Thompson M. Sexuality, Reproduction and Menopause 2006;4:74–79
100%

49. Women Prefer Monthly Contraceptive
Compared With A Daily Pill Regimen
Prefer m onthly
option with a lower
dose of horm ones
85%
Prefer convenience
of a m onthly option
to a daily pill
84%
Consider switching
to m inim ize
estrogen exposure
80%
77%
78%
79%
80%
81%
82%
83%
Percent of wom en
Synovate Healthcare. Hormonal Contraceptive Claim Test survey data – ExUS, 2009
84%
85%
86%

50. change of routes of hormonal
contraceptives
NEWER DELIVERY ROUTES

51. Comparison of New
Contraceptive Methods
Monthly
injectable
Implant
Intrauterine
system
Ring
Patch
Yes
Yes
Yes
Yes
Yes
1 month
Insertion &
removal
Insertion &
removal
Rx
Rx
Easily
reversible
Yes
Yes
Yes
Yes
Yes
Dosing
frequency
1 month
3-5 yrs
5 yrs
Every 4
weeks
Weekly
Usercontrolled
No
No
No
Yes
Yes
Discreet
Yes
Sometimes
Yes
Yes
Sometimes
Efficacious
Office Visits
www.contraceptiononline.

52. INJECTABLE CONTRACEPTIVES
Progestin – Only Injectables
- Norethindrone enanthate (NET-EN)
- Depot-medroxyprogestrone acetate
- 150mg of DMPA via deep intramuscular
(DMPA).
injecton in gluteal region / deltoid muscle.
- Depo-SubQ Provera 104- 104mg of DMPA via
subcutaneous injection into anterior thigh or
abdomen.
- Duration of protection : 3 months (13 weeks).
- Pearl index of 0.3-0.8 with typical use.

53. New Subcutaneous DMPA Formulation
Recently Approved
• DMPA-SC provides
slower, more
sustained absorption
of the progestin than
conventional DMPA.
• Available only in a
pre-filled Uniject
syringe.

54. New Combined Injectables Offer
Alternative to Progestin-only
Injectables
• Description: Monthly injections containing a
progestin and an estrogen.
• How they work: Injected estrogen and
progestin prevent ovulation, thicken cervical
mucus, and suppress endometrial growth.
• Effectiveness: 0.1 to 0.4 pregnancies per 100
women per year.

55. Combined Injectables Offer Advantages
Over Progestin-Only Injectables
• Irregular bleeding patterns less common and
decrease with length of use.
• Women can become pregnant as soon as six
weeks after last injection.
• Community health workers or women
themselves can administer using Uniject, a
single-use, prefilled, nonreusable syringe.

56. Contraceptive Injection: Lunelle
 Intramuscular injection q 28-30 days
 25 mg medroxyprogesterone acetate/
5 mg estradiol cypionate
 Rapid return to fertility
 Better efficacy than OCPs
 Adverse events are similar to OCPs
 Greater than 90% of users would
recommend to a friend
Kaunitz AM, et al. Contraception. 1999;60:179-187.

57. Contraceptive Implants

58. New Implants Have Fewer Rods than
Norplant®
• Description: One or two progestin-releasing
rods inserted just under the skin.
• How they work: Progestin released under the
skin thickens the cervical mucus, prevents
ovulation in many cycles, and suppresses
endometrial growth.
• Effectiveness: 0.3 to 1.1 pregnancies per 100
women in the first year of use as typically
used.

59. New Implants Offer Several
Improvements Over Norplant
• Levonorgestrel implants:
–
–
–
–
Deliver same daily dose as Norplant
Effective for up to 5 years
Two rods instead of six capsules
Easier to insert and remove than Norplant. Insertions take
less than five minutes.
• Etonogestrel implants:
– Single rod provides at least 3 years of protection against
pregnancy. Users have few if any ovulatory cycles.
• Nestorone implants:
– Single rod designed specifically for breastfeeding
women.

60. Intrauterine Devices

61. New Frameless Design May Reduce Some
Side Effects
• Several copper cylinders
strung together are
anchored into the
uterus.
• May cause less pain and
bleeding
• Requires different
insertion technique
• Less likely to be expelled
when inserted correctly.

62. New Progestin-Releasing Lng -IUS Offers Many
Advantages Over Cu-IUDs
• Approved in 2000 for 5 years
of use. Available in over 100
countries.
• More effective than many CuIUDs.
• Over time causes less bleeding
than Cu-IUDs.
• Can use to treat heavy,
prolonged bleeding or painful
menstrual cramps.

63. Levonorgestrel Intrauterine System:
LNG-IUS
• Releases 20 g of
levonorgestrel per 24 hrs
• Duration: 5 years
• Packaged with sterile inserter
• High efficacy-Pearl Index of 0.1
• Cheaper Indian version now
available for 1/3 the costs
Lahteenmaki P, et al. Steroids. 2000;65:693-697.
www.contraceptiononline.org

64. RINGS

65. New Contraceptive Rings
• Developed by the
Population Council
• Sponsored by
USAID, NICHD, WHO
• One year vaginal ring
• Releases progesterone
receptor (PR) modulator
• Dual-protection ring
• Anti-retroviral agents
• Contraceptive steroids
Delivers Nesterone/EE
150/15 µg/day
13 cycles with 3 weeks
on reinsert after 1 week

66. Vaginal Ring:
 Vaginal ring releases 15
g of ethinyl estradiol and
120 g of etonogestrel
daily
 Worn for 3 out of 4 weeks
 Self insertion and
removal
 Pregnancy rate 0.65 per
100 woman–years
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
www.contraceptiononline.org

67. Vaginal Ring Cycle Control and Tolerability
• Good cycle control
– Irregular bleeding was rare
(2.6% - 6.4% of evaluable cycles)
– Withdrawal bleeding occurred
(97.9% - 99.4% of evaluable cycles)
• Well tolerated and well accepted by users and their
partners (only 5% of partners objected to use)
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
www.contraceptiononline.org

68. Vaginal Ring Compared to OC:
Irregular Bleeding
40
*
NuvaRing
Combined
oral
contraceptive
30
20
10
0
1
2
3
4
*P<0.001 for COC vs NuvaRing
5
6
Cycle Number
Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186:389-395.
www.contraceptiononline.org

69. Most women who try the vaginal ring
report being very satisfied
Patient satisfaction with the vaginal ring versus a pill
Percentage of women
100%
91%
76%
80%
60%
61%
34%
Very
satisfied
Very
satisfied
40%
20%
30%
42%
Satisfied
Satisfied
NuvaRi ng® user s
Pi l l user s
0%

70. Reasons for satisfaction with vaginal ring
The 3 most frequently mentioned responses were:
• Monthly administration (54%)
• Low hormonal dose (31%)
• 100
Ease92 use (27%) 95
of
96
(Very) Satisfied
Proportion of users (%)
Neutral
75
(Very) Dissatisfied
50
25
7
2
4
1
3
1
0
Cycle 3
Cycle 6
Cycle 13
Roumen et al. Eur J Contracept Reprod Health Care 2006;11:14-22

71. Would women recommend
Vaginal Ring to others?
Proportion of users (%)
100
97
75
75
50
25
0
Women who completed the Women who discontinued
study
the study
Dieben T, et al. Obstet Gynecol 2002;100:585-593
Agree

72. PATCHES

73. Contraceptive Patch:
• Patch contains 6 mg
norelgestromin and 0.75 mg
ethinyl estradiol
• Delivers continuous systemic
doses of hormones
– 150 µg norelgestromin (NGMN)
– 20 µg ethinyl estradiol (EE)
Per day
• Direct comparisons to oral
contraceptive delivery doses
cannot be made
www.contraceptiononline.

74. Transdermal Contraceptive Patch
• 3-patch system
– Apply 1 patch each week for 3 weeks
– Apply each patch the same day of the week
• 1 week is patch-free
Patch #1 Patch #2
Patch #3 Patch-free
28-day cycle
28-day cycle
Week 1
Week 2
Week 3
Start next cycle
Week 4
Week 5
Abrams et al. J Clin Pharmacol. 41:1232, 2001
Smallwood et al. Obstet Gynecol. 98:799, 2001

75. Transdermal Contraceptive Patch
Efficacy & Cycle Control
Estrogen-progesterone patch with 7 day patches for 3
weeks, followed by a patch free week
Randomised study in 812 Vs OCs in 605
• Pearl Index marginally lower than OCs
• Higher breakthrough bleeding in first 2 cycles
• More site reactions, mastalgia & dysmenorrhoea
• Perfect compliance in 88.2% with patch & 77.7% with
OCs
Creasy, JAMA, 285:2347, 2001

76. Sites Of Application
-
Buttocks
Upper outer arm
Back
Lower abdomen or
Upper torso excluding
breast

77. News about Patch
• FDA updated labelling since product exposes
women to higher levels of estrogen than
most OCPs
– 60% more estrogen than 35 microgram estrogen
pill
• May increase risk of thrombotic disease
• FDA monitoring safety data closely
• Lawyers already jumping on the band wagon

78. Patch Compared to OC: Adverse Events
Patch (n=812)
OC (n=605)
Overall
Treatment
limiting
Overall
Treatmen
t limiting
Breast
discomfort
19%
1.0%
6%
0.2%
Headache
22%
1.5%
22%
0.3%
Application site
reaction
20%
2.6%
NA
NA
Nausea
20%
1.8%
18%
0.8%
Abdominal pain
8%
0.2%
8%
0.3%
Dysmenorrhea
13%
1.5%
10%
0.2%
Audet MC, et al. JAMA. 2001;285:2347-2354.

79. Spray-On Contraceptives: A New
Technique For Hormone Delivery
• Daily progestin-only sprayon is absorbed into the
skin, then diffuses into
bloodstream.
• Phase I clinical trials
underway in Australia.

80. Contraceptive Gel
Clinical trial of Nestorone gel is applied to the
skin daily for 3 months, suppressed ovulation
in 83% of participants.

81. The need…
Every year, an estimated :
• 20 million unsafe abortions occur
• 80,000 deaths result from
complications of unsafe abortions
• 287,000 maternal deaths occur from
complications of pregnancy and
birth
TIMELY AND PROPER USE OF EMERGENCY CONTRACEPTION
TO PREVENT UNWANTED PREGNANCY CAN SAVE MANY LIVES
AND REDUCE MENTAL TORTURE

82. Emergency Contraception…
is it enough?
• There are safe methods to
prevent pregnancy after
unprotected sex
• How long ago did you have
unprotected sex?
• Could you have been
exposed to STIs/HIV?

83. Emergency Contraception
• Reduce risk of pregnancy
– Use even up to 5 days after unprotected
intercourse
– More effective the sooner taken
• Consider giving pt advance supply at annual PE/pap
– Pregnancy Risk reduced by 75-89%, if taken
within 72 hrs

84. Types of Emergency Contraception
 Progestin-only Oral Contraceptive Pills :
(Emergency Contraceptive Pill)
containing levonorgestrel
 Combined Oral Contraceptive Pills : containing
ethinyl estradiol and levonorgestrel
(Use only pills brands containing these Hormones)
 Insertion of IUCD
 Anti-progestins
(Mifepristone(RU486- 1st gen.Progestrone Receptor Modulator)

85. WHO multicentric randomized trial,
Lancet 2002,360:1803-10
TWO TABLETS (0.75 mg Levonorgestrel each)
TAKEN AS A SINGLE DOSE WITHIN 120
HOURS (5 days) OF EXPOSURE
IS EQUALLY EFFECTIVE

86. IUCD
Inserted within 5 days of unprotected exposure
• mechanical interference with implantation
• Copper is blastocidal
• Can be continued as regular method
• Lowest failure rate--less than 1 %

87. ANTIPROGESTERONES
• Mifepristone(RU486)1st generation
Progestrone Receptor Modulator
• inhibits progesterone
• prevents implantation
• interrupts early pregnancy
• As EC 10 mg single dose within 5 days is
highly effective

88. Luteinizing Hormone
Follicular phase
LH
Theca
cell
Surge
FSH
Cholesterol
GV
Andostendione Aromatization
Resumption
of oocyte
meiosis
Luteal phase
Supporting
corpus luteum
formation
GVB
Estrogens
Synergize
with FSH to
support
estrogen
production
• Cumulus
oophorus
maturation
• Follicular
rupture and
oocyte
expulsion
Progesterone
Production

89. GnRh antagonist
Yuzpe Regimen <72 h
Propose treatment
Bleeding
Menstruation
Follicular
phase
Preovulatory
period
Mid-luteal
phase
Late luteal
phase

90. GnRh Antagonist as EC
Emergency contraception should prevent
pregnancy in 100%
GnRH antagonist as one single injunction seems to
do the work properly
Highly effective - Avoid pregnancy
Free of side effects…….
Easy administered
Affordable

91. Condom Effectiveness vs
Heterosexual HIV Transmission
• Study showed 80% reduction in HIV incidence
with consistent use for all vaginal intercourse
– LOE=1a

92. Female Condom: “Reality”

93. New Female Condoms Are Designed For Better
Fit and Lower Cost
• The PATH Woman’s
Condom:
• FC2 Female Condom:
– Synthetic latex model.
– available in developing
countries in 2005.
• VA Feminine condom:
– First latex model.
– marketed in Western
Europe, Brazil, India, and
South Africa in 2005.
– Designed for nearuniversal fit.
– High user satisfaction
in clinical trials.

94. Vaginal Barrier Methods

95. Summary of Barrier Methods
Contraceptive Technology,18th Revised edition, by Robert Hatcher, MD.

96. New Cervical Caps Designed to Reduce
Fitting Time
• FemCap™
– Silicone rubber device
fits over cervix and
blocks sperm.
– Comes in three sizes; a
provider must check
the fit.
• Ovès™
– Disposable cervical cap made of
silicone.
– Comes in three sizes; a provider
must check the fit.
– Effectiveness has not yet been
established.

97. Contraceptive Sponges
No Fitting or Prescription Required
• The Today Sponge®
– Discontinued in 1994
but recently rereleased in Canada.
– Effectiveness: 13 to
16 pregnancies per
100 users in the first
year as typically
used.
• Protectaid®
– New polyurethane
foam sponge, packed
with spermicide gel F5®.
– Manufacturer plans to
apply for US FDA
approval.
– Effectiveness: 23
pregnancies per 100
users in one year as
typically used.

98. Microbicides
Can Reduce Transmission of HIV and other STIs
• Description: Vaginally applied
substances designed to reduce
transmission of HIV and other STIs.
Some function as spermicides to
provide contraceptive protection.
• How they work: Boost body’s defense
against infection, damage or hinder
disease pathogens, or prevent virus
replication.
• Effectiveness: First microbicides
expected to be 50-60% effective.

99. Why Are Microbicides So Promising?
• Could save many lives by protecting against HIV
infection.
– If 20% of people in high-risk groups used a 60% effective
microbicide, 2.5 million lives would be saved in the first
three years of use.
– Could lead to considerable savings in public health
expenditures.
• Women could control microbicide use.
– Women could protect themselves against STIs when they
cannot use condoms, perhaps without needing the
cooperation of their partners.

100. Microbicide Studies Explore User
Preferences
• Acceptability studies conducted around the
world found that women and men have great
interest in using microbicides.
– Women would prefer a microbicide to be an
odorless, colorless cream placed in the vagina
with applicator.
– Most women, but few men, would prefer a
formulation offering dual protection against both
pregnancy and STIs.

101. New Fertility Awareness-Based Methods
Provide Simplified Ways to Track Fertile Days
• Description: Tracking a woman’s fertility and
avoiding unprotected sex on fertile days
using colored beads or secretion diary.
• How they work: Avoiding unprotected
intercourse during days identified as
probably fertile.
• Effectiveness: Standard Days Method™—12
pregnancies per 100 women per year.
TwoDay Method™—14 pregnancies per 100
women per year.

102. Standard Days Method Tracks Fertility
with CycleBeads™
• Color-coded beads
indicate fertile days.
• Works best for women
who:
– Have cycles between 26
and 32 days long and,
– Most likely ovulate
between days 8 and 19 of
the fertile period.

103. New Sterilization Techniques Offer
Alternative to Surgery
• Description: Procedures that prevent
pregnancy permanently by reaching and
blocking the fallopian tubes though the vagina
and uterus.
• How they work: Blocks egg from descending
from a fallopian tube.
• Effectiveness: 0.2 to 2 pregnancies per 100
women in the first year of use.

104. Transcervical Female Sterilization
New Sterilization Methods are Safer
• Essure®: A spring-like device scars and plugs
the fallopian tubes.
• Quinacrine: A chemical compound scars and
blocks fallopian tubes.
• The Adiana Procedure: A plastic implant is
inserted into a lesion in the fallopian tubes.
Tissue grows into the plug and blocks the
fallopian tubes.

105. Gene-Based Approaches
Promise Dramatic Change in Contraception
• Target the genes or proteins involved in
sperm and egg development.
• In women: target molecules to prevent
ovulation.
• In men: prevent sperm from penetrating an
egg’s outer layer.
• Unlikely to cause side effects.
• At least 10 years away from reaching the
market.

106. The 21st century has brought many many new
innovations in women health care including a
new era of contraceptive choices. This, has
and is, sometimes confusing to the user,
provider and the prescriber.

107. Users’ opinion of best contraceptive
method (baseline)
66
70
% of women
60
50
40
30
16
20
7
5
10
6
0
COC
IUD
Barrier
Other
No preference

108. “Technology made large populations
possible
and large populations make technology
indispensable”

109. Contraception Resources
• Contraceptive Technology,18th Revised edition, by Robert Hatcher, MD
and website at:
http://www.managingcontraception.com/cmanager/publish/
• Managing Contraception Pocket Guide by Robert Hatcher, MD
• Planned Parenthood section on birth control options:
http://www.plannedparenthood.org/pp2/portal/medicalinfo/birthcon
trol/
• Best Method For Me:
http://www.bestmethodforme.com/survey/index.php
• Ortho Personalized Birth Control Selector:
http://www.orthowomenshealth.com/birthcontrol/selector/index.html
• EC Info: NOT-2-LATE.com at: http://ec.princeton.edu/info/contrac.html

110. WELCOME TO INDIA IFFS 2016

111. thank you
“Contraceptives should be used at
every conceivable occasion.”