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NARENDRA MALHOTRA
M.D., F.I.C.O.G., F.I.C.M.C.H
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Prof. Dubrovick International uni...
NO DISCLOSURES
NO CONFLICT OF INTREST

planet earth is getting heavier
Evaluation of New Approaches
to
Female Contraception

NARENDRA MALHOTRA
JAIDEEP MALHOTRA
NEHARIKA MALHOTRA BORA
SAMIKSHA G...
I come from AGRA city of Taj Mahal
the biggest ever erection for a woman
THE

MTTBC
MNMH

RAINBOW HOSPITALS
AGRA-BOSTON
VIA
DELHI-LONDON
population control has been practised from ancient times
when arabs used to insert pebbles in the uterus of female
camels ...
Antiquity: Ancient Egyptian women
use a combination of
cotton, dates, honey and acacia as a
suppository, and it turns out
...
BIRTH CONTROL & PLANNED PARENTHOOD
1914-1921 Activist
Margaret Sanger coins
the term “birth control,”
opens first birth co...
Introduction
• Despite of the wide spread
availability of a cafeteria of
contraceptive choices the
world still sees
• a 49...
POPULATION EXPLOSION
THE “BOMB” HAS EXPLODED IN
DEVELOPING COUNTRIES

POLPULATION CONTROL EXPRESS
HAS DERAILED
UN/WORLD BANK
According to projections of the United
Nations (UN) and the World Bank, 80–
90 % of population growth until ...
IS THERE STILL HOPE TO CONTROL
POPULATION ???

• WELL YES AND NO ?
• NO BECAUSE THE BATTLE IS LOST….
• YES BECOS WE CAN ST...
Female contraception has given a new
meaning to control of reproduction to a
woman.
Various female contraceptive methods h...
Today a basket of contraceptive choices available to
women and various studies have shown that today even
in the educated ...
What do women want from an
ideal contraceptive method?
• Highly effective
• Prolonged duration of action

• Rapidly revers...
WHY NEWER CONTRACEPTION ?
“Newer”, innovations are needed,and the
obvious answer is because ‘the pill’ will not
work if no...
WELL THIS IS AN EDITORIAL IN JAN 2013
The newer research being done in the
world by only two major
pharmaceuticals who can afford
research

Generics are mainly ...
The newer methods make a
formidable list of additions to the
current choices
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Newer Pills
Ne...
EVALUATION OF NEWER METHODS
HOW??
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Efficacy
Side Effects
Easy use
Compliance
Duration of action
Manufa...
WHO
fertility control in the future will
focus on
1. Improvement of existing methods:
efficacy, side effects, duration of ...
INNOVATIONS FOR MODERN
CONTRACEPTIVE METHOD
Modern contraceptive methods have
surprisingly only a short history and has be...
News about 3rd gen OCPs with
• Contain progestins desogestrel or gestodene
do have increased risk of VTE
– LOE=2a

• Odds ...
Increased Risk of OCP Failure in
Obese Women
• Study showed women with BMI> 27 had 60%
increased pregnancy risk compared t...
OCP recommendation for Women
>70 kg
• Consider using OCPs with at least
50 mcg ethinyl estradiol to avoid
contraceptive fa...
Reality of Non-compliance with OCPs
• Top 3 reasons for missing pills were:
– Being away from home
– Forgetting to take th...
New Oral Contraceptives (OCs) Offer
Continuous Use and
New Progestin Formulations
• Description: Continuous-use products a...
Drospirenone
•
•
•
•

Preliminary data suggest efficacy for ACNE /PMDD
Improved QOL indicators(non contraceptive benefits)...
Importance of 24 days regimen in OCs?

With lower doses of EE & progestins used in recent OC pills ,
EE & progestions are ...
So the call for the time is to
reduce the pill free days
from 7 to 4 i.e 24 +4 regimen
Benefits of the 24+4 regimen
increased ovulation inhibition during the HFI

• The increases in levels of LH and FSH, obser...
Benefits of the 24+4 regimen
increased ovulation inhibition during the HFI
• Levels of estradiol and inhibin-B, representi...
Benefits of the 24+4 regimen
reduced hormonal fluctuations

• The shorter HFI with the 24/4-day regimen results in
less pr...
Benefits of the 24+4 regimen
continuous drospirenone activity

• 24+4 with drsp ® regimen provides 3 extra
days of antimin...
More Ovulation Inhibition
24+4 with drsp® has less follicular development even with ‘missed pills’ compared to
21+7 with d...
How effective is 24+4 with drsp®?
• 24+4 with drsp® has proven its excellent contraceptive efficacy in clinical trials

• ...
Significant reduction in acne lesions with
24+4 with drsp® : pooled data
Cycle 1

Cycle 3

Cycle 6

Percentage reduction i...
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.

Ch...
24+4 with drsp®
now available in India
VTE associated with COC use:
a class effect
CLASS EFFECT:
the risk of VTE is increased during COC use
– The risk of VTE du...
Continuous-Use Regimen Offers New
Choice for Pill Users
• Reduces side effects associated with hormone
withdrawal (migrain...
Annual (365 days) Regimen – Lybrel
• Approved by FDA on 5/22/2007.
• A low dose pill (20mcg ethinyl estradiol /
90mcg levo...
Progestogen only pills,
progesterone only injectables,
contraceptive patches and implants
which are more popular in the de...
PICs: Other Benefits
•
•
•
•

Do not affect breast feeding
Few side effects
No supplies needed by the client
Can be provid...
Effective, daily regimen of COCs is
burdensome for many women
Women’s rating of ‘very desirable/absolutely essential’ for
...
Women Prefer Monthly Contraceptive
Compared With A Daily Pill Regimen
Prefer m onthly
option with a lower
dose of horm one...
change of routes of hormonal
contraceptives
NEWER DELIVERY ROUTES
Comparison of New
Contraceptive Methods
Monthly
injectable

Implant

Intrauterine
system

Ring

Patch

Yes

Yes

Yes

Yes
...
INJECTABLE CONTRACEPTIVES
Progestin – Only Injectables
- Norethindrone enanthate (NET-EN)
- Depot-medroxyprogestrone aceta...
New Subcutaneous DMPA Formulation
Recently Approved
• DMPA-SC provides
slower, more
sustained absorption
of the progestin ...
New Combined Injectables Offer
Alternative to Progestin-only
Injectables
• Description: Monthly injections containing a
pr...
Combined Injectables Offer Advantages
Over Progestin-Only Injectables
• Irregular bleeding patterns less common and
decrea...
Contraceptive Injection: Lunelle
 Intramuscular injection q 28-30 days

 25 mg medroxyprogesterone acetate/

5 mg estrad...
Contraceptive Implants
New Implants Have Fewer Rods than
Norplant®
• Description: One or two progestin-releasing
rods inserted just under the ski...
New Implants Offer Several
Improvements Over Norplant
• Levonorgestrel implants:
–
–
–
–

Deliver same daily dose as Norpl...
Intrauterine Devices
New Frameless Design May Reduce Some
Side Effects
• Several copper cylinders
strung together are
anchored into the
uterus....
New Progestin-Releasing Lng -IUS Offers Many
Advantages Over Cu-IUDs
• Approved in 2000 for 5 years
of use. Available in o...
Levonorgestrel Intrauterine System:
LNG-IUS
• Releases 20 g of
levonorgestrel per 24 hrs
• Duration: 5 years
• Packaged wi...
RINGS
New Contraceptive Rings
• Developed by the
Population Council
• Sponsored by
USAID, NICHD, WHO
• One year vaginal ring
• R...
Vaginal Ring:
 Vaginal ring releases 15

g of ethinyl estradiol and
120 g of etonogestrel
daily
 Worn for 3 out of 4 wee...
Vaginal Ring Cycle Control and Tolerability
• Good cycle control

– Irregular bleeding was rare
(2.6% - 6.4% of evaluable ...
Vaginal Ring Compared to OC:
Irregular Bleeding
40

*

NuvaRing

Combined
oral
contraceptive

30
20
10
0

1
2
3
4
*P<0.001...
Most women who try the vaginal ring
report being very satisfied
Patient satisfaction with the vaginal ring versus a pill

...
Reasons for satisfaction with vaginal ring
The 3 most frequently mentioned responses were:
• Monthly administration (54%)
...
Would women recommend
Vaginal Ring to others?

Proportion of users (%)

100

97

75
75

50

25

0
Women who completed the ...
PATCHES
Contraceptive Patch:
• Patch contains 6 mg
norelgestromin and 0.75 mg
ethinyl estradiol
• Delivers continuous systemic
dos...
Transdermal Contraceptive Patch
• 3-patch system
– Apply 1 patch each week for 3 weeks
– Apply each patch the same day of ...
Transdermal Contraceptive Patch
Efficacy & Cycle Control
Estrogen-progesterone patch with 7 day patches for 3
weeks, follo...
Sites Of Application
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Buttocks
Upper outer arm
Back
Lower abdomen or
Upper torso excluding
breast
News about Patch
• FDA updated labelling since product exposes
women to higher levels of estrogen than
most OCPs
– 60% mor...
Patch Compared to OC: Adverse Events
Patch (n=812)

OC (n=605)

Overall

Treatment
limiting

Overall

Treatmen
t limiting
...
Spray-On Contraceptives: A New
Technique For Hormone Delivery
• Daily progestin-only sprayon is absorbed into the
skin, th...
Contraceptive Gel
Clinical trial of Nestorone gel is applied to the
skin daily for 3 months, suppressed ovulation
in 83% o...
The need…
Every year, an estimated :
• 20 million unsafe abortions occur
• 80,000 deaths result from
complications of unsa...
Emergency Contraception…
is it enough?
• There are safe methods to
prevent pregnancy after
unprotected sex
• How long ago ...
Emergency Contraception
• Reduce risk of pregnancy
– Use even up to 5 days after unprotected
intercourse
– More effective ...
Types of Emergency Contraception
 Progestin-only Oral Contraceptive Pills :
(Emergency Contraceptive Pill)
containing lev...
WHO multicentric randomized trial,
Lancet 2002,360:1803-10
TWO TABLETS (0.75 mg Levonorgestrel each)

TAKEN AS A SINGLE DO...
IUCD
Inserted within 5 days of unprotected exposure
• mechanical interference with implantation
• Copper is blastocidal
• ...
ANTIPROGESTERONES
• Mifepristone(RU486)1st generation
Progestrone Receptor Modulator
• inhibits progesterone
• prevents im...
Luteinizing Hormone
Follicular phase

LH

Theca
cell

Surge

FSH

Cholesterol
GV
Andostendione Aromatization

Resumption
o...
GnRh antagonist

Yuzpe Regimen <72 h

Propose treatment

Bleeding

Menstruation

Follicular
phase
Preovulatory
period

Mid...
GnRh Antagonist as EC
Emergency contraception should prevent
pregnancy in 100%
GnRH antagonist as one single injunction se...
Condom Effectiveness vs
Heterosexual HIV Transmission
• Study showed 80% reduction in HIV incidence
with consistent use fo...
Female Condom: “Reality”
New Female Condoms Are Designed For Better
Fit and Lower Cost
• The PATH Woman’s
Condom:
• FC2 Female Condom:
– Synthetic ...
Vaginal Barrier Methods
Summary of Barrier Methods
Contraceptive Technology,18th Revised edition, by Robert Hatcher, MD.
New Cervical Caps Designed to Reduce
Fitting Time
• FemCap™
– Silicone rubber device
fits over cervix and
blocks sperm.
– ...
Contraceptive Sponges
No Fitting or Prescription Required
• The Today Sponge®
– Discontinued in 1994
but recently rereleas...
Microbicides
Can Reduce Transmission of HIV and other STIs
• Description: Vaginally applied
substances designed to reduce
...
Why Are Microbicides So Promising?
• Could save many lives by protecting against HIV
infection.
– If 20% of people in high...
Microbicide Studies Explore User
Preferences
• Acceptability studies conducted around the
world found that women and men h...
New Fertility Awareness-Based Methods
Provide Simplified Ways to Track Fertile Days
• Description: Tracking a woman’s fert...
Standard Days Method Tracks Fertility
with CycleBeads™
• Color-coded beads
indicate fertile days.
• Works best for women
w...
New Sterilization Techniques Offer
Alternative to Surgery
• Description: Procedures that prevent
pregnancy permanently by ...
Transcervical Female Sterilization
New Sterilization Methods are Safer
• Essure®: A spring-like device scars and plugs
the...
Gene-Based Approaches
Promise Dramatic Change in Contraception
• Target the genes or proteins involved in
sperm and egg de...
The 21st century has brought many many new
innovations in women health care including a
new era of contraceptive choices. ...
Users’ opinion of best contraceptive
method (baseline)
66

70

% of women

60
50
40
30
16

20
7

5

10

6

0
COC

IUD

Bar...
“Technology made large populations
possible
and large populations make technology
indispensable”
Contraception Resources
• Contraceptive Technology,18th Revised edition, by Robert Hatcher, MD
and website at:
http://www....
WELCOME TO INDIA IFFS 2016
thank you

“Contraceptives should be used at
every conceivable occasion.”
Evaluation of new approaches
Evaluation of new approaches
Evaluation of new approaches
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  1. 1. NARENDRA MALHOTRA M.D., F.I.C.O.G., F.I.C.M.C.H • • • • • • • • • • • • • • • • • • • • 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. 2. NO DISCLOSURES NO CONFLICT OF INTREST planet earth is getting heavier
  3. 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. 4. I come from AGRA city of Taj Mahal the biggest ever erection for a woman THE MTTBC MNMH RAINBOW HOSPITALS
  5. 5. AGRA-BOSTON VIA DELHI-LONDON
  6. 6. 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
  7. 7. 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).
  8. 8. 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
  9. 9. 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 0 1 2 3
  10. 10. POPULATION EXPLOSION THE “BOMB” HAS EXPLODED IN DEVELOPING COUNTRIES POLPULATION CONTROL EXPRESS HAS DERAILED
  11. 11. 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
  12. 12. 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)
  13. 13. 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.
  14. 14. 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
  15. 15. 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
  16. 16. 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
  17. 17. WELL THIS IS AN EDITORIAL IN JAN 2013
  18. 18. 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
  19. 19. The newer methods make a formidable list of additions to the current choices • • • • • • • • • • • • • • • 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
  20. 20. EVALUATION OF NEWER METHODS HOW?? • • • • • • • • • • 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
  21. 21. 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
  22. 22. 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
  23. 23. 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
  24. 24. 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
  25. 25. OCP recommendation for Women >70 kg • Consider using OCPs with at least 50 mcg ethinyl estradiol to avoid contraceptive failure. • LOE=2b
  26. 26. 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
  27. 27. 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.
  28. 28. Drospirenone • • • • 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
  29. 29. 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
  30. 30. So the call for the time is to reduce the pill free days from 7 to 4 i.e 24 +4 regimen
  31. 31. 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
  32. 32. 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
  33. 33. 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
  34. 34. 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
  35. 35. 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
  36. 36. 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
  37. 37. 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
  38. 38. 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
  39. 39. 24+4 with drsp® now available in India
  40. 40. 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
  41. 41. 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.
  42. 42. 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.
  43. 43. Progestogen only pills, progesterone only injectables, contraceptive patches and implants which are more popular in the developing countries and why?
  44. 44. PICs: Other Benefits • • • • 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
  45. 45. 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%
  46. 46. 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%
  47. 47. change of routes of hormonal contraceptives NEWER DELIVERY ROUTES
  48. 48. 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.
  49. 49. 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.
  50. 50. 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.
  51. 51. 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.
  52. 52. 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.
  53. 53. 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.
  54. 54. Contraceptive Implants
  55. 55. 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.
  56. 56. 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.
  57. 57. Intrauterine Devices
  58. 58. 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.
  59. 59. 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.
  60. 60. 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
  61. 61. RINGS
  62. 62. 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
  63. 63. 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
  64. 64. 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
  65. 65. 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
  66. 66. 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%
  67. 67. 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
  68. 68. 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
  69. 69. PATCHES
  70. 70. 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.
  71. 71. 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
  72. 72. 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
  73. 73. Sites Of Application - Buttocks Upper outer arm Back Lower abdomen or Upper torso excluding breast
  74. 74. 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
  75. 75. 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.
  76. 76. 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.
  77. 77. Contraceptive Gel Clinical trial of Nestorone gel is applied to the skin daily for 3 months, suppressed ovulation in 83% of participants.
  78. 78. 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
  79. 79. 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?
  80. 80. 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
  81. 81. 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)
  82. 82. 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
  83. 83. 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 %
  84. 84. 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
  85. 85. 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
  86. 86. GnRh antagonist Yuzpe Regimen <72 h Propose treatment Bleeding Menstruation Follicular phase Preovulatory period Mid-luteal phase Late luteal phase
  87. 87. 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
  88. 88. Condom Effectiveness vs Heterosexual HIV Transmission • Study showed 80% reduction in HIV incidence with consistent use for all vaginal intercourse – LOE=1a
  89. 89. Female Condom: “Reality”
  90. 90. 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.
  91. 91. Vaginal Barrier Methods
  92. 92. Summary of Barrier Methods Contraceptive Technology,18th Revised edition, by Robert Hatcher, MD.
  93. 93. 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.
  94. 94. 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.
  95. 95. 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.
  96. 96. 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.
  97. 97. 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.
  98. 98. 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.
  99. 99. 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.
  100. 100. 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.
  101. 101. 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.
  102. 102. 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.
  103. 103. 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.
  104. 104. 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
  105. 105. “Technology made large populations possible and large populations make technology indispensable”
  106. 106. 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
  107. 107. WELCOME TO INDIA IFFS 2016
  108. 108. thank you “Contraceptives should be used at every conceivable occasion.”
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