evaluation of new approaches
TRANSCRIPT
NARENDRA MALHOTRAM.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 HOSPITALS84, M.G. Road, Agra-282 010
Phone : (O) 0562-2260275/2260276/2260277, (R) 0562-2260279, (M) 98370-33335; Fax : 0562-2265194E-mail : [email protected] / [email protected]
Website : www.malhotrahospitals.comApollo Pankaj Hospitals, Agra
Consultant for IVF at jalandhar,ludhiana,ambala,bhiwani,gwalior,allahabad,gorakhpur,udaipur,bariely,jaipur,delhiNeapal & Bangladesh
NO DISCLOSURES NO CONFLICT OF INTREST
planet earth is getting heavier
Evaluation of New Approaches to
Female Contraception
NARENDRA MALHOTRAJAIDEEP MALHOTRA
NEHARIKA MALHOTRA BORASAMIKSHA GUPTA
PARUL MITTALSHEMI BANSAL
KESHAV MALHOTRAwww.rainbowhospitals.org
INDIA
I come from AGRA city of Taj Mahal the biggest ever erection for a woman
THE
MTTBCMNMH
RAINBOW HOSPITALS
AGRA-BOSTONVIA
DELHI-LONDON
AS THE KNOWLEDGE OF REPRODUCTIVE PHYSIOLOGY GREW,NEWER METHODS TO CONTROL FERTILITY EVOLVED
population control has been practised from ancient timeswhen arabs used to insert pebbles in the uterus of female camels and various concoctions were used for douching just after and before intercourse
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).
BIRTH CONTROL & PLANNED PARENTHOOD
1914-1921 Activist Margaret Sanger coins the term “birth control,” opens first birth control clinic in Brownsville, Brooklyn, and starts the American Birth Control League, the precursor to Planned Parenthood.1951 Sanger and Pincus meet at a dinner party in New York; she persuades him to work on a birth control pill.
1952 The race is on. Pincus tests progesterone in rats and finds it works. He meets gynecologist John Rock, who has already begun testing chemical contraception in women. Frank Colton, chief chemist at the pharmaceutical company Searle, also independently develops synthetic progesterone
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
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Series1
POPULATION EXPLOSION THE “BOMB” HAS EXPLODED IN
DEVELOPING COUNTRIES
POLPULATION CONTROL EXPRESS HAS DERAILED
UN/WORLD BANKAccording to projections of the UnitedNations (UN) and the World Bank, 80–90 % of population growth until 2025will occur in developing countries; 50 %of population growth is based on increasinglife expectancy attributed toe. g. better medical care, 17 % of couplesare wishing for more than two childrenand 33 % of the population growth stemsfrom unwanted pregnancies.
www.unfpa.orgWHO www.who.int/reproductivehealth/en UN : The world at six billion www.u.n.org
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)
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.
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
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
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
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 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
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
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
WHO fertility control in the future will focus on
1. Improvement of existing methods: efficacy, side effects, duration of action, manufacturing process, costs2. New approaches: more selective mode of action3. New targets for contraception
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
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
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
OCP recommendation for Women >70 kg
• Consider using OCPs with at least 50 mcg ethinyl estradiol to avoid contraceptive failure.
• LOE=2b
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
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.
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
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
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, observed with the 7-day HFI, were reduced by shortening the HFI to 3 or 4 days
LHOC 1 2 3 4 5 6 7 OC
0
2
4
6
8
10
FSHOC 1 2 3 4 5 6 7 OC
****
****
**
7-day HFI3- or 4-day HFI
mIU
/mL
**p<0.01 **p<0.01
LH = Luteinizing hormone; FSH = Follicle-stimulating hormone:HFI = Hormone-free interval; OC = Oral contraceptive
Post hoc comparisons of cycles
**p<0.01
Willis SA, et al. Contraception 2006;74:10–3
Benefits of the 24+4 regimen increased ovulation inhibition during the HFI
• Levels of estradiol and inhibin-B, representing ovarian responseto gonadotropin increases, that were observed with the 7-day HFI was reduced by shortening the HFI
OC 1 2 3 4 5 6 7 OC0
20
40
60
80
pg/m
L
Inhibin-B
OC 1 2 3 4 5 6 7 OC
** *
****
****
Estradiol
7-day HFI3- or 4-day HFI
*p<0.05 **p<0.01
Means for 2 cycles in 12 subjects
Post hoc comparisons of cycles
Willis SA, et al. Contraception 2006;74:10–3
HFI = Hormone-free interval; OC = Oral contraceptive
Benefits of the 24+4 regimenreduced 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
Klipping C et al. Contraception 2008;78:16–25
21+7 with drsp ® 24+4 with drsp ®
3 5 8 11 14 17 20 23 26
Estrad
iol levels (pg/mL)
Cycle days
0
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30
40
Benefits of the 24+4 regimencontinuous 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
Blode H, et al. Eur J Contracept Reprod Health Care 2000;5:256–64
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Days
Drospire
none
level
Extends into the
4 day hormone-
free interval
3 extra days of drospirenone
Cycle 2
28-day presence™
Cycle 1
More Ovulation Inhibition 24+4 with drsp® has less follicular development even with ‘missed pills’ compared to 21+7 with drsp®M
Klipping et al, Contraception 2008
Hoogland Scores range from 1 to 6, 1 meaning no follicular activity, 6 meaning ovulation
Percentage of women with follicular development: Hoogland Scores 4-6
0
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40
60
80
2nd Cycle "Missed Pill Cycle"
% of study
pop
ulati
on
24+4 with drsp® 21+7 with drsp®
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
Significant reduction in acne lesions with 24+4 with drsp® : pooled data
*p<0.0001 vs. placebo
Koltun W, et al. Int J Gynecol Obstet 2009;107(suppl 2):s620
-60
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-40
-30
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-10
0Cycle 1 Cycle 3 Cycle 6
Percen
tage re
ducti
on in
total lesion
coun
t from baseline
24+4 with drsp® Placebo
24+4 with drsp® was associated with a greater reduction from baseline in total lesion counts versus placebo
Significant improvement in individual items with 24+4 with drsp
1. a) Depressed; b) Hopeless;c) Worthless, guilty
2. Anxious, tense
3. a) Mood swings; b) Feel sensitive
4. a) Angry, irritable; b) Conflicts
5. Diminished interest
6. Difficulty concentrating
7. Tired, fatigued
8. 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
Pearlstein TB, et al. Contraception. 2005;72:414–21;Bayer Schering Pharma AG, data on file (protocol number 305141)
Item number
Chan
ge from
baseline
1
*
24+4 with drsp® Placebo
2
*
3
*
4
*
5
*
6
*
7
*
8
*
9
*
10
*
11
*-3.5
-1.5
-1.0
-0.5
0.0
3.0
-2.5
-2.0
11 items of Daily Record of Severity of Problems:
*p<0.05 vs. placebo; decrease = improvement
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 during COC use is lower than during pregnancy and childbirth
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.
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.
Progestogen only pills, progesterone only injectables,
contraceptive patches and implants which are more popular in the developing countries
and why?
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
Effective, daily regimen of COCs is burdensome for many women
66%
72%
75%
0% 50% 100%
Is taken monthly
Effective with lowdose of hormone
Non-daily regimen
Percent of women
Thompson M. Sexuality, Reproduction and Menopause 2006;4:74–79
Women’s rating of ‘very desirable/absolutely essential’ for contraceptive attributes
Women Prefer Monthly Contraceptive Compared With A Daily Pill Regimen
80%
84%
85%
77% 78% 79% 80% 81% 82% 83% 84% 85% 86%
Consider switchingto minimize
estrogen exposure
Prefer convenienceof a monthly option
to a daily pill
Prefer monthlyoption with a lowerdose of hormones
Percent of women
Synovate Healthcare. Hormonal Contraceptive Claim Test survey data – ExUS, 2009
change of routes of hormonal contraceptives
NEWER DELIVERY ROUTES
Comparison of New Contraceptive Methods
Monthly injectable Implant
Intrauterine system Ring Patch
Efficacious Yes Yes Yes Yes Yes
Office Visits 1 monthInsertion &
removalInsertion &
removalRx Rx
Easily reversible
Yes Yes Yes Yes Yes
Dosing frequency
1 month 3-5 yrs 5 yrsEvery 4 weeks
Weekly
User-controlled
No No No Yes Yes
Discreet Yes Sometimes Yes Yes Sometimes
www.contraceptiononline.org
INJECTABLE CONTRACEPTIVESProgestin – Only Injectables - Norethindrone enanthate (NET-EN) - Depot-medroxyprogestrone acetate (DMPA).
- 150mg of DMPA via deep intramuscular 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.
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.
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.
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.
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.
Contraceptive Implants
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.
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.
Intrauterine Devices
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.
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 Cu-IUDs.
• Over time causes less bleeding than Cu-IUDs.
• Can use to treat heavy, prolonged bleeding or painful menstrual cramps.
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
www.contraceptiononline.orgLahteenmaki P, et al. Steroids. 2000;65:693-697.
RINGS
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/day13 cycles with 3 weeks on reinsert after 1 week
Vaginal Ring:
Roumen FJ, et al. Hum Reprod. 2001;16:469-475. www.contraceptiononline.org
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
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)
www.contraceptiononline.org
Roumen FJ, et al. Hum Reprod. 2001;16:469-475.
0
10
20
30
40
Incid
en
ce o
f Ir
r eg
ula
r b
leed
ing
(%
)
Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186:389-395.
Vaginal Ring Compared to OC:Irregular Bleeding
Cycle Number
NuvaRing
Combined oral contraceptive
1 2 3 4 5 6
*
*P<0.001 for COC vs NuvaRing
www.contraceptiononline.org
Most women who try the vaginal ring report being very satisfied
42%30%
34%61%
0%
20%
40%
60%
80%
100%
NuvaRing® users Pill users
Percenta
ge o
f w
om
en
Patient satisfaction with the vaginal ring versus a pill
Very satisfied
Very satisfied
Satisfied Satisfied
91%
76%
Reasons for satisfaction with vaginal ring
The 3 most frequently mentioned responses were:
• Monthly administration (54%)
• Low hormonal dose (31%)
• Ease of use (27%)
Roumen et al. Eur J Contracept Reprod Health Care 2006;11:14-22
92 95 96
7 4 32 1 10
25
50
75
100
Cycle 3 Cycle 6 Cycle 13
Pro
po
rtio
n o
f u
se
rs (
%)
(Very) Satisfied
Neutral
(Very) Dissatisfied
Would women recommend Vaginal Ring to others?
97
75
0
25
50
75
100
Women who completed thestudy
Women who discontinuedthe study
Prop
ortio
n of
use
rs (%
)
Agree
Dieben T, et al. Obstet Gynecol 2002;100:585-593
PATCHES
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)
• Direct comparisons to oral contraceptive delivery doses cannot be made
Per day
www.contraceptiononline.org
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
Week 1 Week 2 Week 3 Week 4
Patch #1
Patch #2
Patch #3
28-day cycle
Patch-free
Week 5
Start next cycle
28-day cycle
Abrams et al. J Clin Pharmacol. 41:1232, 2001Smallwood et al. Obstet Gynecol. 98:799, 2001
Transdermal Contraceptive PatchEfficacy & 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
Sites Of Application
- 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% 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
Patch Compared to OC: Adverse Events
Audet MC, et al. JAMA. 2001;285:2347-2354.
Patch (n=812) OC (n=605)
OverallTreatment
limiting OverallTreatment
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%
Spray-On Contraceptives: A New Technique For Hormone Delivery
• Daily progestin-only spray-on is absorbed into the skin, then diffuses into bloodstream.
• Phase I clinical trials underway in Australia.
Contraceptive Gel
Clinical trial of Nestorone gel is applied to the skin daily for 3 months, suppressed ovulation in 83% of participants.
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
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?
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
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)
TWO TABLETS (0.75 mg Levonorgestrel each)
TAKEN AS A SINGLE DOSE WITHIN 120 HOURS (5 days) OF EXPOSURE
IS EQUALLY EFFECTIVE
WHO multicentric randomized trial, Lancet 2002,360:1803-10
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 %
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
Luteinizing HormoneLuteinizing Hormone
Follicular phase Surge Luteal phase
Synergize with FSH to support estrogen production
LH
Theca cell
Estrogens
FSH
Cholesterol
AndostendioneAromatization
Supporting corpus luteum
formation
Progesterone
Production
• Cumulus oophorus maturation
• Follicular rupture and oocyte expulsion
Resumption of oocyte meiosis
GV
GVB
Yuzpe Regimen <72 h Propose treatment
Menstruation Follicular phase
Preovulatory period
Mid-luteal phase
Late luteal phase
Bleeding
GnRh antagonist
Emergency contraception should prevent pregnancy in 100%
GnRH antagonist as one single injunction seems to do the work properly
GnRh Antagonist as EC
Highly effective - Avoid pregnancy
Free of side effects…….
Easy administered
Affordable
Condom Effectiveness vs Heterosexual HIV Transmission
• Study showed 80% reduction in HIV incidence with consistent use for all vaginal intercourse– LOE=1a
Female Condom: “Reality”
New Female Condoms Are Designed For Better Fit and Lower Cost
• 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.
• The PATH Woman’s Condom:– Designed for near-
universal fit.– High user satisfaction
in clinical trials.
Vaginal Barrier Methods
Summary of Barrier MethodsContraceptive 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.
– 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.
Contraceptive SpongesNo Fitting or Prescription Required
• The Today Sponge® – Discontinued in 1994
but recently re-released 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 F-5®.
– Manufacturer plans to apply for US FDA approval.
– Effectiveness: 23 pregnancies per 100 users in one year as typically used.
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.
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.
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.
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.
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.
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.
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.
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.
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.
66
5 7 6
16
0
10
20
30
40
50
60
70
COC IUD Barrier Other No preference
Users’ opinion of best contraceptive method (baseline)
% o
f w
omen
“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.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/birthcontrol/
• 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
WELCOME TO INDIA IFFS 2016
thank you
“Contraceptives should be used at every conceivable occasion.”