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Recent advances in family
Planning
Ravi M R
Postgraduate student
JSSMC
• World’s population expected to reach 9 billion by
2050.
• India accounts for 17% of world’s population.
Appropriate family planning measures:
1) Would slow the pace of population growth.
2) Decrease abortion related complications and deaths.
3) Cut down maternal care costs.
4) Promote better maternal health.
5) Improve the health of children through better
nutrition and care.
• Current scenario in India:
Couple protection rate: 50.7%
Unmet need=12.8%
In urban population: 9.7%
In rural population: 14.1%
contraceptive prevalence rate: 54.1%
DEFINITION
• ―A way of thinking and living that is adopted
voluntarily, upon the basis of knowledge,
attitudes and responsible decisions by
individuals and couples, in order to promote
the health and welfare of the family group and
thus contribute effectively to the social
development of a country‖.
Objectives
To avoid unwanted births
 To bring about wanted births
 To regulate the intervals between pregnancies
 To control the time at which births occur in relation
to the ages of the parent ; and
 To determine the number of children in the family
1. The United Nations Conference on Human Rights at
Teheran in 1968 recognized family planning as a
basic human right.
2. The Bucharest Conference on the World Population
held in August 1974 endorsed the same view.
'Plan of Action' that
"all couples and individuals have the basic
human right to decide freely and responsibly the
number and spacing of their children and to have the
information, education, and means to do so".
3.The World Conference of the International
Women's Year in 1975 also declared -
―The right of women to decide freely and
responsibly on the number and spacing of their
children and to have access to the information
and means to enable them to exercise that right‖.
Modern concept of family planning
(1) The proper spacing and limitation of births.
(2) Advice on sterility,
(3)Education for parenthood.
(4) Sex education,
(5) Screening for pathological conditions related
reproductive system,
(6)Genetic counseling
(7) Premarital consultation and examination,
(8) Carrying out pregnancy tests,
(9) Marriage counseling,
(10) The preparation of couples for the arrival of their child,
(11) Providing services for unmarried mothers,
(12) Teaching home economics and nutrition,
(13) Providing adoption services
• The objective of the Family Welfare Programme in
India is that people should adopt the "small family
norm" to stabilize the country's population at the level
of some 1,533million by the year 2050 AD.
In the 1970s, - do ya teen bas.
 In the 1980s - 2 - child norm
The current emphasis is on three themes:
"Sons or Daughters – two will do";
"Second child after 3 years", and Universal
Immunization‖.
ELIGIBLE COUPLES
• A currently married couple wherein the wife is
in the reproductive age, which is generally
assumed to lie between the ages of 15 – 45
COUPLE PROTECTION RATE
(CPR)
• An indicator of the prevalence of conraceptive
practice in the community
• It is defined as ―the per cent of eligible couples
effectively protected against childbirth by one or the
other approved methods of family planning‖.
• Demographers are of the view that the demographic
goal of NRR : 1 can be achieved only if the CPR
exceeds 60 per cent.
Evolution of Family Planning Program
• 1951:Family planning programme adopted by government of INDIA
• 1961-66:*Extension education approach
*introduction of IUD
*integrated approach was adopted in 1966
• 19698: * social marketing for Condoms was introduced
* lippes loop was introduced
• 1969-74:Family planning services under PHC
*All INDIA hospital postpartum programme
*Medical termination of pregnancy Act,1971
5th Plan
• 1975-80:Family planning to family welfare programme
*Community Involvement
*Child Marriage restraint Act 1978
6th Plan
• 1985:Strengthening of maternal and child health
*Strengthening family welfare
7th Plan
• Further inclusion of various programmes under MCH
8th Plan
• 1992:Child survival and safe motherhood pragramme
• 1996:Review of safe motherhood component of
CSSM
9th Plan
• 1997:Reproductive and Child health (RCH)
10th plan(2002-2007)
• RCH II was launched with few modifications after
evaluating RCH I
Reproductive and Child Health approach has been defined
as
• ―People have the ability to reproduce and regulate their
fertility.
• Women are able to go through pregnancy and child
birth safely.
• The outcome of pregnancies is successful in terms of
maternal and infant survival and well being
• Couples are able to have sexual relations free of fear of
pregnancy and of contracting disease‖
• Expansion of choices of contraceptives
• Estimated that every additional method, increases the
contraceptive prevalence rate increased by 12 %.
• More methods included are
– Injectable contraceptives –Depo-Provera and
Noristerat
– Centchroman
– Emergency contraception
– Natural methods – LAM, SDM
– Female condoms
• MO of PHC/CHC trained in atleast one method of
sterilisation
• LHVs & ANMs- skilled based clinical training for
spacing methods including IUCD insertion and
removal, LAM, SDM and EC AWWs will be trained for
counselling
• Social marketing of contraceptives, specially in rural
areas will be strengthened
Contraceptive methods
Preventive methods to help women avoid
unwanted pregnancies.
 IDEAL CONTRACEPTIVE
 Safe Effective
Acceptable Inexpensive
Reversible Simple to administer
Independent of coitus
Long lasting to avoid frequent administration
Requiring little or no medical supervision
• The present approach in family planning
programmes is to provide a "cafeteria choice"
that is to offer all methods from which an
individual can choose according to his needs
and wishes and to promote family planning as
a way of life.
Classification of contraceptive methods
I. SPACING METHODS
Barrier
Methods
Physical
Methods
Chemical
Methods
Combined
Methods
Intrauterine
Devices
Hormonal
Methods
Post
Conceptional
Methods
. Miscellaneous
II. TERMINAL METHODS
Male
sterilization
Female
sterilization
Recent advances in family planning
methods
Advances in Male contraception
• Male Hormonal Contraception Methods
• Nonhormonal Methods
Male Hormonal Contraception
Methods
Androgen formulations available for possible
incorporation into a male hormonal contraceptive
regimen
• Testosterone undecanoate
– Dose interval- Oral, twice daily
– Potential concern- Twice daily dosing, short and variable
duration
• 17α-Methyltestosterone
– Dose interval- Oral, daily
– Potential concern- Liver toxicity
• Intramuscular
– Testosterone enanthate
• Dose interval-1–2 wk
• Over all failutre rate was 5.3%, for an overall contraceptive
efficacy of 94.7%
• Potential concern- delay in onset of full contraceptive action for
almost 3-4 months. Injections can be painful, high peak levels.
• Side effects from weekly injections of 200 mg of TE in healthy
men include weight gain, a reversible 25% reduction in
testicular volume, a 6% increase in hemoglobin, and a 10–15%
decrease in serum HDL cholesterol
– Testosterone decanoate
• Dose interval- 4–6 wk
• Potential concern- Injections can be painful, high peak
levels
– Testosterone undecanoate
• Dose interval- 8–12 wk
• Potential concern- Injections can be painful,
nonphysiological pharmacokinetics
• weight gain, a 9% increase in hemoglobin, and a 14%
decrease in HDL
• Subcutaneous
– Testosterone implants
• Dose interval- 4 months
• Potential concern- Surgical placement, occasional
painful expulsions
– MENT(7α-methyl-19-nortestosterone) implant
• Steroidal androgen receptor modulator
• Dose interval- 6 months
• Surgical placement, poor sperm suppression, concern
regarding bone effects
• Transdermal
– Testosterone patch(non scrotal)
• Dose interval- daily
• Potential concern- Poor efficacy, high frequency of skin
irritation
– Testosterone gel
• Dose interval- daily
• Potential concern- Possibility of partner transfer, daily
application needed
– Dihydrotestosterone gel
• Dose interval- daily
• Potential concern- Poor efficacy
• Testosterone buccal system
• Buccal
• Manufactured under trade name Straint
• Dose interval- Daily
• Potential concern- an allergic reaction , Liver toxicity
• Testosterone + 5α-reductase inhibitor
• Dose interval- Injection 1–2 wk, plus daily oral pill
• Potential concern- 5α-Reductase inhibitor gave no
additional contraceptive benefit
Nonhormonal Methods
• Can target either sperm production (testicular targets)
or sperm motility
• Theoretically, agents targeted to these processes
might be very specific, thus lacking the systemic side
effects that plague hormonal method
• Testicular target:
– Adjudin {1-(2,4-dichlorobenzyl)-1H-indazole-3-
carbohydrazide }also known as AF-2364
• an analog of lonidamine (LND)
• disrupt the interaction of spermatid-Sertoli cells by
interacting with specific proteins
• Also know to be a potential anticancer drug
– Indenopyridine, CDB-4022
• targets both Sertoli cells and germ cells
• some studies have demonstrated irreversible testicular
effects of CDB-4022 administration in rodents
• longer-term studies of CDB-4022 in nonhuman primates
will likely be necessary before testing in humans
• Has provided a promising preclinical data for a potential
oral, non hormonal male contraceptive
• Hydrothermal Male Control
– Mild elevations in scrotal temperature, just above
that of the body core, can cause germ cell
apoptosis
– Heat using a scrotal water bath at 43 C (30 min/d
for 6 consecutive days) in combination with
exogenous testosterone decreased sperm count and
motility and increased germ cell apoptosis during
the first 12 wk of treatment compared with
testosterone alone
• Targeting sperm motility
– CatSper Blocker
• sperm-specific transmembrane proteins
• The rise in intracellular calcium mediated by the
CatSpers is directly responsible for the increase in
flagellar beat frequency that characterizes sperm
hyperactivation
• RISUG(Reversible inhibition of sperm under
guidance)
– Is a polymer of styrene maleic anhydride
– Injected into the lumen of the vas deferens using a
no-scalpel technique
– to date both preclinical and clinical studies have
failed to demonstrate reversibility
– A phase III trial of this method is apparently under
way and hopefully will include data on
reversibility
• Contraction Inhibitor Pill ―Dry Orgasm‖
– When segments of vasa deferentia were exposed to
phenoxybenzamine or thioridazine , the longitudinal
smooth muscle fibers did not contract.
– The circular smooth muscles did, causes, clamping the
vas shut.
– Thioridizine’s side effects were so extreme(hives,
difficult breathing;,swelling of face) that the
manufacturer discontinued it in 2005, the common side
effects of phenoxybenzamine are dizziness , fast
heartbeat & stuffy nose.
10/3/2013 40
• Injectable silicone plugs
– Often used by men in China as a potential alternative to
vasectomy.
– There are two tested types of injected plugs
• Medical-grade polyurethane (MPU)
• Medical-grade silicone rubber (MSR).
The polymer (special ingredient) is injected directly into the vasa
differentia, Once injected, the polymer solidifies in place, forming a
flexible plug.
• ORIGAMI Male Condom (OMC)
– The ORIGAMI Male Condom™ (OMC) is the
first NON-rolled, NON- Latex, silicone condom.
– expected to reach the market in early 2015,
pending regulatory approvals.
Advances in female contraception
• Spray On –Contraceptive
 Australian biotech company Acrux has come up
with a world’s first — a contraceptive spray for women.
 Metered Dose Transdermal System (MDTS) to administer a
pre-set dose of the Nestorone to the skin (forearm) every 14
days.
 The fast-drying spray gradually absorbed into the bloodstream.
 Suitable for
Breastfeeding mothers
Who cannot tolerate contraceptive pills with oestrogens.
 Leaves no visible residue & less irritation than patches
SILCS Diaphragm
•Simple-to-use
•Single-size,
•Reusable device with a contoured rim that fits most
women
•diaphragm is made of silicone
• Current status
– Allowed for sales in Europe from march 2013
– Regulatory applications for the US Food and Drug
Administration are under way.
– Health systems assessments in India, South Africa,
and Uganda is being carried out to develop
strategies for its introduction in developing-
country markets.
• Essure
– The Essure procedure involves placing a small &
flexible device called a Micro- insert into each
fallopian tubes.
– The Micro- inserts are made from materials that have
been well studied and used successfully in the heart
and other parts of the human body for many years.
– Once the Micro-inserts are in place, body tissue grows
into the Micro- inserts, blocking the fallopian tubes.
• Adiana
– Two-step procedure comprising
controlled thermal damage of the
endosalpinx followed by insertion of
a biocompatible matrix plug within
the tubal lumen
– scar tissue forms around the silicone
inserts, blocking off the fallopian
tubes and preventing sperm from
reaching the egg
New hormonal implants:
Comparison of Sino-Implant, Jadelle, Implanon
Sino-implant (II) Jadelle Implanon
Manufacturer Shanghai Dahua
Pharmaceutical
Bayer HealthCare Schering Plough /
Organon
Formulation 150 mg levonorgestrel
In 2 rods
150 mg levonorgestrel
In 2 rods
68 mg etonogestrel
In 1 rod
Mean Insertion &
Removal time
Insertion: 2 min
Removal: 4.9 min
Insertion: 2 min
Removal: 4.9 min
Insertion: 1.1 min
Removal: 2.6 min
Labeled duration
of product use
4 years 5 years 3 years
Trocars Disposable Autoclavable /
Disposable
Pre-loaded disposable
Cost of implant
(US$)
$8.00 $21-23 $20
Cost per Year
(if used for
duration)
$2.00 $4.80 $6.70
• Nestorone-Ethinyl Estradiol Contraceptive
Vaginal Ring
– Contains 103 mg Nestorone (NESnew chemical entity)
and 17.4 mg ethinyl estradiol (EE)
– Designed for 13 cycles (1 year) of use
– Ring remains in the vagina for 3 weeks per cycle
followed by a ring-free week
– Easily inserted by the woman; does not require trained
health care provider
– Phase III trial of the NES/EE CVR Has Successfully
Been Completed
New formulation of Depo-Provera:
Depo-subQ Provera 104, for delivery with Uniject
Depo-subQ Provera 104:
 New formulation for subQ injection
 30% lower dose (104 mg vs. 150 mg)
 Rapid onset of action
 Approved by USFDA (2005) and UK
 Potential for home- and self-injection
 Available for roll-out in 2011;
Uniject:
 Single dose, single package
 Prefilled, sterile, non-reusable
 Short needles for subQ injection (easier use by
non-clinical personnel/CHWs)
 Compact; easy to use and store
Potential “home run”
1)Continuous pill (Seasonale):
• 0.15mg levonorgestrel and 0.03mg EE.
• Women take pill for every day for 84 days
(12weeks), and then take hormone –free pills
for 7days
• Yaz: 20 μg EE and 3 mg Drosperinone
regimen.
– has been marketed recently.
– Yaz is currently the only COC with reported
evidence for and approved indication in the
treatment of emotional and physical symptoms of
premenstrual dysphoric disorder
• Ortho-Evra:
– This combined patch delivers 150mcg of
progestogen and 20 mcg of EE per day.
– Failure rate is 0.3 per 100 women.
– Effectiveness is as good as the combined pill.
– S/E: Breakthrough bleeding and mastalgia.
• Anti-Fertility Vaccines
– Contraceptive vaccine either target
• Gamete production ( FSH and LH)
• Gamete function
• Gamete outcome (hCG).
CVs targeting gamete function are better choices
but induce oophoritis affecting sex steroids.
The hCG vaccine is the first vaccine to undergo
phase I and II clinical trials. Both the efficacy and the
lack of immunotoxicity have been reasonably well
demonstrated for this vaccine.
• Praneem
– polyherbal cream, a spermicidal formulation.
– purified extract from the dried seeds of an ancient
Indian plant Azadirachta indica (Neem)
– formulation has shown high contraceptive efficacy
in rabbits and in monkeys after intravaginal
application
• BufferGel
– is a spermicidal gel being studied as a microbicide
active against HIV
• Duet :
– Disposable diaphragm in development that will be
pre-filled with BufferGel.
– It is designed to deliver microbicide to both the
cervix and vagina
• Newer Natural methods
– Standard Days Method
– The Two Day Method
• From a global standpoint, there is clearly a desire and
need for more contraceptive options.
• Couples desire more choices for fertility control, and
unplanned pregnancies continue to occur at alarming
rates
• The hormonal approach to male contraception has
made significant progress in the last decade in terms
of clinical development
• Unfortunately, over the last few yr, the major
pharmaceutical sponsors of male hormonal
contraceptive research have withdrawn their support
in this area of product development, making it
difficult to complete the final phases of clinical
development
• Government and not-for-profit sponsors will be
needed in this environment to devote the necessary
resources for long-term efficacy studies
• India is the 7th largest country but 2nd populous
country in the world.
• We are crossing 1.21 billion in population.
• We should take proper measures to control population
other wise we may run out of food and basic
facilities.
• ―Delay the first, postpone the second and prevent the
third‖.
References
• Park K. Textbook of Preventive and Social Medicine. 21st
ed. Jabalpur(India): Banarsidas Bhanot Publishers; 2011
• Text book of public health and community medicine. 1st ed.
Pune (India). Dept. of Community Medicine AFMC; 2009
• World Health Organization Department of Reproductive
Health and Research (WHO/RHR) and Johns Hopkins
Bloomberg School of Public Health/Center for
Communication Programs (CCP), Knowledge for Health
Project. Family Planning: A Global Handbook for
Providers (2011 update). Baltimore and Geneva: CCP and
WHO, 2011
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528850
accessed on 26/08/2013 17.30hours
• http://www.path.org/projects/silcs.php accessed on
26/08/2013 18.00 hours
• http://www.ncbi.nlm.nih.gov/pubmed/17218411 accessed
on 26/08/2013 18.20 hours
• http://www.mayoclinic.com/health accessed on
24/08/2013 15.00 hours
• http://www.contracept.org accessed on 24/08/2013 15.10
hours
Recent advances in family planning

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Recent advances in family planning

  • 1. Recent advances in family Planning Ravi M R Postgraduate student JSSMC
  • 2. • World’s population expected to reach 9 billion by 2050. • India accounts for 17% of world’s population.
  • 3. Appropriate family planning measures: 1) Would slow the pace of population growth. 2) Decrease abortion related complications and deaths. 3) Cut down maternal care costs. 4) Promote better maternal health. 5) Improve the health of children through better nutrition and care.
  • 4. • Current scenario in India: Couple protection rate: 50.7% Unmet need=12.8% In urban population: 9.7% In rural population: 14.1% contraceptive prevalence rate: 54.1%
  • 5. DEFINITION • ―A way of thinking and living that is adopted voluntarily, upon the basis of knowledge, attitudes and responsible decisions by individuals and couples, in order to promote the health and welfare of the family group and thus contribute effectively to the social development of a country‖.
  • 6. Objectives To avoid unwanted births  To bring about wanted births  To regulate the intervals between pregnancies  To control the time at which births occur in relation to the ages of the parent ; and  To determine the number of children in the family
  • 7. 1. The United Nations Conference on Human Rights at Teheran in 1968 recognized family planning as a basic human right. 2. The Bucharest Conference on the World Population held in August 1974 endorsed the same view. 'Plan of Action' that "all couples and individuals have the basic human right to decide freely and responsibly the number and spacing of their children and to have the information, education, and means to do so".
  • 8. 3.The World Conference of the International Women's Year in 1975 also declared - ―The right of women to decide freely and responsibly on the number and spacing of their children and to have access to the information and means to enable them to exercise that right‖.
  • 9. Modern concept of family planning (1) The proper spacing and limitation of births. (2) Advice on sterility, (3)Education for parenthood. (4) Sex education, (5) Screening for pathological conditions related reproductive system, (6)Genetic counseling
  • 10. (7) Premarital consultation and examination, (8) Carrying out pregnancy tests, (9) Marriage counseling, (10) The preparation of couples for the arrival of their child, (11) Providing services for unmarried mothers, (12) Teaching home economics and nutrition, (13) Providing adoption services
  • 11. • The objective of the Family Welfare Programme in India is that people should adopt the "small family norm" to stabilize the country's population at the level of some 1,533million by the year 2050 AD. In the 1970s, - do ya teen bas.  In the 1980s - 2 - child norm
  • 12. The current emphasis is on three themes: "Sons or Daughters – two will do"; "Second child after 3 years", and Universal Immunization‖.
  • 13. ELIGIBLE COUPLES • A currently married couple wherein the wife is in the reproductive age, which is generally assumed to lie between the ages of 15 – 45
  • 14. COUPLE PROTECTION RATE (CPR) • An indicator of the prevalence of conraceptive practice in the community • It is defined as ―the per cent of eligible couples effectively protected against childbirth by one or the other approved methods of family planning‖. • Demographers are of the view that the demographic goal of NRR : 1 can be achieved only if the CPR exceeds 60 per cent.
  • 15. Evolution of Family Planning Program • 1951:Family planning programme adopted by government of INDIA • 1961-66:*Extension education approach *introduction of IUD *integrated approach was adopted in 1966 • 19698: * social marketing for Condoms was introduced * lippes loop was introduced • 1969-74:Family planning services under PHC *All INDIA hospital postpartum programme *Medical termination of pregnancy Act,1971
  • 16. 5th Plan • 1975-80:Family planning to family welfare programme *Community Involvement *Child Marriage restraint Act 1978 6th Plan • 1985:Strengthening of maternal and child health *Strengthening family welfare 7th Plan • Further inclusion of various programmes under MCH
  • 17. 8th Plan • 1992:Child survival and safe motherhood pragramme • 1996:Review of safe motherhood component of CSSM 9th Plan • 1997:Reproductive and Child health (RCH) 10th plan(2002-2007) • RCH II was launched with few modifications after evaluating RCH I
  • 18. Reproductive and Child Health approach has been defined as • ―People have the ability to reproduce and regulate their fertility. • Women are able to go through pregnancy and child birth safely. • The outcome of pregnancies is successful in terms of maternal and infant survival and well being • Couples are able to have sexual relations free of fear of pregnancy and of contracting disease‖
  • 19.
  • 20. • Expansion of choices of contraceptives • Estimated that every additional method, increases the contraceptive prevalence rate increased by 12 %. • More methods included are – Injectable contraceptives –Depo-Provera and Noristerat – Centchroman – Emergency contraception – Natural methods – LAM, SDM – Female condoms
  • 21. • MO of PHC/CHC trained in atleast one method of sterilisation • LHVs & ANMs- skilled based clinical training for spacing methods including IUCD insertion and removal, LAM, SDM and EC AWWs will be trained for counselling • Social marketing of contraceptives, specially in rural areas will be strengthened
  • 22. Contraceptive methods Preventive methods to help women avoid unwanted pregnancies.  IDEAL CONTRACEPTIVE  Safe Effective Acceptable Inexpensive Reversible Simple to administer Independent of coitus Long lasting to avoid frequent administration Requiring little or no medical supervision
  • 23. • The present approach in family planning programmes is to provide a "cafeteria choice" that is to offer all methods from which an individual can choose according to his needs and wishes and to promote family planning as a way of life.
  • 24. Classification of contraceptive methods I. SPACING METHODS Barrier Methods Physical Methods Chemical Methods Combined Methods Intrauterine Devices Hormonal Methods Post Conceptional Methods . Miscellaneous II. TERMINAL METHODS Male sterilization Female sterilization
  • 25. Recent advances in family planning methods
  • 26. Advances in Male contraception • Male Hormonal Contraception Methods • Nonhormonal Methods
  • 27. Male Hormonal Contraception Methods Androgen formulations available for possible incorporation into a male hormonal contraceptive regimen • Testosterone undecanoate – Dose interval- Oral, twice daily – Potential concern- Twice daily dosing, short and variable duration • 17α-Methyltestosterone – Dose interval- Oral, daily – Potential concern- Liver toxicity
  • 28. • Intramuscular – Testosterone enanthate • Dose interval-1–2 wk • Over all failutre rate was 5.3%, for an overall contraceptive efficacy of 94.7% • Potential concern- delay in onset of full contraceptive action for almost 3-4 months. Injections can be painful, high peak levels. • Side effects from weekly injections of 200 mg of TE in healthy men include weight gain, a reversible 25% reduction in testicular volume, a 6% increase in hemoglobin, and a 10–15% decrease in serum HDL cholesterol
  • 29. – Testosterone decanoate • Dose interval- 4–6 wk • Potential concern- Injections can be painful, high peak levels – Testosterone undecanoate • Dose interval- 8–12 wk • Potential concern- Injections can be painful, nonphysiological pharmacokinetics • weight gain, a 9% increase in hemoglobin, and a 14% decrease in HDL
  • 30. • Subcutaneous – Testosterone implants • Dose interval- 4 months • Potential concern- Surgical placement, occasional painful expulsions – MENT(7α-methyl-19-nortestosterone) implant • Steroidal androgen receptor modulator • Dose interval- 6 months • Surgical placement, poor sperm suppression, concern regarding bone effects
  • 31. • Transdermal – Testosterone patch(non scrotal) • Dose interval- daily • Potential concern- Poor efficacy, high frequency of skin irritation – Testosterone gel • Dose interval- daily • Potential concern- Possibility of partner transfer, daily application needed – Dihydrotestosterone gel • Dose interval- daily • Potential concern- Poor efficacy
  • 32. • Testosterone buccal system • Buccal • Manufactured under trade name Straint • Dose interval- Daily • Potential concern- an allergic reaction , Liver toxicity
  • 33. • Testosterone + 5α-reductase inhibitor • Dose interval- Injection 1–2 wk, plus daily oral pill • Potential concern- 5α-Reductase inhibitor gave no additional contraceptive benefit
  • 34. Nonhormonal Methods • Can target either sperm production (testicular targets) or sperm motility • Theoretically, agents targeted to these processes might be very specific, thus lacking the systemic side effects that plague hormonal method
  • 35. • Testicular target: – Adjudin {1-(2,4-dichlorobenzyl)-1H-indazole-3- carbohydrazide }also known as AF-2364 • an analog of lonidamine (LND) • disrupt the interaction of spermatid-Sertoli cells by interacting with specific proteins • Also know to be a potential anticancer drug
  • 36. – Indenopyridine, CDB-4022 • targets both Sertoli cells and germ cells • some studies have demonstrated irreversible testicular effects of CDB-4022 administration in rodents • longer-term studies of CDB-4022 in nonhuman primates will likely be necessary before testing in humans • Has provided a promising preclinical data for a potential oral, non hormonal male contraceptive
  • 37. • Hydrothermal Male Control – Mild elevations in scrotal temperature, just above that of the body core, can cause germ cell apoptosis – Heat using a scrotal water bath at 43 C (30 min/d for 6 consecutive days) in combination with exogenous testosterone decreased sperm count and motility and increased germ cell apoptosis during the first 12 wk of treatment compared with testosterone alone
  • 38. • Targeting sperm motility – CatSper Blocker • sperm-specific transmembrane proteins • The rise in intracellular calcium mediated by the CatSpers is directly responsible for the increase in flagellar beat frequency that characterizes sperm hyperactivation
  • 39. • RISUG(Reversible inhibition of sperm under guidance) – Is a polymer of styrene maleic anhydride – Injected into the lumen of the vas deferens using a no-scalpel technique – to date both preclinical and clinical studies have failed to demonstrate reversibility – A phase III trial of this method is apparently under way and hopefully will include data on reversibility
  • 40. • Contraction Inhibitor Pill ―Dry Orgasm‖ – When segments of vasa deferentia were exposed to phenoxybenzamine or thioridazine , the longitudinal smooth muscle fibers did not contract. – The circular smooth muscles did, causes, clamping the vas shut. – Thioridizine’s side effects were so extreme(hives, difficult breathing;,swelling of face) that the manufacturer discontinued it in 2005, the common side effects of phenoxybenzamine are dizziness , fast heartbeat & stuffy nose. 10/3/2013 40
  • 41. • Injectable silicone plugs – Often used by men in China as a potential alternative to vasectomy. – There are two tested types of injected plugs • Medical-grade polyurethane (MPU) • Medical-grade silicone rubber (MSR). The polymer (special ingredient) is injected directly into the vasa differentia, Once injected, the polymer solidifies in place, forming a flexible plug.
  • 42. • ORIGAMI Male Condom (OMC) – The ORIGAMI Male Condom™ (OMC) is the first NON-rolled, NON- Latex, silicone condom. – expected to reach the market in early 2015, pending regulatory approvals.
  • 43. Advances in female contraception • Spray On –Contraceptive  Australian biotech company Acrux has come up with a world’s first — a contraceptive spray for women.  Metered Dose Transdermal System (MDTS) to administer a pre-set dose of the Nestorone to the skin (forearm) every 14 days.  The fast-drying spray gradually absorbed into the bloodstream.  Suitable for Breastfeeding mothers Who cannot tolerate contraceptive pills with oestrogens.  Leaves no visible residue & less irritation than patches
  • 44. SILCS Diaphragm •Simple-to-use •Single-size, •Reusable device with a contoured rim that fits most women •diaphragm is made of silicone
  • 45. • Current status – Allowed for sales in Europe from march 2013 – Regulatory applications for the US Food and Drug Administration are under way. – Health systems assessments in India, South Africa, and Uganda is being carried out to develop strategies for its introduction in developing- country markets.
  • 46. • Essure – The Essure procedure involves placing a small & flexible device called a Micro- insert into each fallopian tubes. – The Micro- inserts are made from materials that have been well studied and used successfully in the heart and other parts of the human body for many years. – Once the Micro-inserts are in place, body tissue grows into the Micro- inserts, blocking the fallopian tubes.
  • 47. • Adiana – Two-step procedure comprising controlled thermal damage of the endosalpinx followed by insertion of a biocompatible matrix plug within the tubal lumen – scar tissue forms around the silicone inserts, blocking off the fallopian tubes and preventing sperm from reaching the egg
  • 48. New hormonal implants: Comparison of Sino-Implant, Jadelle, Implanon Sino-implant (II) Jadelle Implanon Manufacturer Shanghai Dahua Pharmaceutical Bayer HealthCare Schering Plough / Organon Formulation 150 mg levonorgestrel In 2 rods 150 mg levonorgestrel In 2 rods 68 mg etonogestrel In 1 rod Mean Insertion & Removal time Insertion: 2 min Removal: 4.9 min Insertion: 2 min Removal: 4.9 min Insertion: 1.1 min Removal: 2.6 min Labeled duration of product use 4 years 5 years 3 years Trocars Disposable Autoclavable / Disposable Pre-loaded disposable Cost of implant (US$) $8.00 $21-23 $20 Cost per Year (if used for duration) $2.00 $4.80 $6.70
  • 49. • Nestorone-Ethinyl Estradiol Contraceptive Vaginal Ring – Contains 103 mg Nestorone (NESnew chemical entity) and 17.4 mg ethinyl estradiol (EE) – Designed for 13 cycles (1 year) of use – Ring remains in the vagina for 3 weeks per cycle followed by a ring-free week – Easily inserted by the woman; does not require trained health care provider – Phase III trial of the NES/EE CVR Has Successfully Been Completed
  • 50. New formulation of Depo-Provera: Depo-subQ Provera 104, for delivery with Uniject Depo-subQ Provera 104:  New formulation for subQ injection  30% lower dose (104 mg vs. 150 mg)  Rapid onset of action  Approved by USFDA (2005) and UK  Potential for home- and self-injection  Available for roll-out in 2011; Uniject:  Single dose, single package  Prefilled, sterile, non-reusable  Short needles for subQ injection (easier use by non-clinical personnel/CHWs)  Compact; easy to use and store Potential “home run”
  • 51. 1)Continuous pill (Seasonale): • 0.15mg levonorgestrel and 0.03mg EE. • Women take pill for every day for 84 days (12weeks), and then take hormone –free pills for 7days
  • 52. • Yaz: 20 μg EE and 3 mg Drosperinone regimen. – has been marketed recently. – Yaz is currently the only COC with reported evidence for and approved indication in the treatment of emotional and physical symptoms of premenstrual dysphoric disorder
  • 53. • Ortho-Evra: – This combined patch delivers 150mcg of progestogen and 20 mcg of EE per day. – Failure rate is 0.3 per 100 women. – Effectiveness is as good as the combined pill. – S/E: Breakthrough bleeding and mastalgia.
  • 54. • Anti-Fertility Vaccines – Contraceptive vaccine either target • Gamete production ( FSH and LH) • Gamete function • Gamete outcome (hCG). CVs targeting gamete function are better choices but induce oophoritis affecting sex steroids. The hCG vaccine is the first vaccine to undergo phase I and II clinical trials. Both the efficacy and the lack of immunotoxicity have been reasonably well demonstrated for this vaccine.
  • 55. • Praneem – polyherbal cream, a spermicidal formulation. – purified extract from the dried seeds of an ancient Indian plant Azadirachta indica (Neem) – formulation has shown high contraceptive efficacy in rabbits and in monkeys after intravaginal application
  • 56. • BufferGel – is a spermicidal gel being studied as a microbicide active against HIV • Duet : – Disposable diaphragm in development that will be pre-filled with BufferGel. – It is designed to deliver microbicide to both the cervix and vagina
  • 57. • Newer Natural methods – Standard Days Method – The Two Day Method
  • 58. • From a global standpoint, there is clearly a desire and need for more contraceptive options. • Couples desire more choices for fertility control, and unplanned pregnancies continue to occur at alarming rates • The hormonal approach to male contraception has made significant progress in the last decade in terms of clinical development
  • 59. • Unfortunately, over the last few yr, the major pharmaceutical sponsors of male hormonal contraceptive research have withdrawn their support in this area of product development, making it difficult to complete the final phases of clinical development • Government and not-for-profit sponsors will be needed in this environment to devote the necessary resources for long-term efficacy studies
  • 60. • India is the 7th largest country but 2nd populous country in the world. • We are crossing 1.21 billion in population. • We should take proper measures to control population other wise we may run out of food and basic facilities. • ―Delay the first, postpone the second and prevent the third‖.
  • 61. References • Park K. Textbook of Preventive and Social Medicine. 21st ed. Jabalpur(India): Banarsidas Bhanot Publishers; 2011 • Text book of public health and community medicine. 1st ed. Pune (India). Dept. of Community Medicine AFMC; 2009 • World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), Knowledge for Health Project. Family Planning: A Global Handbook for Providers (2011 update). Baltimore and Geneva: CCP and WHO, 2011
  • 62. • http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528850 accessed on 26/08/2013 17.30hours • http://www.path.org/projects/silcs.php accessed on 26/08/2013 18.00 hours • http://www.ncbi.nlm.nih.gov/pubmed/17218411 accessed on 26/08/2013 18.20 hours • http://www.mayoclinic.com/health accessed on 24/08/2013 15.00 hours • http://www.contracept.org accessed on 24/08/2013 15.10 hours