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New Contraceptives for Men. SWEET Seminar December 2007. Kirsten Thompson, Director Male Contraception Coalition [email protected] www.IMCCoaltion.org. What we’ll cover today. Why family planning remains relevant Why male contraceptives are important

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new contraceptives for men

New Contraceptives for Men

SWEET SeminarDecember 2007

Kirsten Thompson, DirectorMale Contraception [email protected]

what we ll cover today
What we’ll cover today
  • Why family planning remains relevant
  • Why male contraceptives are important
  • Evidence of a male contraceptive market
  • 5 male contraceptives in or approaching clinical trials
what is a contraceptive
What is a contraceptive?
  • Is contraception inherently inconvenient?
  • What doesn’t a contraceptive do?
the big picture
The big picture
  • Worldwide, fertility is declining
  • Desired family size is a moving target
  • Unmet need remains substantial
  • Method mix is a quality indicator
  • Dissatisfaction / discontinuation / lack of compliance with existing methods
do men want new options
Do men want new options?

We get letters every day from men around the world asking: “How can I get access to these new contraceptives?”

do men want new options6
Do men want new options?

Over 40% of US couples rely on the currently available male contraceptives

Source: CDC (2006) Health, United States

surveys say yes
Surveys say “Yes”
  • In 12 countries, the majority of men would use a new hormonal male contraceptive
    • 50% of US men
  • Men are motivated by desire to share family planning responsibility & have direct control over their fertility

Sources: Martin (2000) Human Reproduction 15(3): 637-45.Heinemann (2005) Human Reproduction 20(2): 549-56.MCC (2007) Male Contraception Quarterly 3: 1-4.

what do women think
What do women think?

Only 2-3% wouldn’t trust their partners to use a male contraceptive

Sources: Glasier (2000) Human Reproduction 15(3): 646-9. MCC (2007) Male Contraception Quarterly 3: 1-4. KFF (1997) Men’s Role in Preventing Pregnancy.

which male contraceptives are closest to market
Which male contraceptives are closest to market?

Three methods are in clinical trials:

  • RISUG
  • The Intra Vas Device (IVD)
  • Male hormonal contraceptives

Two interesting pre-clinical leads:

  • Adjudin
  • RAR antagonist
risug what is it
RISUG – What is it?
  • A polymer gel injected into the vasa deferentia
  • Partially blocks the lumen and disrupts passing sperm
  • Now in Phase III clinical trials in India
risug how effective is it
RISUG – How effective is it?
  • Extremely effective (>99%)

200+ men have been treated with RISUG 2 pregnancies: 1 due to improper delivery, 1 due to marital infidelity

  • Long-lasting

The first clinical trial volunteers received RISUG in 1992; Informal follow-up visits show they still have effective contraception today

Sources: Guha (1993) Contraception 48(4): 367-75. Guha (1997) Contraception 56(4): 245-50.

risug side effects
RISUG – Side effects
  • Transient, painless scrotal swelling which resolves with no intervention within 2 weeks
  • Prostate indicators all healthy after 8 years of RISUG use in Phase II trial volunteers
  • Zero clinical trial attrition to date

Source: Sharma (2001) Reproduction 122(3): 431-6.

risug how is it reversed
RISUG – How is it reversed?
  • Reversal proven in monkeys after 1½ years of use, all had normal sperm count within 3 months of reversal
  • Sodium bicarbonate solution
  • Multiple injections and reversals effective in monkeys
  • Not yet (formally) tested in men

Sources: Lohiya (2000) Int J of Andrology 23(1): 36-42. Lohiya (2005) Contraception 71(3): 214-26.

the ivd what is it
The IVD – What is it?
  • US design in Phase I trials: dual silicone plugs inserted into the vas block sperm
  • Chinese design has completed Phase II trials: single urethane stent filled with nylon mesh allows vasal fluid to pass but traps sperm
ivd how effective is it
IVD – How effective is it?
  • US design awaiting completion of trial; past designs 90-100% effective
  • Chinese design 100% effective, no pregnancies in 123 couples in 1 year
  • Like vasectomy, effective after 3 months
  • Sperm count required to confirm
ivd side effects
IVD – Side effects
  • Similar to “no scalpel vasectomy”, but less frequent and less severe
  • 10% reported mild pain, 3% developed granulomas
  • No spontaneous reversal, no congestive epididymitis
  • Higher satisfaction rate than NSV

Source: Song (2006) Int J Andrology 29(4): 489-95.

ivd how is it reversed
IVD – How is it reversed?
  • Reversal proven in primates after 7 months of use, all had normal sperm count within 1 month of reversal
  • Another 20 minute out-patient procedure required to remove, as opposed to 3-4 hours of microsurgery for vasovasostomy
  • Not yet tested in men

Source: Zaneveld (1999) In Rajalakshmi & Griffin (eds.), Male Contraception: Present and Future, p. 293.

hormonal methods
Hormonal methods
  • Men’s and women’s hormones are analogous in function
  • LH stimulates T production in Leydig cells
  • FSH stimulates spermatid production when T is present
  • Blood-testis barrier regulates internal testes environment
mhcs what are they
MHCs – What are they?
  • Supra-physiological dose of testosterone suppresses testicular production of T and halts spermatogenesis
  • May include a progestin for faster, more complete suppression
  • No orally available T; delivery via implants, depot injections, transdermal gels and patches
mhcs formulations
MHCs – Formulations

T-only formulations are more effective for Asian men

mhcs formulations22
MHCs – Formulations

T + progestin formulations effective for all

mhcs how effective are they
MHCs – How effective are they?
  • Varies by formulation and population
  • Two important trials:
    • WHO’s monthly im depot TU 97.7% effective in Chinese men
    • Monash Medical Center’s T pellets every 4 months + im DMPA every 3 months 100% effective in Australian men
  • 3-10% “Non-responders”

Sources: Gu (2003) JCEM 88(2):562–568. Turner (2003) JCEM 88(10):4659–4667.

mhcs non responders
MHCs – “Non-responders”
  • Central mystery of MHCsSome men keep producing sperm despite extreme suppression of FSH and LH
  • Theories:
    • genetic differences in androgen regulation
    • phytoestrogens in the diet
    • INSL3 production

Source: Amory (2007) J Andrology E-pub ahead of print.

mhcs side effects
MHCs – Side effects
  • Similar to side effects experienced by women on hormonal contraceptives
  • Mild weight gain, increase in lean muscle mass, acne
  • Drop in HDL cholesterol level with some androgens
  • No prostate over-stimulation observed in studies up to 18 months
mhcs how are they reversed
MHCs – How are they reversed?
  • Stop treatment, hormones begin rebound, spermatogenesis reinitiates
  • Meta analysis showed all formulations reliably reversible within 3-5 months
  • Minimum 2½ month recovery due to lag for production of mature sperm

Source: Liu (2006) The Lancet 367: 1412–20.

interesting leads adjudin
Interesting leads - Adjudin
  • Non-toxic lonidamine analog
  • Disrupts cellular bridges between spermatids and Sertoli cells
  • Clever targeted delivery by attaching Adjudin to a modified FSH
  • Population Council researchers working to improve delivery method and bring down production costs

Source: Mruk (2006) Nature Medicine 12(11):1323-8.

interesting leads rar antagonist
Interesting leads – RAR antagonist
  • Retinoic acid required for sperm production
  • 1 week of RAR antagonist treatment blocks sperm production for 3 months
  • 100% effective, no observable side effects, fully reversible
  • Researchers at Columbia University testing in other animal models

Source: Wolgemuth (2007) Future of Male Contraception abstract.

in summary
In summary
  • Men & women are ready for better options
  • Promising products in the pipeline
  • Investment in contraceptive technologies should remain part of the reproductive health agenda
for more information
For more information
  • Explanations of emerging male contraceptives MaleContraceptives.org
  • Research community forumIMCCoalition.org
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