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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

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New Contraceptives for Men

SWEET SeminarDecember 2007

Kirsten Thompson, DirectorMale Contraception [email protected]


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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


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What is a contraceptive?

  • Is contraception inherently inconvenient?

  • What doesn’t a contraceptive do?


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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


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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?”


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Do men want new options?

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

Source: CDC (2006) Health, United States


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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.


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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.


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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


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Vas-based methods


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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


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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.


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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.


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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.


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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


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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


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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.


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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.


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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


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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


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MHCs – Formulations

T-only formulations are more effective for Asian men


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MHCs – Formulations

T + progestin formulations effective for all


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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.


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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.


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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


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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.


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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.


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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.


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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


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For more information

  • Explanations of emerging male contraceptives MaleContraceptives.org

  • Research community forumIMCCoalition.org


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