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The Future of Contraception

The Future of Contraception. The Future of Contraception. Impact of Generics Review of new methods Current In clinical trial or development Contraception OTC. The Impact of Generics. Generics What can be Patented?. The chemical The combination (dose) Administration regimen. Generics.

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The Future of Contraception

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  1. The FutureofContraception

  2. The Future of Contraception • Impact of Generics • Review of new methods • Current • In clinical trial or development • Contraception OTC

  3. The ImpactofGenerics

  4. GenericsWhat can be Patented? • The chemical • The combination (dose) • Administration regimen

  5. Generics • All current estrogens are off patent • Drospirenone is still on patent (Yasmin, YAZ) • New OCPs using other progestins = different doses or different administration regimens

  6. New OCPsExtended or No Cycle Seasonale 84/7 (150 g levonorgestrel + 30 g EE Seasonique 84/7 (Seasonale but 7 = 10 g EE) Lybrel continuous (90 g levonorgestrel + 20 g EE) Generic

  7. New OCPsExtended Cycle 24/4 LoEstrin 24 YAZ

  8. Extended-Cycle OC Trial: Regimens Regimens Formulation 150 g levonorgestrel/30 g ethinyl estradiol (SEASONALE) 150 g levonorgestrel/30 g ethinyl estradiol (Nordette) 100 g levonorgestrel/20 g ethinyl estradiol (SEASONALE Ultra-Lo) 100 g levonorgestrel/20 g ethinyl estradiol (Levlite) Extended 84/7 Conventional 21/7 Extended 84/7 Conventional 21/7 Anderson FD. Obstet Gynecol 2002;99(suppl)265; Poster presented at ACOG 50th Annual Clinical Meeting; May 4-8, 2002; Los Angeles, CA

  9. Extended-Cycle OC Trial: Summary • 91-day extended-cycle OC regimen is as effective a contraceptive as 28-day OC (>99% with perfect use); typical use efficacy lower than class labeling • Produces 4 cycles per year compared with 13 with 28-day cycle OC • Breakthrough bleeding comparable to 28-day cycle OC, especially by 3rd and 4th 91-day cycle

  10. Lybrel • 90 g levonorgestrel • 20 g ethinyl estradiol Take 1 pill every day No pill free interval Package insert

  11. Lybrel Efficacy comparable to standard OCPs

  12. Lybrel Month 6 48% no bleeding Month 12 59% no bleeding 20% spotting (no protection) Package insert

  13. Recently Approved 24/4 OCs

  14. Recently Approved 24-DayOral Contraceptive Regimens • Loestrin® 24 Fe(norethindrone acetate 1 mg/EE 20 mcg) • YAZ® (drospirenone 3 mg/EE 20 mcg) • Each has a dosing regimen of 24 active days of hormones followed by 4 hormone-free days Loestrin® [package insert]. Rockaway, NJ: Warner Chilcott Company, Inc.; February 2006. Available at: http://www.loestrin24.com/pdf/pi_loestrin24_fe.pdf. YAZ® [package insert]. Montville, NJ; Berlex Inc.; December 2006. Available at: http://www.berlex.com/html/products/pi/fhc/YAZ_PPI.pdf

  15. Loestrin 24 Fe Efficacy • Norethindrone acetate 1 mg/EE 20 g • Comparative study of 24/4 vs 21/7 of same combination • 24/4 21/7 • Pearl Index 1.82 2.98 NakasimaST, Archer DF, Ellman H. Contraception 2007; 75(1):16

  16. YAZ Efficacy • Drospiranone 3 mg/EE 20 g • Non-comparative study • 11 pregnancies in 11,140 cycles • Pearl index: 1.29 • - Comparable to other OCs Bachmann et al. Contraception 2004; 70:190

  17. The Newest Implantable: A Single Rod • Etonogestrel subdermal implant 68 mg

  18. Design of ENG Rod 40 mm 2 mm Core: 40% Ethylene vinyl acetate (EVA) 60% Etonogestrel (68 mg) Rate-controlling membrane: (0.06 mm) 100% EVA

  19. ENG Rod Pharmacokinetics 400 300 200 Etonogestrel (pg/ml) 100 Inhibits ovulation (90 pg/ml) • 2 1 3 30 120 210 360 Days After Insertion Davies GC, et al. Contraception. 1993;47:251–261.

  20. Contraceptive Efficacy of ENG Rod Women 2362 Cycles 73,429 Pregnancies 0 Pearl Index (95% CI) 0-0.09 Glasier A. Contraception. 2002;65:29–37.

  21. Implant Insertion and Removal Time (Minutes)* ENG Rod LNG Implant N Mean SD Min-max 670 1.1 0.9 0.03–5.0 665 4.3 2.1 0.83–18.0 Insertion N Mean SD Min-max 633 2.6 2.0 0.2–20.0 137 10.2 8.2 1.3–50.0 Removal *Insertion time = time needed for incision (if any) and placement; removal time = time needed for anesthesia, incision, and removal. Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5(suppl 2):29–34.

  22. Bone Mineral Density and ENG Rod • Head-to-head study of ENG rod with non-medicated IUD (copper) • No differences in BMD changes between 2 groups • Authors concluded that although ENG rod is a progestin-only method, no bone loss occurs during use Beerthuizen R, et al. Hum Reprod. 2000;15:118–122.

  23. Vaginal Ring Etonogestrel/Ethinyl Estradiol Vaginal Ring

  24. Etonogestrel/Ethinyl Estradiol Vaginal Ring Progestin: Etonogestrel: 120 µg/day Estrogen: Ethinyl estradiol: 15 µg/day • Worn for three out of four weeks • Self insertion & removal • Pregnancy rate 0.65 per 100 woman–years Roumen FJ, et al. Hum Reprod. 2001;16(3):469-475.

  25. Vaginal Ring Patient Management • Patient inserts ring and it is supposed to remain in the vagina for 3 weeks • Ring is removed during the fourth week, menstrual period should begin • If ring is removed or slips out of place for > 3 hrs, back-up contraception is necessary for 7 days

  26. Vaginal Ring Summary • Good cycle control • Irregular bleeding was rare (2.6% - 6.4% of evaluable cycles) • Withdrawal bleeding occurred (97.9% - 99.4% of evaluable cycles) • Compliance with the regimen was met in 90.8% of cycles Roumen FJ, et al. Hum Reprod. 2001;16(3):469-475.

  27. Contraceptive Patch Application of the Transdermal Patch on Abdomen

  28. Contraceptive Patch Equivalence of Sites: EE Results 100 75 Abdomen Arm EE Serum Concentration (pg/mL) 50 Buttock Torso 25 0 0 1 2 3 4 5 10 6 7 8 9 Days Skee D, et al. Clin Pharm Ther. 2000;67:159.

  29. Contraceptive Patch NGMN and EE LevelsPatch vs OC* 150 2.1 Patch EE Patch NGMN 125 1.8 EE NGMN 100 1.5 Reference Range EE Serum Concentration (pg/mL) NGMN Serum Concentration (ng/mL) 75 1.2 Patch Removed .9 50 25 .6 0 .3 0 1 2 3 4 5 6 7 8 9 10 11 12 Days *Noncomparative data Abrams L, et al. Contraception. 2001;64:287-294.

  30. Contraceptive Patch Comparative Randomized, Controlled Trial Data: Efficacy(pregnancies per 100 woman-years) Pearl Indices Method Pearl** Cycles (n) Pregnancies (n) Overall Pearl* 0.99 5240 5 1.24 Patch OC 1.25 4167 7 2.18 *User failure plus method failure **Failure when taken as directed Audet M, et al. JAMA. 2001;285:2347-2354.

  31. Contraceptive Patch Mean Proportion of Participants’ Cycles With Perfect Compliance *(p<.001) Audet M, et al. JAMA. 2001;285:2347-2354.

  32. Contraceptive Patch Compliance by Age Group % Compliant Cycles P<0.001 P<0.001 P<0.001 P<0.008 P<0.006 P<0.005 Age (years) Archer D, et al. Fertil Steril. 2001;76:S20. Abstract O-50.

  33. Distribution of Pregnancies by Baseline Body Weight Deciles (n=3319 subjects) Decile Weight Pregnancies Range (kg) Total 1 <52 1 2 52 - <55 2 3 55 - <58 0 4 58 - <60 0 5 60 - <63 2 6 63 - <66 0 7 66 - <69 1 8 69 - <74 0 9 74 - <80 2 10 80 7 80 - 85 1 85 – 90 1 > 90 5 Zieman et al., Fertil Steril 2001; vol. 76:S19 (abst O-48)

  34. Contraceptive Patch Comparative Data: Most Common Adverse Events Audet M, et al. JAMA. 2001;285:2347-2354.

  35. IUDs • Have low increased risk of infection • Are not major or independent cause of PID • Do not increase risk of ectopic pregnancy • Do not cause infertility after removed • Are NOT abortifacients

  36. Mirena® • Releases 20 µg/day of LNG in vitro for the first year and about half that amount by the fifth year of use • Long-term reversible method • Early spotting, anemia • Reduction in menstrual blood loss • Low systemic levels of LNG Steroidreservoir Steroidreservoir 32mm 32 mm Levonorgestrel 20 mcg/day Levonorgestrel 20 mcg/day MIRENA® Package Insert. MIRENA® Package Insert.

  37. Intrauterine System Levonorgestrel IUS: Efficacy • Overall failure rate 0.1 per 100 women • Gross cumulative five-year failure rate is 0.7 per 100 women Luukkainen T, et al. Contraception. 1987;36:169-179. Mirena Package Insert.

  38. IUD • Use by nulliparous women now allowed • History of PID no longer a contraindication • Woman must be in a “stable” (rather than “mutually monogamous”) relationship Labeling change for CuT 380A (2005)

  39. Essure® • Soft, flexible micro-insert • The Essure procedure is performed by a trained gynecologist and is an alternative to surgical sterilization • Essure is 99.8% effective in preventing pregnancy • Another method of birth control must be used for at least three months after the procedure Uterus Cervix ESSURE® Package Insert.

  40. Pop Council Ring • Nestorone / Ethynyl Estradiol • Wear for 3 weeks • Remove for 1 week • Reinsert (13 cycles)

  41. Hormone % Azospermic Waites, GMH. British Medical Bulletin1993;49:210-221

  42. Frequency of Use Daily or with Intercourse 1 wk – 1 mo 3 mos. + Oral Contraceptives Patch DMPA Barrier Injectable Implant Spermicide Vaginal Ring IUS Combination of estrogen and progestin Effective, Reversible, Safe Contraceptives

  43. Overview Comparison of New Contraceptive Methods

  44. Contraception OTC Emergency Contraception

  45. HollyMead, Institute for Women’s Policy Research. Publication # A126, 2001.

  46. HollyMead, Institute for Women’s Policy Research. Publication # A126, 2001.

  47. HollyMead, Institute for Women’s Policy Research. Publication # A126, 2001.

  48. HollyMead, Institute for Women’s Policy Research. Publication # A126, 2001.

  49. HollyMead, Institute for Women’s Policy Research. Publication # A126, 2001.

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