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

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Presentation on theme: "The Future of Contraception. Impact of Generics Review of new methods –Current –In clinical trial or development Contraception OTC."— Presentation transcript:

1 The Future of Contraception

2 Impact of Generics Review of new methods –Current –In clinical trial or development Contraception OTC

3 The Impact of Generics

4 Generics What can be Patented? 1.The chemical 2.The combination (dose) 3.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 OCPs Extended or No Cycle Seasonale84/7(150 g levonorgestrel + 30 g EE Seasonique84/7(Seasonale but 7 = 10 g EE) Lybrel continuous(90 g levonorgestrel + 20 g EE) Generic

7 New OCPs Extended Cycle 24/4 LoEstrin 24 YAZ

8 Extended-Cycle OC Trial: Regimens Extended 84/7 Conventional 21/7 Extended 84/7 Conventional 21/7 150 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 ) RegimensFormulation Anderson FD. Obstet Gynecol 2002;99(suppl)265; Poster presented at ACOG 50th Annual Clinical Meeting; May 4-8, 2002; Los Angeles, CA

9 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 Extended-Cycle OC Trial: Summary

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 648% no bleeding Month 1259% no bleeding 20% spotting (no protection) Package insert

13 Recently Approved 24/4 OCs

14 Recently Approved 24-Day Oral 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: YAZ ® [package insert]. Montville, NJ; Berlex Inc.; December 2006. Available at:

15 Loestrin 24 Fe Efficacy Norethindrone acetate 1 mg/EE 20 g Comparative study of 24/4 vs 21/7 of same combination 24/421/7 Pearl Index 1.822.98 Nakasima ST, 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 Rate-controlling membrane: (0.06 mm) 100% EVA 40 mm 2 mm Core:40% Ethylene vinyl acetate (EVA) 60% Etonogestrel (68 mg)

19 Davies GC, et al. Contraception. 1993;47:251–261. 400 1 2 330120210360 100 200 300 Days After Insertion Etonogestrel (pg/ml) Inhibits ovulation (90 pg/ml) ENG Rod Pharmacokinetics

20 Contraceptive Efficacy of ENG Rod Women2362 Cycles73,429 Pregnancies0 Pearl Index (95% CI)0-0.09 Glasier A. Contraception. 2002;65:29–37.

21 Implant Insertion and Removal Time (Minutes)* Insertion Removal N Mean SD Min-max N Mean SD Min-max 670 1.1 0.9 0.03–5.0 633 2.6 2.0 0.2–20.0 665 4.3 2.1 0.83–18.0 137 10.2 8.2 1.3–50.0 ENG ENG Rod LNG LNG Implant *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 Etonogestrel/Ethinyl Estradiol Vaginal Ring 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 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 Vaginal Ring

26 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. Vaginal Ring

27 Application of the Transdermal Patch on Abdomen Contraceptive Patch

28 100 10 789 012345 6 0 25 50 75 Abdomen Arm Buttock Torso Equivalence of Sites: EE Results EE Serum Concentration (pg/mL) Days Contraceptive Patch Skee D, et al. Clin Pharm Ther. 2000;67:159.

29 Days EE Serum Concentration (pg/mL) 2.1 1.8 1.5 150 125 100 75 50 25 NGMN Serum Concentration (ng/mL).30 0123456789101112 Patch EE Patch NGMN EE NGMN Patch Removed Reference Range NGMN and EE Levels Patch vs OC* *Noncomparative data Abrams L, et al. Contraception. 2001;64:287-294. Contraceptive Patch

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

31 Mean Proportion of Participants Cycles With Perfect Compliance NTotal Cycles% of Cycles Patch811514188.2* OC605413477.7 *(p<.001) Audet M, et al. JAMA. 2001;285:2347-2354. Contraceptive Patch

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

33 Distribution of Pregnancies by Baseline Body Weight Deciles (n=3319 subjects) DecileWeight PregnanciesRange (kg) Total 1<521 252 - <552 3 55 - <580 4 58 - <600 5 60 - <632 6 63 - <660 7 66 - <691 8 69 - <740 9 74 - <802 10 807 80 - 851 85 – 901 > 905 Zieman et al., Fertil Steril 2001; vol. 76:S19 (abst O-48)

34 Comparative Data: Most Common Adverse Events Patch (N=812)OC (N=605) Overall Treatment Limiting Overall Treatment Limiting Breast discomfort19%1.0%6%0.2% Headache22%1.5%22%0.3% Application site reaction 20%2.6%NA Nausea20%1.8%18%0.8% Abdominal pain8%0.2%8%0.3% Dysmenorrhea13%1.5%10%0.2% Audet M, et al. JAMA. 2001;285:2347-2354. Contraceptive Patch

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 ® MIRENA ® Package Insert. Levonorgestrel 20 mcg/day Steroid reservoir 32 mm 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 MIRENA ® Package Insert. Levonorgestrel 20 mcg/day Steroid reservoir 32 mm

37 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. Intrauterine System

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 ESSURE ® Package Insert. Uterus Cervix

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


42 AsianCaucasian TE9160 TE + DMPA9659 19NT + DMPA9867 Waites, GMH. British Medical Bulletin 1993;49:210-221 Hormone% Azospermic

43 Effective, Reversible, Safe Contraceptives IUSVaginal RingSpermicide ImplantInjectableBarrier DMPAPatchOral Contraceptives 3 mos. +1 wk – 1 mo Daily or with Intercourse Frequency of Use Combination of estrogen and progestin

44 Comparison of New Contraceptive Methods Monthly Injectable ImplantIUSRingPatch EfficaciousYes Office visits1 Month Insertion & removal Prescription Easily reversible Yes Dosing frequency 1 month3-5 yrs5 yrs Every 4 weeks Weekly User- controlled No Yes DiscreetYesSometimesYes Sometimes Overview

45 Contraception OTC Emergency Contraception

46 HollyMead, Institute for Womens Policy Research. Publication # A126, 2001.






52 What Happens to My Agency Pt volume Cost of OTC items Focus on provider assisted methods: IUC, Implant, Injection ? Ring and Patch

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