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HORMONAL CONTRACEPTIVES- NEW DELIVERY SYSTEMS

HORMONAL CONTRACEPTIVES- NEW DELIVERY SYSTEMS. DR. RITU JOSHI CHAIR-PERSON FAMILY WELFARE COM. FOGSI. INTRODUCTION. -India still has a major unmet need for contraception and newer methods in the cafeteria approach should be made available.

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HORMONAL CONTRACEPTIVES- NEW DELIVERY SYSTEMS

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  1. HORMONAL CONTRACEPTIVES- NEW DELIVERY SYSTEMS DR. RITU JOSHI CHAIR-PERSON FAMILY WELFARE COM. FOGSI

  2. INTRODUCTION -India still has a major unmet need for contraception and newer methods in the cafeteria approach should be made available. -Ongoing research is leading to improved types of contraceptive hormones, reduced dosage and the development of innovative new methods of delivery.

  3. NEWER DELIVERY SYSTEMS Criteria:- - Should be more effective - Fewer side-effects - Less costly to manufacture - Easier to deliver than current options

  4. Available Or Underdevelopment Are:- A. Vaginal Rings 1. Combined vaginal ring 2. Progestin-only ring B. Transdermal 1. Patch 2. Spray-on 3. Gel

  5. VAGINAL CONTRACEPTIVE RING Vaginal ring is a method developed to administer contraceptive steroids. Weisberg et at. 1999 Two Types:- 1. Combined estrogen and progestin vaginal ring 2. Progestin-only vaginal ring

  6. HISTORY - First hormone-containing rings were described in 1970. - Mishell e al. 1970 - Initially,high doses of progestogens with androgenicity resulted in unacceptable effect on lipo-proteins. - Low dose progestogen-only ring were associated with unpredictable bleeding patterns. - Mishell et al. 1978 • Later, development of combined contraceptive vaginal rings. Produced good cycle control and suppressed ovulation but were associated with high levels nausea and problems with steroid release. - Ballagh et al. 1994 • In 1980s Organon began development of Nuva ring with a multi-compartment ring, where release rates of estrogen and progestogen were individually specified.

  7. 4 mm 54 mm NUVARING Is a novel method of contraception. • Permits vaginal delivery of FDA-approved contraceptive hormones. • Is a flexible, soft transparent ring made of ethylene vinyl acetate (EVA) with outer diameter of 54mm and cross-section diameter of 4mm. • Each ring contains 2.7mg Ethinyl estradiol and 11.7mg Etonogestral uniformly dispersed within the EVA core. - NuvaRing releases 15ug EE and 120ug ENG per day.

  8. ADMINISTRATION - Inserted and removed by women herself. - Position of insertion- Any position which allows her to insert ring easily- squatting, lying or standing with one leg raised. - Time of insertion- Begin ring use when pregnancy can be excluded. Any day between days 1 and 5 of menstrual periods. - Ring is worn for 3 weeks, then discarded. - A new rig is inserted one week later for a 28-day cycle.

  9. Vaginal Contraceptive Ring: Insertion There is no wrong way to insert the ring. If it lies comfortably in the vagina, it has been placed correctly.

  10. Dosing Schedule Each NuvaRing is inserted for one cycle of use; one cycle comprises of 3 weeks of ring followed by a 1-week ring free period. Removal Of Ring - Removed after 3 weeks, on the same day it was inserted. - Method of removal- . By hooking the index finger under the rim. . Or by grasping the rim with middle and index finger and gently pulling it out.

  11. Mechanism Of Action 1. Completely inhibits ovulation. 2. Atrophic endometrial changes. 3. Thickening of cervical mucus. Acceptability - Highly acceptable - At baseline 66% of women found the ring acceptable, 81% after 3 months of use.

  12. WHY VAGINAL CONTRACEPTION? - User control easily inserted and removed - A MONTHLY METHOD No need for daily attention - Continuous release with constant serum hormone levels - Lowest ethinyl estradiol dose - Avoids gastro-intestinal interference with absorption - Avoids hepatic first-pass metabolism of the progestin - No significant difference in most estimated genital symptoms compared to oral contraception. .More reported vaginal wetness .Larger number of lactobacillus colonies present were positive for hydrogen peroxide production. Veres S, Miller L, Burington B. Obstet Gynecol.2004;104:555-63

  13. Ovulation Inhibition Summary • NuvaRing completely inhibits ovulation during recommended and extended use up to 28 days. • For 14 of 16 women, the largest follicles and the highest estradiol levels occurred during the first week of use. • Concentrations of follicle-stimulating hormone were low. • No surge in luteinizing hormone was detected. • Progestrone levels were low(<2.9nmol/l). • Rapid return to ovulation after ceasing use. Mulders TM, Dieben TO,. Fertil Steril. 2001;75:865-870.

  14. Contraceptive Ring Efficacy Dieben TO, et al. Obstet Gynecol. 2002;100:585-593.

  15. Incidence Of Withdrawal Bleeding • With bleeding occurred in 98.5% of cycles . Early withdrawal- 6.1% of all cycles . Late withdrawal-23.9% of all cycles • Mean duration of withdrawal bleeding ranged from 4.5 to 5.2 days (European and United States experience) • Bleeding began on day 3(interquartile range 2-4) Dieben TO, et al. Obstet Gynecol. 2002;100:585-93

  16. Adverse Effects 1. Vaginitis 2. Leucorrhoea 3. Headache 4. Expulsion

  17. What To Do If The Vaginal Ring……….? …..Slips out or is left out .within three hours, rinse and reinsert .after three hours, rinse, reinsert AND use a back-up contraceptive for one week …..Is not replaced at day 8 .consider emergency contraception .rule out pregnancy .insert new ring .Use a back-up contraceptive for one week

  18. SUMMARY • Safe and effective • Monthly method for better compliance • Well tolerated • User controlled

  19. Transdermal Contraception Introduction Works transdermally by slowly releasing a combination of progestin and estrogen through skin. Types:- 1. Patch 2. Spray-on 3. Gel

  20. Transdermal contraceptive Patch Introduction • Is the first transdermal system of a combined contraceptive approved by US-FDA (Ortho-Evra). - Has a contact surface area of 20 sq cm and measuring 4.5sq cm. - Contains 6.00mg norelgestromin [NGMN] and 0.75mg ethinyl estradiol [EE]. - Delivers continuous systemic dosage of 150ug NGMN and 20ug of EE per day. - Therapeutic contraceptive levels are reached rapidly, peaking 48 hrs after patch placement. - Weekly[7-day] delivery and dosage. - By -passes the gastro-intestinal tract.

  21. Description Is a thin, matrix-type transdermal contraceptive patch consisting of- 1. The backing layer- Composed of a beige flexible film. Provides structural support and protects the middle adhesive layer from the environment. 2. The middle layer- Active components in this layer are the hormones, NGMN and EE. 3. The third layer is the release liner. Protects the adhesive layer during storage and is removed just prior to application.

  22. Sites Of Application - Buttocks - Upper outer arm - Back - Lower abdomen or - Upper torso (excluding breast)

  23. 3-patch system Apply 1 patch each week for 3 weeks Apply each patch the same day of the week 1 week is patch-free Patch #1 Patch #2 Patch #3 Patch-free Start next cycle 28-day cycle 28-day cycle Week 5 Week 1 Week 2 Week 3 Week 4 Transdermal Contraceptive System: Description Abrams LS, et al. J Clin Pharmacol. 2001;41:1232-1237, 1301-1309; Abrams LS, et al. Contraception. 2001;64:287-294; Creasy GW, et al. Semin Reprod Med. 2001;19:373-380; Audet MC, et al. JAMA. 2001;285:2347-2354; Smallwood GH, et al. Obstet Gynecol. 2001;98:799-805.

  24. Advantages • Weekly application encourages compliance. • Easy verification of presence reassures user of continued protection. • Does not require vaginal insertion. • Contraceptive effects are rapidly reversible. - Excellent cycle control after three months.

  25. Disadvantages - Application site reaction. - Not as effective in women more than 198 pounds. - Side-effects similar to oral contraceptives except for- .High rates of breast pain during first two months. .Higher rates of dysmenorrhoea. - May be difficult to conceal. - No protection against HIV or other sexually transmitted diseases. Zeiman M, et al. Fertil Steril,2002;77(suppl)513-18

  26. Transdermal Contraceptive Patch: Pooled Analysis of EfficacyThrough 13 Cycles *Kaplan-Meier estimates of the cumulative probabilities of pregnancy. Zieman M, et al. Fertil Steril. 2002;77(Suppl 2):S13-S18; Smallwood GH, et al. Obstet Gynecol. 2001;98(Pt 1):799-805; Audet MC, et al. JAMA. 2001;285:2347-2354; Hedon B, et al. Int J Gynaecol Obstet. 2000:70(suppl 1):78.

  27. Transdermal Contraceptive Patch: Most Common Adverse Events *Reported only during the first 2 study cycles. Audet MC, et al. JAMA. 2001;285:2347-2354.

  28. Transdermal Contraceptive Patch: Replacement Because of Partial or Complete Detachment* *Patients randomized to treatment with the patch received 3 replacement patches at the beginning of the study. Audet MC, et al. JAMA. 2001;285:2347-2354.

  29. Patient Counseling on Usage and Disposal • Application: . Use a new location for each patch . Apply to clean, dry skin . Apply where it won’t be rubbed by clothing: buttocks, abdomen, upper arm, upper torso . Do not use on irritated or abraded skin . Do not use on breasts . Avoid oils, creams, or cosmetics until after patch placement . Bathe and swim as usual • Anticipate more breast discomfort during first 2 months • Store at room temperature • Do not cut, alter or damage the patch as it may alter contraceptive efficacy • Do not flush a used patch into the water system; fold the used patch in half and place in the trash

  30. Patient Counseling on Basic Instructions • If switching from an oral contraceptive, apply the patch as soon as withdrawal bleedings (Day 1 start) - Sunday start: use backup protection for 7 days unless Sunday is the first day of the menstrual cycle. • Wear each patch for 7 days; subsequent patch changes are made on the same day of the week • No more than 7 days should lapse between the application of the last patch of the prior 21-day cycle and the first patch of the next 21-day cycle • For partial or full detachment, make sure the exposed undersurface of the patch is clean and adherent; press it into place for 10 seconds; if the patch does not adhere completely, remove it and replace it with another patch.

  31. Transdermal Contraceptive Patch:Managing Missed or Late Applications 28-Day Cycle (Days 1-28) Next 28-Day Cycle (Days 29-56) Patch #2 Days 8-15 Patch #1 Days 1-7 Patch #3 Days 16-21 No Patch Patch #1 • This patch was not removed: • Remove immediately • Start cycle on day 29 • Patch application is 1 to 2 days late: • Apply new patch immediately; Make this the new “patch change day” • No backup protection is required • Patch application is >2 days late: • Immediately start new 21-day application cycle • Use backup protection for 7 days • Consider emergency contraception • This patch was not applied: • Apply a new patch immediately; this is the new “patch change day” • Use backup protection for 7 days • Consider emergency contraception

  32. CONCLUSION • The contraceptive patch is a unique transdermal contraceptive device. • It is US-FDA approved. • Consecutive applications of 3 patches for 7 days each, followed by a 7-day patch free phase. • Efficacy- . Greater compliance among users when compared with the users of oral contraceptives. . Not as effective in women weighing >198 pounds.

  33. Spray-On Contraceptive • The progestin Nestorone, appropriate for breastfeeding women, can be delivered through a spray or gel also. • Phase 1 clinical trials of Nesterone Metered Dose Transdermal System, a daily progestin-only spray-on contraceptive began in Australia in 2004. • Spray-on approach is a new technique for transferring a preset dose of fast-drying hormones onto the skin. • Spray is absorbed instantaneously. - Hormone collects as a reservoir with in the skin from which it then slowly diffuses into the blood stream.

  34. Contraceptive Gel Clinical trial of Nestorone gel is applied to the skin daily for 3 months, suppressed ovulation in 83% of participants.

  35. Thanks to all contributors. Dr Adarsh Bhargava. Dr Ashwini Bhalerao. Dr Alka Kriplani. Dr. Kalpana Apte. Dr Mala Arora. Dr.Meenakshi Bharath. Dr. Mandakini Parihar. Dr.Nozer Sheriar. Dr.Parikshit Tank. Dr. Roza Olyai. Dr.Sasikala Kola. Dr.Sujata Mishra.

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