Zeev Harel, MD Associate Professor of Pediatrics Hasbro Children’s Hospital and

1. “New Hormonal Contraceptive Options For The Sexually Active Adolescent” • Zeev Harel, MD • Associate Professor of Pediatrics • Hasbro Children’s Hospital and • Brown Medical School, Providence, RI

2. Teenage Pregnancy Rate 1,000,000/year 980,000/year

3. Decrease in teenage pregnancy rate The availability of a variety of contraceptive methods increases the likelihood of successful contraception More adolescents abstain or postpone sexual activity

4. Prevention of Teenage Pregnancy While programs working towards abstinence or postponing sexual activity are extremely important, it is also essential that adolescents who do become sexually active receive the proper contraceptive method.

5. Contraception Barrier Methods Hormonal Methods Short Acting Long Acting Physical Barriers Chemical Barriers • Male condom • Female • condom • Diaphragm • Cervical Cap • IUD • Sponge • Spermicides • (Nonoxynol 9) • Gel • Foam • Cream • Film • Suppository • Sponge • OCP • Injection • Implants • IUS • Transdermal • Patch • Vaginal ring

6. Interception Morning after pills (emergency contraception)

7. Condoms Despite all the efforts, consistent condom use among adolescents is only around 30%

8. CondomsCare Provider's Role • Advocate consistent condom use • Go into specific details and be prepared to provide information regarding various condoms

9. Condoms The message being not to give up on condom use, but to try different brands until the adolescent finds a condom that he or she is satisfied with.

10. Condoms Dislike of one brand of latex condom Try a different brand of latex condom

11. Condoms Dislikes latex condoms or is allergic to latex Try a condom made of polyurethane

12. Condoms Made of Polyurethane Avanti  Trojan Supra  Male condoms Reality  The female condom

13. The Polyurethane Condom (Avanti ) Advantages • May be used by patients with latex allergy • Stronger, resists oil-based lubricants • Transparent, odorless, thinner than latex • May fit less restrictively than latex condom

14. The Polyurethane Condom (Avanti ) Disadvantages • Higher frequency of slippage and breakage • Costs more

15. Female Polyurethane Condom"Reality" in Adolescents • The majority of users rated it as an "acceptable" barrier method • Female condom users reported comfort using vaginal products and were more likely to have used a vaginal douche • The high rate of STD reported among girls who were given female condoms and educational materials indicated inconsistent use of this method

16. Oral Contraceptive Pills (OCP) EstrogenDoseEvolution 1960 Mestranol 150 mcg (105 mcg ethinyl estradiol) Present Ethinyl Estradiol 20-25-35 mcg

17. Oral Contraceptive Pills (OCP) Estrogen related side effects • Nausea • Breast tenderness/swelling • Fluid retention • Headache • Heavy menstrual bleeding

18. Less Estrogen Related Side Effects Ethinyl Estradiol 35mcg 25mcg 20mcg Better Cycle Control

19. Oral Contraceptive Pills (OCP) ProgestinEvolution • Dose reduction • -From 10 mg (1960) to 0.15-1 mg • -Phasic regimens • Development of more selective • (less androgenic) agents • -Norgestimate • -Desogestrel • -Drospirenone

20. Oral Contraceptive Pills (OCP) Progestin related side effects • Weight gain • Acne • Hair growth

21. New Oral Contraceptive Pills: Cycle Control • Cyclessa: triphasic desogestrel / • EE 25 mcg • Ortho Tri-Cyclen Lo: triphasic norgestimate / • EE 25 mcg •  • High rate (97%) of scheduled menstrual bleeding • Low rate (10%) of intermenstrual (breakthrough) bleeding and spotting

22. New Oral Contraceptive Pills (OCP) Yasmin (Ethyinylestradiol30 mcg / Drospirenone 3 mg) • Approved by the FDA in May 2001 • Progestine (drospirenone) - a spironolactone analogue with antimineralocorticoid and antiandrogenic activity (similar to 25 mg dose of spironolactone) • Adolescents with acne and hirsutism may benefit from its use • Potassium levels should be examined periodically

23. New Oral Contraceptive Pills (OCP) YASMIN Additional Contraindications / Warnings • Contraindicated to use in patients with conditions that predispose to hyperkalemia (renal insufficiency, hepatic dysfunction, adrenal insufficiency) • Patients on medications that may increase serum potassium (ACE inhibitors, Angiotensin-II receptor antagonists, potassium-sparing diuretics, heparin, Aldosterone antagonists, and NSAIDs) should have their serum potassium level checked during the first cycle.

24. OCP Careprovider's responsibilities • Address misperceptions • Review for contraindications • Tailor the appropriate OCP for the patient • Provide counseling before use and during use, and immediately address any concern or problem associated with the use of OCP

25. Misperceptions About OCP 2000 ACOG Gallup Poll • 41% of women believe OCP carry substantial health risks • Among these women, the most common (16%) health risk believed to be associated with OCP use was cancer • Only 8% of women were aware that OCP might reduce the risk of ovarian and endometrial cancers

26. *The risks of malignancies with the new methods (patch, ring) are unknown. OCP (combined estrogen progestin) Depo-Provera (progestin only () slightly (promotional effect, localized disease) Breast Cancer no change Endometrial Cancer () risk () risk () risk Ovarian Cancer no change () risk in women with HPV infection Cervical Cancer no change () risk Colorectal Cancer

27. OCPCardiovascular Risk • No increase in risk in healthy, non-smoking women • () risk with smoking and hypertension • Risk of thromboembolism among OCP users is 3-4 times greater than the risk in women not using OCP but is far less than that associated with pregnancy

28. WHO Medical Eligibility Criteria for OCP (First edition-1996, Second edition-2000) • No restriction • Benefits > risks (generally use the method) • Risks > benefits (not usually recommended) • Use unacceptable

29. Review for Contraindications: Coagulation System Abnormalities Ask about family history of: Factor V Leiden Mutation (Resistance to Protein C) Protein C Protein S  Antithrombin III Hx of DVT (4) Hx of superficial thrombophlebitis (2)

30. Review for Contraindications: Breast Disease • Breast cancer (4) • Benign breast disease (1) • Family history of breast disease (1)

31. Review for Contraindications: Liver Disease • Liver tumors (benign/malignant) (4) • Acute liver disease (4)

32. Review for Contraindications: Hypertension • Hypertension (4) • Adequately controlled hypertension (3) • History of high blood pressure during pregnancy (2)

33. Review for Contraindications: Headaches • Migraines without focal neurologic symptoms (2) • Migraines with focal neurologic symptoms (4)

34. Review for Contraindications: Chronic Disease / Diabetes • No vascular complications - 2 • Nephropathy - 3/4 • Retinopathy - 3/4 • Neuropathy - 3/4

35. Oral Contraceptive Pills (OCP) • 21-pill pack versus 28-pill pack • (Be specific when you write a prescription) • Mini pills (progestin only) versus combined • (estrogen/progestin) pills • Monophasic (constant amount) versus • multiphasic (amount varies) • Estrogen/progestin components

36. Oral Contraceptive Pills: Estrogen Component • Ethinyl estradiol: 20-50 micrograms • Mestranol: 50 micrograms (less used, • must undergo O-demethylation in the liver)

37. Oral Contraceptive Pills: Progestin Component • Various progestins • Various amounts • Various metabolites

38. OCP- Progestin Role • To help in blocking ovulation • To counteract some of the • estrogenic effects

39. Oral Contraceptive Pills: Progestin Potency • Affinity for progesterone receptors • Affinity for androgen receptors • Effect on sex hormone binding globulin (SHBG)

40. Tailoring OCP Girls with no problems Low Dose OCP Monophasic Triphasic

41. Tailoring OCP Prescribe OCP with a potent progestin (such as norgestrel or levonorgestrel) to: Girls with • heavy menstrual bleeding • severe dysmenorrhea • signs of fluid retention (bloating) • breast tenderness

42. Tailoring OCP Prescribe OCP with a less androgenic progestin (such as norgestimate, desogestrel, or drospirenone) to: Girls with • acne • hirsutism • PCO • overweight

43. OCP-Counseling • Address safety issues, perceived health risks • Emphasize benefits of OCP (regular periods, • relief of dysmenorrhea, improved acne) • Review side effects (breakthrough bleeding • and nausea are common during the first 3 cycles) • Advise patient to take the pill at bed time after • brushing teeth

44. OCP-Counseling (continued) • Emphasize the need for consistent • use of condoms • Open-door, open-telephone policy • (encourage patient to contact you with any concern, if she has missed more than 2 pills, or before discontinuing OCP for any reason)

45. OCP-Counseling • Follow-up 1-2 months after initiation, • every 3-4 months thereafter • Discuss strategies to obtain refills if • follow-up is less frequent (patient • should have an extra dispenser at • any time)

46. OCPApproaches Undergoing Investigation • "Quick Start" -For patients who have not had sex within the past 10 days -Negative pregnancy test -Patient initiates OCP in the clinic without waiting for her menstrual period • Extended use of OCP to a 91-day cycle (Seasonale)

47. Extended Cycle OCPMedical indications for continued use >21 days of active hormones • S/P Dysfunctional uterine bleeding (DUB)-until HGB >10.0 g/dl • When platelet count is very low • Treatment of endometriosis • Women on OCP who continue to experience menstrual symptoms or exacerbation of a medical condition (asthma, arthritis, seizures) during the active pill-free interval

48. Extended cycle regimen (allowing menses every 3 or more months)Studies in adult women • Easier to follow • Well tolerated • Efficacious in reducing menstrual-related symptoms

49. OCP and the Menstrual Cycle Tricycle regimen (Seasonale) Spring Summer Winter Autumn

50. Tricycle regimen (Seasonale) • A pill (30 mcg ethinyl estradiol/150 mcg levonorgestrel) taken daily for 84 days followed by 7 days of placebo • Estrogen/progestin similar to that found in the OCP Nordette-28