A Good Option For Many: Focus on Extended Regimen OCs

1. A Good Option For Many:Focus on Extended Regimen OCs Lee Shulman, MD Professor and Chief Division of Reproductive Genetics Department of Obstetrics and Gynecology Feinberg School of Medicine Northwestern University Chicago, Illinois Chair, Association of Reproductive Health Professionals Washington, DC Anne Moore, MSN, ANP, FAANP Professor of Nursing/WHNP Vanderbilt University Chair of the Board National Association of Nurse Practitioners and Women’s Health Nashville, Tennessee This online offering from Sexuality, Reproduction and Menopause is supported by a grant from Duramed Pharmaceuticals, Inc.

2. No Physiological Need for Withdrawal Bleed • Use of the term “withdrawal bleed” rather than period is not just semantics: it highlights the issue of how OCs work, namely, by suppressing ovarian function. • Clinicians may find that women understand the withdrawal bleed is not medically necessary but they believe it is culturally important. • Women who rely on the withdrawal bleed for reassurance that they have not become pregnant after missing pills should be counseled specifically about signs of pregnancy and the importance of regular pill taking.

3. Contraceptive Efficacy • The risk of pregnancy increases with each day of delay in starting a new pill pack. • Better pill-taking rituals are likely to reduce the typical failure rate seen with OCs (8%).1 1 Trussel J. Contraception. 2004;70:89-96.

4. Adverse Effects • Adding estrogen to the traditional hormone-free interval has the potential to produce a more acceptable side effect profile. • Unscheduled bleeding is the side effect most associated with extended regimen OCs. • Unscheduled bleeding is particularly common in long first cycle1 • Rates of unscheduled bleeding begin to equalize after first cycle2,3 • Patients should be counseled to expect unscheduled bleeding • A pelvic exam, and possibly an ultrasonographic exam, should be done to rule out other causes of bleeding 1Anderson FD, et al. Contraception. 2003;68:89-96. 2Anderson FD, et al. Contraception. 2006;73:229-234. 3Anderson FD, et al. Am J Obstet Gynecol. 2006;195:92-96.

5. Safety: Extended Regimens • There is no apparent additional risk of thromboembolic events compared with traditional regimens.1 • There is no evidence of an increased risk of breast cancer in either current or past OC users,2 even in carriers of BRCA mutations.3 1 Anderson FD, et al. Contraception. 2006;73:229-234. 2 Marchbanks et al. N Engl J Med. 2002;346:2025-2032. 3 Milne RL, et al. Cancer Epidemiol Biomarkers Prev. 2005;14:350-356.

6. Major Lifestyle Benefit: Improved PMS/PMDD Symptomatology • Fewer periods of hormone-withdrawal reduces the frequency of symptoms. • Women experience an improvement in physical symptoms1,2: • Breast tenderness • Headache • Bloating • Cramping • And improvements in emotional symptoms.3 PMS, premenstrual syndrome; PMDD, premenstrual dysphoric disorder. 1Sulak P, et al. Headache. 2007;47:27-37. 2Coffee AL, et al. Contraception. 2007;75:444-449.3Coffee AL, et al. Am J Obstet Gynecol. 2006;195:1311-1319.

7. Conclusions: Key Patient Counseling Messages • When the regimen is started, unscheduled bleeding is likely. It is a nuisance, but should be considered a tradeoff for the considerable benefits of these regimens. • The best regimen is one that a woman is going to use consistently and correctly. • Women have many options, and information from her clinician should help her to consider the full range.

8. Contraceptive Counseling Issues Practice Recommendations • Assess contraceptive needs • Length of use desired • Need to prevent pregnancy • Hormonal contraindications • Cost • Determine appropriate delivery system • Oral • Transdermal • Vaginal • Intrauterine • Barrier • If oral, transdermal, or endovaginal, discuss • Desire for monthly withdrawal bleeds • Frequency of such withdrawal bleeds