Update In Contraception 2014: New Options, New Controversies Women’s Health Initiative August 19, 2014 Cleve Ziegler, M.D

Disclosure  CME Speaker:  Bayer, Schering-Plough (Merck), Bayer, Wyeth (Pfizer)  Advisory Board:  Bayer, GSK, Schering-Plough (Merck)

Learning Objectives  1. To re-familiarize the contraceptive benefits of hormonal contraception  2. To better understand the contemporary controversies regarding risks of hormonal contraception  3. Understanding overall safety of hormonal contraception  4. Awareness of the benefits of LARC’s

Case Presentation  26 year old G0  Breakthrough bleeding on multiple oral contraceptives  Admits to missing a pill “here and there”  Smokes 10/day  Previous doc made her double on pills the days she bled  Looking for a new option

 Physiology of Menstruation  Anthropology of Menstruation  Cultural Attitudes Toward Menstruation  Update In New Contraceptive Methods  Concept of Extended Cycle Contraception and Menstrual Suppression

Normal Physiological Process Pathological Entity  Ridding the body of toxins  Sign of fertility and femininity  Physiological anemia and reduction in cardiovascular disease  Dysmenorrhea  Menorrhagia  Endometriosis  Ovarian cancer  Breast cancer  Premenstrual syndrome  Migraine headache  Epilepsy

Address Risks Caused by Unplanned Changes in Methods Finer LG. Perspect Sex Reprod Health. 2006; Moreau C. Contraception Frost JJ. In Brief Unintended Pregnancies Each Year Unintended Pregnancies Using Contraception

“Love, Sex, Freedom and the Paradox of the Pill” Time Magazine, May 3, Nancy Gibbs, Time Executive Editor “Arriving at a moment of social and political upheaval, the Pill became a handy proxy for wider trends: the rejection of tradition, the challenge to institutions, the redefinition of women’s roles”

Unintended Pregnancy in First Year of Contraceptive Use* Trussell J. Contraception 2004; 70: Women with Unintended Pregnancy within First Year of Use (%) COC=combined oral contraceptive; POP= progestin only pill; DMPA=depot medroxyprogesterone; LNG-IUS=levonorgestrel releasing intrauterine system *not head-to-head comparison of contraceptive methods

Values in % *Based on Respondents Familiar with Method Fisher WA et al. JOGC 2004;June :

Most Commonly Used Contraceptive Methods by Canadian Women DMPA=depot medroxyprogesterone Back et al. J Obstet Gynaecol Can 2009;31(7):627–640. Column totals may exceed 100% as women were allowed to choose more than one method. Base: Women aged who have had vaginal intercourse in the previous 6 months, n=2,341 % of women

Cultural PreferencesGeographic Trends

21/7 Phasic

Estrogen (µg) Mestranol Ethinyl Estradiol Year of Introduction Thorneycroft IH. Infert Clin North Am. 2000;11:

Understanding Risk: Cardiovascular Adverse Events Most serious cardiovascular adverse events associated with all COCs Farley et al., Contraception 1996; 57(3) Venous thrombo- embolism Stroke Myocardial infarction

Putting the VTE Risk into Context Ten Thousand Women Years: Dinger Contraception 2007  Non Pregnant Non Users  OC Users  Pregnant Women   

Increased Impact of Age and BMI on VTE Incidence in COC Users* BMI: body mass index *Risk estimates based on 115 VTEs in 116,708 WY of exposure Dinger, EURAS Study, Presentation EC Prague 2008.

1 Risk Factor 2 Risk Factors 3 Risk Factors Impact of Multiple Risk Factors on VTE Risk During OC Use ** Family or personal history of VTE Based on EURAS study results: not yet published

The Spin Doctors at Work…  1. Preferential prescribing of new preparations to new users  2. Most VTE in first 6 months, newer users at higher risk  3.Preferential prescribing of new drugs to higher risk patients because of perceived “safety”.  4. Preferential prescribing of drospirenone to hyperandrogenic women who have underlying vascular disease

 1 ring per cycle  Regimen: ◦ 3 weeks of ring-use ◦ 1 ring-free week  Daily release: ◦ 15 µg ethinylestradiol ◦ 120 µg etonogestrel

Css OC Pharmacokinetic profile NuvaRing and 30 EE/150 DSG COC Timmer & Mulders, Clin Pharmacokinet, 2000;39:233–42

D’Arcangues et a., Contraception. 2007; 75: S2-S7 Prevalence of IUD use in women aged 15-49, married or in union (2005)

 Intrauterine system (IUS)  Releases up to 20 μg/day of levonorgestrel (progestin)  No estrogen  5 years of treatment Indications  Contraception

Mirena provides contraception through a combination of 3 main actions: Minor effect on ovarian function 2- Inhibition of sperm function 1- Thickening of cervical mucus 3- Prevention of endometrial growth

Normal menstrual cycle Days of cycle Menstrual cycle in a woman with Mirena Endometrium in resting state Resulting in scanty bleeding

 1. Use 2 nd generation pill with lowest estrogen dose as first choice  2.If adverse effects occur, switch to 3 rd or 4 th generation pill.  3.Patients at high risk for VTE should use progestin only pill, DMPA, or IUS.  4.Use 2 nd generation pill in older women