The options expand for extended regimen OCs
With the recent Food and Drug Administration approval of Quartette, a new extended regimen oral contraceptive (OC) from Teva Pharmaceuticals of North Wales, PA, providers have more options to present to women considering this form of birth control.
The new extended oral contraceptive incorporates an ascending-dose approach, with 20, 25 and 30 mcg of ethinyl estradiol, combined with 150 mcg of levonorgestrel over 84 days, followed by seven days of 10 mcg of ethinyl estradiol alone, says Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine — Jacksonville. Kaunitz served as a principal investigator in Quartette’s clinical trial.
“Compared with earlier trials of fixed-dose extended pills, use of this ascending dose formulation appears to associated with less unscheduled bleeding and spotting, making it an attractive option for women seeking to reduce both the frequency of scheduled bleeding as well as the incidence of unscheduled bleeding and spotting,” Kaunitz states.
Results from the Phase III clinical trial indicate that Quartette is effective at preventing pregnancy. The most common adverse reactions reported in the trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increase, mood changes, anxiety/panic attack, breast pain, and migraines.1 Breakthrough bleeding and unscheduled spotting decreased over successive 91-day cycles, according to results from the drug’s primary clinical trial.1
Why extend regimen?
Women and providers are familiar with traditional OC regimens that include 21 days of hormones, followed by a seven-day hormone-free interval. This interval, however, can result in hormone withdrawal symptoms in women who are sensitive to fluctuating hormone levels.2
With extended-cycle regimens, the hormone-free interval is shortened or eliminated to manage common menstrual symptoms such as headaches, tiredness, bloating, excessive bleeding, and menstrual pain.
A 2005 systematic review of extended-cycle versus traditional 28-day cycle OCs found similar efficacy and safety between the two types of regimens.3 It remains unknown whether the additional weeks of hormone exposure increase the risk of venous thromboembolism in extended-cycle users.4
Results of a 2011 survey of providers at six national medical conferences show that of the 799 providers surveyed, 92% had recommended extended-cycle regimens, with obstetrics and gynecology practitioners most likely to recommend their use.5 However, 73.5% of providers indicated they continue to prescribe OCs that induce monthly withdrawal bleeds as their most common regimen.5
For extended regimen pills, there are four 30 mcg ethinyl estradiol/150 mcg levonorgestrel pills, packaged as 84 active pills and seven placebo pills: Seasonale and Jolessa (Teva Pharmaceuticals, North Wales, PA), Quasense (Watson Pharmaceuticals, Morristown, NJ), and Introvale (Sandoz, Princeton, NJ). There are three 30 mcg ethinyl estradiol/150 mcg levonorgestrel and 10 mcg ethinyl estradiol pills, packaged as 84 active pills and seven low-dose estrogen pills: Seasonique and Camrese (Teva Pharmaceuticals) and Amethia (Watson Pharmaceuticals). There are three 20 mcg ethinyl estradiol/100 mcg levonorgestrel pills and 10 mcg pills, packaged as 84 active pills and seven low-dose estrogen pills: LoSeasonique and CamreseLo (Teva Pharmaceuticals) and Amethia Lo (Watson Pharmaceuticals).
There are two continuous regimen pills, containing 20 mcg ethinyl estradiol/90 mcg levonorgestrel, packed as 28-day packs with no hormone-free interval: Lybrel (Wyeth Pharmaceuticals, Philadelphia) and Amethyst (Watson Pharmaceuticals).6
Which women might be best candidates for extended regimen OCs? Women who are not interested in using an intrauterine device, contraceptive implant, contraceptive injection, or contraceptive vaginal ring in lieu of a daily pill, says Eleanor Bimla Schwarz, MD, MS, director of the Women’s Health Services Research Unit and associate professor of medicine, epidemiology, and obstetrics, gynecology, and reproductive sciences at the University of Pittsburgh (PA).
Tips for counseling patients
What are some important counseling tips to help women achieve success with this form of birth control?
Schwarz suggests that if spotting becomes problematic, women may take a three-day break and then restart pills for at least three weeks before the next break.
Because routine use of extended-cycle and continuous OCs is relatively new and differs from what women have been told about the importance of monthly bleeding, clinicians need to be ready to answer questions about the absence of a monthly bleed.7
Explain that there is no medical or health reason to bleed while on hormonal contraceptives.8 Assure women that menstrual blood does not build up when women are using hormonal birth control. Return to fertility after discontinuation is expected to be the same as for conventional pills.8 [On April 2, 2013, Contraceptive Technology Update issued an e-bulletin on the drug’s approval. To receive breaking news as it occurs, provide your email address to AHC Media customer service at [email protected] or (800) 688-2421.]
At a time when women can buy combined pills for $4 to $10 per cycle at national “big box” retail stores, Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta, says he is “underwhelmed” by this new approach to hormonal contraception. When Quartette hits market shelves later this year, it well could be introduced as the most expensive oral contraceptive ever marketed in the United States, predicts Hatcher.
“My other concern is that the changing dosages of hormones will be confusing to both clinicians and women using this new preparation,” Hatcher states.
Reference
1. Portman DJ, Howard B, Weiss H, et al. Multicenter open-label study to evaluate efficacy and safety of an ascending-dose, extended-regimen ethinyl estradiol/levonorgestrel combination oral contraceptive for preventing pregnancy in women. Presented at the 68th Annual Meeting of the American Society of Reproductive Medicine. San Diego; October 2012.
2. Sulak PJ, Scow RD, Preece C, et al. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol 2000; 95(2):261-266.
3. Edelman AB, Gallo MF, Jensen JT, et al. Continuous or extended cycle vs. cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev 2005; 20(3):CD004695.
4. Spencer AL, McNamara MC, Bonnema R. Guide to contraceptive counseling for women with medical comorbidities. Part 1. Female Patient 2011; 36(10):22-30.
5. Seval DL, Buckley T, Kuehl TJ, et al. Attitudes and prescribing patterns of extended-cycle oral contraceptives. Contraception 2011; 84(1):71-75.
6. Jacobson JC, Likis FE, Murphy PA. Extended and continuous combined contraceptive regimens for menstrual suppression. J Midwifery Womens Health 2012; 57(6):585-592.
7. Nelson AL. Communicating with patients about extended-cycle and continuous use of oral contraceptives. J Womens Health (Larchmt) 2007; 16(4):463-470.
8. Association of Reproductive Health Professionals. Menstrual suppression. Fact sheet. Accessed at http://bit.ly/14O4zyX.
With the recent Food and Drug Administration approval of Quartette, a new extended regimen oral contraceptive (OC) from Teva Pharmaceuticals of North Wales, PA, providers have more options to present to women considering this form of birth control.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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