4-periods-per-year OC: Comparable to pill
Initial research presented at the recent national meeting of the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG) indicates that a four-periods-per-year pill appears to prevent pregnancy and has a comparable safety profile to more traditional oral contraceptives (OCs.)1,2
The pill, Seasonale, is being developed by Pomona, NY-based pharmaceutical manufacturer Barr Laboratories in agreement with the Medical College of Hampton Roads, Eastern Virginia Medical School in Norfolk.
At press time, Barr Laboratories said it expects to file a New Drug Application for the drug with the Food and Drug Administration in mid-2002, based upon its preliminary review of the results of the trial. The company is continuing to examine the drug’s performance in an ongoing extension study, with 300 patients enrolled in the investigation.
Look at the results
The Seasonale regimen is designed to reduce the number of withdrawal bleeds from 13 to four per year. Under its regimen, women take Seasonale for up to 84 consecutive days, followed by seven days of placebo. This pill-taking regimen contrasts with the majority of OCs, which are based on a regimen of 21 treatment days, followed by seven days of placebo.
Seasonale’s Phase III clinical program was designed to investigate the efficacy and safety of the drug’s extended OC therapy used for one year in women seeking pregnancy prevention. About 1,400 women at 47 sites in the United States participated in the randomized four-arm, open-label, multicenter trial. Women received one of the following OC therapies:
- Seasonale (continuous 84/7 0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol);
- Seasonale (continuous 84/7 0.100 mg of levonorgestrel/0.020 mg of ethinyl estradiol);
- Nordette 28-day tablets (King Pharmaceuti-cals, Bristol, TN), (0.15 mg of levonorgestrel/0.03 mg of ethinyl estradiol);
- Levlite 28-day tablets (Berlex Laboratories, Montville, NJ), (0.100 mg of levonorgestrel/0.020 mg of ethinyl estradiol).
Among treated patients, both levels of Seasonale extended OC therapy prevented pregnancy comparable to Nordette and Levlite (based on the Pearl index) in women between the ages of 18 and 35. The adverse profile of the Seasonale drug was similar to that of other OCs, study findings suggest.
Breakthrough bleeding and spotting were the most common side effects of the Seasonale regimen; however, the bleeding and spotting decreased over time, says Freedolph Anderson, MD, an OB/GYN at Eastern Virginia Medical School and author of the poster presentation at the ACOG meeting. About 7% of women using the Seasonale regimen discontinued it because of breakthrough bleeding and spotting.
Fate of fewer periods?
Women’s attitudes regarding menstruation are changing, observes Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. When Kaunitz brings up the potential benefits of hormonal therapy to decrease menstruation with his patients, he says they seem more familiar with and receptive to this approach than before; nonetheless, many women still ask, "Isn’t that unnatural?" Educating women about their reproductive anatomy and physiology will represent a key part of encouraging greater use of "Seasonale-type" extended cycle OC use, as well as use of other hormonal contraceptives to reduce menses, he notes.
In addition to extended cycle OC use, Kaunitz says he uses Depo-Provera (depot medroxyprogesterone acetate injection, Pharmacia Corp., Peapack, NJ) and Mirena (levonorgestrel intrauterine system, Berlex Laboratories) in his practice for the purpose of reducing menstrual flow, including use in women with menorrhagia associated with fibroids.
He looks to results of clinical trials of extended use of the contraceptive patch (Evra, Ortho McNeil Pharmaceuticals, Raritan, NJ) and vaginal ring (NuvaRing, Organon, West Orange, NJ) to see if these new contraceptives can be used to safely and effectively reduce menstruation.
Most women "loved" the Seasonale regimen, comments Anderson. Even many of those who had difficulty with bleeding and spotting wanted to continue, or wanted to stop the regimen and try again, even though the protocol would not allow such practice, said Anderson.
If the product does reach the marketplace, clinicians will need to offer careful counseling to prepare women to expect some breakthrough bleeding and spotting with postponement of menses, he notes.
References
1. Anderson FD. Results from a multicenter, open-label, Phase III study of Seasonale, a novel 91-day extended oral contraceptive (OC). Presented at the 50th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. Los Angeles; May 2002.
2. Anderson FD. The safety and efficacy of Seasonale, a novel 91-day extended oral contraceptive regimen. Obstet Gynecol 2002; 99(suppl):26S.
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