Pill power: Clinicians speak out on OC choices
The young woman sitting in front of you is in good health and says she would like to use a birth control pill. Which pill do you prescribe?
Almost 25% of respondents to the 2005 Contraceptive Technology Update Contraception Survey say their No. 1 oral contraceptive (OC) of choice for a 21-year-old nonsmoker is Ortho Tri-Cyclen Lo (Ortho-McNeil Pharmaceutical, Raritan, NJ). With a daily dose of 25 mcg of estrogen for 21 days and three doses of the progestin norgestimate (180 mcg daily/days 1-7; 215 mcg daily/days 8-14; 250 mcg daily/days 15-21), the pill maintains its top position for the second year, with similar figures to 2004’s percentages.
Ortho Tri-Cyclen Lo generally is well tolerated, has a low estrogen content, and few side effects, says Julia McAndrew, NP, a nurse practitioner at the Cattaraugus County Health Department Family Planning Clinic in Olean, NY.
"If problems occur, patients can be switched to a different OC," she notes. "Also, for the younger patients especially, I think the advertising for this product is helpful in pill recognition and assisting in compliance with use."
Other leading choices in the category include Yasmin, a monophasic pill containing 3 mg drospirenone and 0.030 mg ethinyl estradiol from Berlex Laboratories, Montville, NJ; Alesse, a monophasic 20-mcg pill from Wyeth Pharmaceuticals, Collegeville, PA; and Ortho Tri-Cyclen, a 35 mcg ethinyl estradiol phasic pill also marketed by Ortho-McNeil. (See the graphic about top nonformulary pills.)
When bound by formulary, about 30% of 2005 survey participants say they write prescriptions for Ortho Tri-Cyclen Lo for young nonsmoking women. Ortho Tri-Cyclen (16.75%), Alesse (13.09%), and Yasmin (7.33%) followed in the 2005 formulary category.
Extended regimen in use
Clinicians continue to look at extended regimens of oral contraceptives for their patients; about 18% of 2005 survey participants say they have prescribed Seasonale (Barr Pharmaceuticals, Woodcliff Lake, NJ), the first dedicated extended regimen pill, in the last six months. Survey participants also named Yasmin (22%), Mircette (18%, Organon, West Orange, NJ), Cyclessa (11%, Organon) and Apri (11%, Barr Pharmaceuticals) as the pills most often provided in the noted time span.
Barr Pharmaceuticals has received an approvable letter from the Food and Drug Administration (FDA) for another extended regimen contraceptive pill, Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg for 84 days and ethinyl estradiol tablets 0.01 mg for seven days.)
To obtain final approval, Barr has been requested to provide additional data to support Seasonique’s unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen.1
Wyeth has just announced that it has filed a New Drug Application with the FDA for a new combination oral contraceptive containing levonorgestrel/ ethinyl estradiol with a first-of-its-kind dosing regimen. The pill is designed to be taken every day, without a placebo phase, and eliminates the menstrual cycle.
According to the company, data from two one-year Phase III clinical trials were included in the drug’s application support documentation. The trials enrolled a total of 2,775 women and evaluated the safety and efficacy of the product for contraception; in addition, one of the secondary endpoints included was menses inhibition.2
The most commonly reported adverse events in the trials included headaches, vaginal bleeding, and cramps, states the company.2
The year 2005 marks the initial addition of Yasmin to the Contraception Survey pill list; the pill has gained wide usage following its 2001 approval by the FDA.
Yasmin has been studied for potential use in treating premenstrual syndrome, says Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles (UCLA) and medical director of the women’s health care programs at Harbor-UCLA Medical Center in Torrance. It also is eyed as a preferred pill for women with polycystic ovary syndrome, says Nelson.
Yasmin soon may be joined by another drospire-none pill; the FDA issued an approvable letter for Yaz, a 20 mcg pill also developed by Berlex Laboratories, in November 2004. The agency has asked Berlex for further documentation on the pill’s unique dosing regimen: 24 days of active pills followed by four days of placebo pills. In addition to seeking an indication as an oral contraceptive with its FDA submission, Berlex also is asking for approval of Yaz as a treatment option for women with symptoms of premenstrual dysphoric disorder (PMDD) who desire pregnancy prevention.
"The FDA is currently reviewing Yaz and we expect to hear back by the end of the year," reports Kim Schillace, company spokeswoman.
Scientists believe Yaz’s effectiveness in relieving PMDD symptoms lies in its shortened pill-free interval of its dosing regimen, combined with its progestin, drospirenone (3 mg), which exhibits anti-mineralocorticoid and anti-androgenic activity.3
In a just-published study, results from a multicenter, double-blind, randomized clinical trial suggest the drug improves symptoms associated with premenstrual dysphoric disorder.4
References
- Barr Pharmaceuticals. Barr Receives Approvable Letter for Duramed’s Seasonique(TM) Extended-Cycle Oral Contraceptive. Press release. Aug. 18, 2005. Accessed at: www.barrlabs.com/pages/nprpr.html.
- Wyeth Pharmaceuticals. Wyeth’s New Drug Application for New Oral Contraceptive with Uninterrupted Dosing Regimen Accepted for Filing at FDA. Press release. July 27, 2005. Accessed at: www.wyeth.com/news/Pressed_and_Released/pr07_27_2005_13_21_44.asp.
- Bachmann G, Sulak PJ, Sampson-Landers C, et al. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinyl estradiol and 3 mg drospirenone. Contraception 2004; 70:191-198.
- Yonkers KA, Brown C, Pearlstein TB, et al. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol 2005; 106:492-501.
Survey Profile
A total of 191 providers participated in the 2005 Contraceptive Technology Update Contraception Survey. Results were tallied and analyzed by Thomson American Health Consultants in Atlanta, publisher of CTU.
About 55% of responses came from nurse practitioners or registered nurses. Physicians represented about 37% of the responses, with allied health professionals and health educators making up about 2% of the response group. About 7% listed other professions. Some 76% of respondents identified themselves as care providers, with nearly 18% involved in administration.
More than 44% of the respondents said they were employed at public health facilities or community centers (including Planned Parenthood facilities), with about 31% working in private practice settings. About 11% listed student health centers as their place of employment, with some 7% working in hospitals.
When it comes to location, 34% said they worked in an urban setting. About 35% said they were employed in a rural facility, while 27% listed a suburban location.
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