Multi-site study of potential EC in gear
Women may have another choice in emergency contraception (EC) if a current multi-site trial of a potential candidate proves successful. HRA Pharma of Paris, France, has initiated a pivotal multicenter Phase III study to evaluate its proprietary second-generation emergency contraceptive.
The open-label investigation will analyze safety and efficacy of the drug, trademarked Ella (CDB-2914), as an emergency contraceptive. Study participants will include women older than age 18 who request EC within 120 hours (five days) of unprotected sexual intercourse or a contraceptive failure. More than 1,000 women are expected to participate in the trial. The company says it expects to complete the study by the end of 2007 and submit findings to the Food and Drug Administration. If the drug is approved, it may be available in United States by 2009.
Seven Planned Parenthood of America (PPFA) affiliates, representing 16 health center sites, are participating in the study, says Andrea Hagelgans, PPFA spokesperson. The affiliates and their sites include: Planned Parenthood League of Massachusetts (Boston Planned Parenthood); Planned Parenthood Mar Monte (San Jose Planned Parenthood Mar Monte and Fulton Street); Planned Parenthood of Houston and S.E. Texas (Fannin Health Center and Bryan/College Station); Planned Parenthood of Maryland (Baltimore, Towsen, and Annapolis health clinics); Planned Parenthood of the Columbia/Willamette (S.E. Portland Clinic); Planned Parenthood of the Rocky Mountains (Boulder, Denver-Central, Littleton, Aurora, and Arvada); and Planned Parenthood of Western Washington (Seattle Clinic and University District Clinic).
CDB-2914 is the first compound to have been developed expressly with EC in mind, reports Vanessa Cullins, MD, MPH, PPFA vice president for medical affairs. "Planned Parenthood believes strongly that every woman deserves every chance to prevent unintended pregnancy, and we welcome innovations that expand family planning options including backup birth control," she says.
Look at formulation
Scientists conducted a randomized, double-blinded noninferiority trial of CDB-2914 by enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse.1 Participants were randomly assigned to receive a single 50 mg dose of CDB-2914, plus a placebo 12 hours later, or two doses of 0.75 mg levonorgestrel taken 12 hours apart. Findings indicate that CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile.1
The levonorgestrel-only EC Plan B (Barr Pharmaceuticals; Woodcliff Lake, NJ) is now available "behind the counter" — but without a prescription — to consumers 18 years of age and older, and it remains prescription-only for women 17 and younger. What role will clinicians now play in EC provision?
Advance provision is still an important factor in successful use of EC, says Corinne Rocca, MPH, an epidemiologist with the Women's Global Health Imperative at the University of California, San Francisco. In a just-published randomized trial evaluating access to EC through advance provision, pharmacies, or clinics, data suggest that advance provision improved promptness and convenience of use.2
Findings from several randomized trials3-5 indicate that women who are given advance provisions to EC are more likely to use it when they need it, says Rocca, who served as lead author of the new study. Having a dose on hand eliminates the need to go to a clinic to get EC or a prescription for EC, she says. For women who have access through pharmacies, it eliminates the need to find and go to a pharmacy to get EC, Rocca points out. "As was illustrated in our clinic-based study, 14% of women did not take EC on an occasion in which they felt it was called for," says Rocca. "Reasons for this included that it was too inconvenient to get EC, the woman did not have EC or a prescription, and the woman could not obtain EC in three days."
Even with dual-status availability of Plan B, clinicians will continue to play a vital part in EC provision, Rocca believes. Clinicians continue to help women understand the need for EC, as well as provide general EC education and provision, even though the drug now is available behind-the-counter (BTC). Most women at risk for unintended pregnancy do not know about EC or know how to obtain it and use it, so clinicians can tell patients about EC and explain where they can obtain it, including which pharmacies are known to carry Plan B, she says.
"Just as we continue to rely on clinicians and health care practitioners to counsel patients about condom use — even though condoms are readily available over the counter — we will continue to rely on them to educate patients about EC, even though it can now be obtained behind the counter," says Rocca.
References
- Creinin MD, Schlaff W, Archer DF, et al. Progesterone receptor modulator for emergency contraception: A randomized controlled trial. Obstet Gynecol 2006; 108:1,089-1,097.
- Rocca CH, Schwarz EB, Stewart FH, et al. Beyond access: acceptability, use and nonuse of emergency contraception among young women. Am J Obstet Gynecol 2007; 196:29.e1-6; discussion 90.e1-5.
- Gold, MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004; 17:87-96.
- Glasier A, Fairhurst K, Wyke S, et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004; 69:361-366.
- Lovvorn A, Nerquaye-Tetteh J, Glover EK, et al. Provision of emergency contraceptive pills to spermicide users in Ghana. Contraception 2000; 61:287-293.
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