 | The 131st Annual Meeting (November 15-19, 2003) of APHA |
|
| The 131st Annual Meeting (November 15-19, 2003) of APHA |
Cynthia C. Harper, PhD, Center for Reproductive Health Research and Policy, University of California San Francisco, Box 0744, 3333 California Street, Ste. 335, San Francisco, CA 94143-0744, (415)502-4092, harperc@obgyn.ucsf.edu, Nancy sambol, PharmD, Dept. of Biopharmaceutical Sciences, University of California, San Francisco, Box 0446, San Francisco, CA 94143-0446, Corinne Rocca, MPH, Center for Reproductive Health Research and Policy, University of California, San Francisco, 3333 California Street, Suite 335, Box 0744, San Francisco, CA 94143-0744, Lena Kim, MD, Dept. of OB/GYN, University of California, San Francisco, San Francisco General Hospital, Ward 6D, 1001 Potrero Ave., San Francisco, CA 94143, Phillip Darney, MD, MSc, Center for Reproductive Health Research and Policy, University of California at San Francisco, 3333 California Street, Suite 335, San Francisco, CA 93118, and Tina Raine, MD, MPH, Department of OB/GYN, University of California, San Francisco, 1001 Potrero Avenue, Ward 6D, San Francisco General Hospital, San Francisco, CA 94110.
According to the American Academy of Pediatrics, only a small fraction of all drugs marketed in the United States has been studied in pediatric patients, and a majority of marketed drugs, including contraceptives, are not labeled or are insufficiently labeled for use in pediatric age groups. Contraceptive clinical trials only include women aged 18 and over and labeling for most contraceptives states: “Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older.” Many users of contraceptive products, including emergency contraception, are adolescents. Adolescents typically experience high contraceptive failure rates, which may be due to biological as well as behavioral factors. While behavioral studies among adolescents exist, the pharmacokinetics and effects of the drugs have not been explored. This study investigated the safety and pharmacokinetics of Plan B levonorgestrel emergency contraception among post-menarchal females. Results from the safety arm (n=60) showed that the medication is safe and well-tolerated. Subjects were able to use the medication correctly and experienced similar patterns in side effects and return to menses as in data from adult populations. Pharmacokinetics results (n=22) also showed that the medication was safe and well-tolerated, but that adolescents had lower plasma concentrations of levonorgestrel than adults, which may be due to faster clearance or lower bioavailability. These results show that biological factors, as well as behavioral, in adolescent contraception need to be investigated in future research.
Learning Objectives:
Keywords: Adolescent Health, Contraceptives
Presenting author's disclosure statement:
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: We received a small grant to complete simulations for the study design for the PK study from Women's Capital Corportion, which markets Plan B emergency contraception, the product used in the study.