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February 11, 2015
Perspective Article Calls for More Hormonal Contraceptive Clinical Trials in Teens

Columbus, OH—Despite their widespread use in adolescents, the overwhelming majority of hormonal contraceptive agents have not been adequately studied in pediatric populations, according to a new perspective article.

The report, published recently in the journal Pediatrics, notes that pharmacokinetic data are lacking because few industry-sponsored trials have enrolled subjects younger than 18 years of age and that trials designed to focus on adolescents typically exclude those younger than 16.

Andrea E. Bonny, MD, of Nationwide Children’s Hospital in Columbus, OH, and colleagues note that adolescents are frequently prescribed hormonal contraceptive agents for both contraceptive and noncontraceptive purposes.

“Over half of all sexually experienced females aged 15 to 19 have used some form of hormonal contraception: 56% oral contraceptive pills (OCPs), 20% injectable, 14% emergency, 10% patch, and 5% ring,” according to the perspective article. “Given that 50% of adolescent girls have been sexually active before age 18, [about] 1 in 4 adolescent girls will be exposed to hormonal contraceptives by age 18.”

The report notes that teenagers also are more likely than adult women to use hormonal contraceptives for purposes other than birth control; 33% of adolescents on birth control pills use the method solely for noncontraceptive purposes.

Those noncontraceptive benefits are of “particular importance” during adolescence, according to the authors, who point out that hormonal contraceptives decrease menstrual flow, anemia, painful periods, acne, functional ovarian cysts, as well as other menstrual-related symptoms such as premenstrual syndrome, headaches, and epilepsy.

The article discusses menstrual irregularity in some detail, noting that the problem is common during the first 2 years after onset of menstrual periods. Because the irregular periods can lead to prolonged excessive bleeding, they are especially a problem for girls with bleeding disorders, sickle cell disease, polycystic ovary syndrome, or developmental delays.

With the median age at menarche at 12 to 13 years of age, girls aged 10 to 12 years may be menstruating and have reason to be prescribed hormonal contraceptive agents, the authors suggest, adding, “Especially few data are available regarding hormonal contraceptive use in girls under the age of 13.”

“Efficacy is generally extrapolated from adult data and expected to be the same for post-pubertal adolescents as for adults,” the authors write. “This assumption ignores not only distinctive physiologic factors of pediatric populations, but also unique characteristics that impact ‘real-life’ efficacy such as lower health literacy and reduced adherence. Adolescents are more likely than adult women to discontinue, restart, or change hormonal contraceptive methods.”

Despite significant advancements in pediatric pharmaceutical testing with passage of the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA), “hormonal contraceptive testing has seen limited to no advancement in this patient population. Hormonal contraceptive agents have not been included in priority needs lists or studies requested under the BPCA,” according to the perspective article.

Stating that “reluctance to conduct pediatric contraceptive testing can no longer be justified,” the authors argue, “The time has come for pediatric and contraceptive trials networks to begin to perform pharmacokinetic/pharmacodynamic studies in this important population.”

They call for providers serving adolescent girls, as well as their professional societies, to lobby for trials in the population.

“Hormonal contraceptives represent one of the few drug classes taken long-term by otherwise healthy adolescents,” the authors add. “The neglect of pediatric patients in hormonal contraceptive testing represents an indefensible health disparity that must be remedied. This health disparity will likely worsen should the current situation continue.”


U.S. Pharmacist Social Connect