Pilot Study

Abstract

females. Obstet Gynecol 2012;119:772-9.) of a single-dose emergency contraceptive demonstrated young women's ability to appropriately select and correctly use the emergency contraceptive. This post hoc analysis examined the safety of the emergency contraceptive in various age subgroups. METHODS:This was a noncomparative case-series study of a single-dose 1.5 mg levonorgestrel emergency contraceptive. Eligible women were 11-17 years of age and presented to study sites requesting emergency contraception. Safety information (side effects and any medical problems) was collected by telephone or return clinic visit at approximately 1, 4, and 8 weeks after the date the emergency contraceptive was dispensed. Safety data were retrospectively assessed in the following age subgroups: 13-14, 15-16, and 17 years.RESULTS: There were 299 women included in the safety analysis (11-12 year olds, n50; 13 year olds, n52; 14 year olds, n530; 15 year olds, n587; 16 year olds, n5123; 17 year olds, n557). The incidence of treatment-emergent adverse events were 13% (4/32) in 13-14 year olds, 16% (34/210) in 15-16 year olds, and 12% (7/57) in 17 year olds. The emergency contraceptive was well tolerated in all age subgroups. The most commonly reported treatmentemergent adverse event (s) in each age subgroup was as follows: in 13-14 year olds, vaginal bleeding (6% [2/32]); in 15-16 year olds, nausea and headache (each 3% [6/210]); in 17 year olds, nausea and vulvovaginal mycotic infection (each 4% [2/57]).