title: Challenges of conducting a placebo-controlled trial for dysmenorrhea in adolescents.
abstract: We recruited adolescents to study oral contraceptives versus placebo for dysmenorrhea. We anticipated high discontinuation and concerns about safety, side effects, and sexual behavior. Treatment discontinuation (11%) and loss to follow-up (1%) were lower than expected. The most common reason for nonenrollment was logistical issues (63%). Most participants remained abstinent.
authors.affiliation: Department of Obstetrics and Gynecology, Columbia University, New York, New York 10032, USA. ard4@columbia.edu
authors.forename: Anne R
authors.initials: AR
authors.lastname: Davis
authors.forename: Lauren M
authors.initials: LM
authors.lastname: Osborne
authors.forename: Katharine J
authors.initials: KJ
authors.lastname: O'Connell
authors.forename: Carolyn L
authors.initials: CL
authors.lastname: Westhoff
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000328:Adult; D002648:Child; D003276:Contraceptives, Oral / Q000627:therapeutic use*; D004412:Dysmenorrhea / Q000188:drug therapy*; D005260:Female; D006801:Humans; D010349:Patient Compliance; D012746:Sexual Abstinence
chemical_list: D003276:Contraceptives, Oral