Challenges of conducting a placebo-controlled trial for dysmenorrhea in adolescents.
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.
Davis
Anne R
AR
Department of Obstetrics and Gynecology, Columbia University, New York, New York 10032, USA. ard4@columbia.edu
Osborne
Lauren M
LM
O'Connell
Katharine J
KJ
Westhoff
Carolyn L
CL
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
D003276:Contraceptives, Oral