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: Anne R Davis, Lauren M Osborne, Katharine J O'Connell, Carolyn L Westhoff
• Journal: The Journal of adolescent health : official publication of the Society for Adolescent Medicine (J Adolesc Health) Vol. 39 Issue 4 Pg. 607-9 (Oct 2006) ISSN: 1879-1972 [Electronic] United States
• PMID: 16982402 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Contraceptives, Oral

Topics

• Adolescent
• Adolescent Behavior
• Adult
• Child
• Contraceptives, Oral (therapeutic use)
• Dysmenorrhea (drug therapy)
• Female
• Humans
• Patient Compliance
• Sexual Abstinence