ABSTRACT
OBJECTIVE: To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon). DESIGN: Integrated analysis of 11 international clinical trials. SETTING: Contraceptive clinics in U.S., Chile, Asia, and Europe. PATIENT(S): A total of 942 healthy women, aged 18 to 40 years. INTERVENTION(S): Insertion of an ENG implant. Most women were enrolled in studies lasting either 2 or 3 years. MAIN OUTCOMES MEASURE(S): Efficacy was measured by the cumulative Pearl Index in women Subject(s)
Contraceptive Agents, Female/administration & dosage
, Desogestrel/administration & dosage
, Adolescent
, Adult
, Clinical Trials as Topic
, Desogestrel/adverse effects
, Female
, Humans
, Pregnancy
, Time Factors
, Uterine Hemorrhage/etiology
