Cycle control, tolerability, and satisfaction among women switching from 30-35 microg ethinyl estradiol-containing oral contraceptives to the triphasic norgestimate/25 microg ethinyl estradiol-containing oral contraceptive Ortho Tri-Cyclen LO.
Author(s): Poindexter AN, Burkman R, Fisher AC, LaGuardia KD
Affiliation(s): Baylor College of Medicine Houston, Texas, USA.
Publication date & source: 2003-07, Int J Fertil Womens Med., 48(4):163-72.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
OBJECTIVE: To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg). DESIGN: A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 microg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6,054 for Ortho Tri-Cyclen LO and 3,814 for Loestrin Fe 1/20. Additional analyses evaluated switchovers from Ortho Tri-Cyclen to Ortho Tri-Cyclen LO (N = 111). MAIN OUTCOME MEASURES: Cycle control was assessed by daily diary cards reporting the frequency, severity, and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire. RESULTS: The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1/20. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6%, respectively) and Loestrin Fe 1/20 (3.2% and 0.7%, respectively). More women on Ortho Tri-Cyclen LO versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6, 89.3% of Ortho Tri-Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied, and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conclusions-Switchovers from OCs containing 30-35 microg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability, and were satisfied.