| Methods |
Randomized controlled trial without blinding. Randomization by a computer‐generated randomization schedule. Randomization was stratified by center and recent hormonal contraceptive exposure (new user or switcher). The use of allocation concealment is not described. |
| Participants |
355 women at 20 centers in the USA. Inclusion criteria were healthy, nonpregnant, nonlactating, sexually active women aged 18 to 45 years who had regular menstrual cycles, negative Chlamydia test and a normal Pap test without evidence for moderate or severe dysplasia or any malignancy within the preceding 12 months. Exclusion criteria were contraindications to hormonal therapy, untreated thyroid disorder, body mass index greater than 40 kg/m2, previous discontinuation of one of the treatments due to breakthrough bleeding, receiving an hormonal injectable contraceptive within 6 months of screening, having an implant within 60 days of screening or having an hormonal intrauterine device within 3 months of screening or smoking if aged 35 to 45 years. Switchers were included in the study. The two groups of participants differed in weight and smoking status. More than 50% of the participants used hormonal contraception less than 60days before admission. |
| Interventions |
Triphasic norgestimate/ethinylestradiol (180‐215‐250 µg NGM and 25 µg EE in a 7/7/7 days regimen and 7 days of placebo tablets, N=178) [Ortho Tri‐Cyclen Lo] versus monophasic drospirenone/ethinylestradiol (3 mg DRSP and 20 µg EE for 24 days and 4 days of placebo tablets, N=177) [Yaz]. |
| Outcomes |
Outcomes measure are: cycle control, patient satisfaction, side effects. Use of an interactive voice‐response system‐based diary to collect data on daily cycle control. Bleeding and unscheduled bleeding was defined as per Mishell 2007. Unscheduled bleeding episode was defined as per Belsey 1986. |
| Notes |
The report does not provide an a priori hypothesis. The paper describes an adequate sample size calculation. Study duration: 3 cycles. 24 women in triphasic group and 21 women in monophasic group discontinued early. The reasons for discontinuation are described. 11 women in triphasic group and 10 women in monophasic group did not start oral contraceptives. 7 women in triphasic group and 4 women in monophasic group were lost to follow‐up. 2 women in both treatment groups were withdrawn because of lack of compliance. One woman in monophasic group was withdrawn because of protocol violations. The paper states states that the evaluation of bleeding patterns was based on the intent‐to‐treat population defined as all randomly assigned participants who took the study drug and for whom there was post‐baseline bleeding data after day 7. The trial was sponsored by the manufacturer of the studied triphasic norgestimate/ethinylestradiol pill (Ortho‐McNeil‐Janssen). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
