| Methods |
Randomized controlled trial without blinding. The method of randomization and the use of allocation concealment are not described. Report notes stratification using postpartum status as the stratification variable. We were unable to reach the authors. |
| Participants |
373 women at 10 sites. Inclusion criteria were healthy women aged 18 to 50 years. Exclusion criteria were disorders considered to be contraindications for steroid hormonal therapy and use of oral contraceptives within 60 days of enrollment. Analysis of 2 groups: safety population (all participants who received at least one dose of study medication); intent‐to‐treat population (all participants who received at least one dose of study medication and who had at least one cycle control measurement). The safety population consisted of 335 women and the intent‐to‐treat population of 328 women. Participants used a nonsteroidal contraceptive method for the first 7 days of cycle 1. |
| Interventions |
Triphasic norgestimate/ethinylestradiol (180‐215‐250 μg NGM and 35 μg EE in a 7/7/7 days regimen and 7 days of placebo tablets, N=187) [Ortho Tri‐Cyclen] versus
monophasic norethindrone acetate/ethinylestradiol (1000 μg NETA and 20 μg ethinylestradiol for 21 days and 7 days of placebo tablets, N=186) [Loestrin 1/20]. |
| Outcomes |
Primary outcomes measures are: efficacy; side effects; cycle control; continuation and reasons for discontinuation; pill intake errors. The method to collect data is not described. The report does not describe the definitions of breakthrough bleeding and spotting. |
| Notes |
The report does not provide an a priori hypothesis or a sample size or power calculation. Study duration: 6 cycles. 72 women in the triphasic group and 70 women in the monophasic group discontinued early. Limited information on reasons for discontinuation. 16 women in the triphasic group and 22 women in the monophasic group did not start oral contraceptives. The report does not describe the number of women lost to follow up or excluded because of protocol violations. The paper indicated an analysis based on the intent‐to‐treat principle but participants not starting oral contraceptives and invalid cycles were excluded from analysis. Errors in pill intake, a cycle length longer than 31 days, errors in non‐active pill intake and errors in recording cycle information all create invalid cycles. The trial was sponsored by the manufacturer of the triphasic norgestimate/ethinylestradiol pill (Ortho‐McNeil Pharmaceutical). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
