| Methods |
Randomized controlled trial. The method of randomization and the use of blinding are not described. Communication with the authors indicated a computer‐generated allocation sequence and no blinding. |
| Participants |
721 women in reproductive age at 11 sites in India. Inclusion criteria were healthy women in the reproductive age exposed to the risk of pregnancy. Exclusion criteria were contraindications for oral contraceptive use. The paper does not report if switchers were included. |
| Interventions |
Triphasic levonorgestrel/ethinylestradiol (50‐75‐125 μg LNG and 30‐40‐30 μg EE in a 6/5/10 regimen and 7 days of placebo tablets, N=383) [Triquilar ED] versus
monophasic levonorgestrel/ethinylestradiol (150 μg levonorgestrel and 30 μg ethinylestradiol for 21 days and 7 days of placebo tablets, N=338) [MALA‐D]. Report does not describe the composition of the monophasic pill. Communication with the author indicated data described above. |
| Outcomes |
Principal outcome measures are: pregnancy; side effects; cycle control; continuation; discontinuation and reasons for discontinuation; metabolic outcomes. Use of recall method to collect data on pill intake errors, cycle control and side effects. Bleeding pattern was analyzed according to the recommendations by Rodriguez 1976. |
| Notes |
The report does not provide an a priori hypothesis or a sample size or power calculation. Study duration: 12 cycles. 256 women in the triphasic group and 203 women in the monophasic group discontinued early. The report describes number and reasons for discontinuation. 16 women in the triphasic group and 14 women in the monophasic group were lost to follow up. 9 women in the triphasic group and 14 women in the monophasic group were withdrawn because of protocol violations. Analysis not according to intention‐to‐treat. The trial was conducted by the Indian Council of Medical Research. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Not described in report. Communication with the authors indicated allocation concealment by sequentially‐numbered sealed envelopes |
