| Methods |
Randomized controlled trial. Randomization by random number tables. The use of blinding is not described. We were unable to reach the author. |
| Participants |
170 women at 3 sites in Indonesia. Inclusion criteria were healthy women. Exclusion criteria were contraindications to oral contraceptives, use of hormonal contraceptives within the previous 3 cycles before enrollment and current pregnancy. The mean age of the 2 groups of participants differs. |
| Interventions |
Triphasic gestodene/ethinylestradiol (50‐70‐100 μg GTD and 30‐40‐30 μg EE in a 6/5/10 days regimen) [SHD 415 G] versus
monophasic desogestrel/ethinylestradiol (150 μg DSG and 30 μg EE for 21 days) [Marvelon]. |
| 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: 12 cycles. 3 women in the triphasic group and 5 women in the monophasic group discontinued early. The reasons for discontinuation are described. The report does not mention loss to follow up or withdrawals because of protocol violations. Analysis not according to intention‐to‐treat principle. The trial was supported by the manufacturer of the studied triphasic gestodene/ethinylestradiol pill (Schering). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Numbered containers |
