Jensen 2012.
Study characteristics | ||
Methods | Randomized clinical trial. Open label. Multicentered trial (84 U.S. sites). Funded by Bayer. | |
Participants | Age: 18‐45 years old No COC contraindications Regular menstrual cycles No history of infertility Normal pap BMI up to 35 kg/m2 |
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Interventions | Flexible regimen (continuous for at least 24 days, with 4‐day hormone free interval initiated anytime from cycle day 25‐120; N = 234) versus 28‐day cycles (24 days with a 4‐day hormone free interval; N = 232). 3 mg drospirenone and 20 mcg ethinyl estradiol | |
Outcomes | Bleeding profile, contraceptive efficacy, satisfaction, safety | |
Notes | Computer‐generated randomization (blocks of 6). Bleeding defined using WHO criteria. Power analysis included. Power analysis included. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |