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Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial

2003; Lippincott Williams & Wilkins; Volume: 101; Issue: 4 Linguagem: Inglês

10.1016/s0029-7844(03)00014-0

1873-233X

Leslie Miller, James P. Hughes,

Endometriosis Research and Treatment

To compare bleeding profiles of a traditional 28-day oral contraceptive pill cycle with continuous administration. After a 28-day run-in cycle, women were randomized to either 28-day cycles (21 active pills and a pill-free week) or continuous use of the same 20-μg ethinyl estradiol/100-μg levonorgestrel formulation for 12 study cycles (336 days). The number of bleeding and spotting days were measured by daily diary. A subset underwent cycle 1 (n = 16), and nine (n = 14) pelvic ultrasound and endometrial histology sampling. Blood pressure, weight, hemoglobin, and adverse events were measured at revisit. The sample size with 80% power to detect a 67% reduction in bleeding days required 27 subjects in each arm. Of the 79 subjects randomized, 28 (70%) of the 28-day cycle and 32 (82%) of the continuous-use subjects completed the entire study (P = .6). With continuous use, 49%, 68%, and 88% of women reported no bleeding during cycles 2, 6, and 12, respectively. Amenorrhea or infrequent bleeding was present in 68% of continuous users during cycles 1–3 and increased to 88% during cycles 10–12. Spotting during cycle days 1–21 increased initially with continuous use but reduced over time, and by 9 months was less than the spotting reported by cyclic users. Adverse events, blood pressure, weight, and hemoglobin findings were similar between groups. Extension of the 28-day oral contraceptive cycle to continuous use with a low-estrogen dose combination oral birth control pill resulted in significantly fewer bleeding days.