Original researchContinuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial☆
Section snippets
Materials and methods
The study was approved by the local Institutional Review Board, and women were recruited by flyer for contraception without an emphasis on the potential for bleeding reduction. Women were screened by telephone for exclusions before the clinic visit. The study was conducted from January 2000 to September 2001 at a University-affiliated, metropolitan, dedicated research clinic. Subjects were excluded for age less than 18 years or greater than 45 years; standard contraindications to combined OC
Results
Seventy-nine women were enrolled and randomized by August 2000. Data collection was completed by September 2001. Study completion rates by treatment arm and reasons for exclusion and dropout are listed in Figure 1. Table 1 compares the enrollment demographics and baseline characteristics of the two study populations.
There were no statistical differences in age, body mass index, gravidity, parity, partner status, ethnicity, smoking status, education, or prior OC use history between the two
Discussion
Continuous administration of a 20-μg ethinyl estradiol monophasic OC was well tolerated and significantly reduced bleeding compared with cyclic use. Spotting days declined over time with continuous or daily use, and study dropout because of unacceptable bleeding was rare. By study cycle 2 (56 days of daily OC use), 49% of the continuous-use subjects reported no bleeding. This increased to 68% by cycle 6, and by year’s end 88% of continuous-use subjects reported no bleeding (Figure 2). Complete
Acknowledgements
We acknowledge Erika Lease and Suzannah Stout, our study coordinators, for collecting the data and making the research happen.
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This investigator-initiated study was funded by Wyeth Laboratories, Philadelphia, Pennsylvania.