Bleeding patterns and patient acceptability of standard or continuous dosing regimens of a low-dose oral contraceptive: A randomized trial

Marni Kwiecien, Alison Edelman, Mark D. Nichols, Jeffrey T. Jensen

Research output: Contribution to journalArticlepeer-review

124 Scopus citations

Abstract

The purpose of this study is to compare bleeding patterns and acceptability of a contraceptive regimen of combined 20 μg ethinyl estradiol/100 μg levonorgestrel taken with and without a hormone-free interval. Thirty-two women desiring oral contraception were randomized to six 28-day cycles (standard group) or 168 days without a pill-free interval (continuous group). Participants kept a daily bleeding calendar documenting bleeding events (none, spotting or required sanitary protection) and side effects (headache, nausea, breast tenderness, depression, premenstrual syndrome and bloating). Primary outcome was number of bleeding days. Secondary outcomes included bleeding days requiring sanitary protection, amenorrhea, patient acceptability of bleeding patterns, method satisfaction and affective side effects. There were no differences in the baseline characteristics of the two groups. Although total bleeding days were fewer in the continuous group (mean = 25.9 vs. 34.9 days), this result did not reach statistical significance. However, women in the continuous group reported significantly fewer bleeding days that required protection (18.4 vs. 33.8 days, p < 0.01), and were more likely to have amenorrhea. Although both groups reported a high level of satisfaction with bleeding patterns and side effect profiles, women in the continuous group reported significantly fewer days of bloating (0.7 vs. 11.1 days, p = 0.04), and menstrual pain (1.9 vs. 13.3 days, p < 0.01). Continuous use of 20 μg ethinyl estradiol/100 μg levonorgestrel is associated with less bleeding requiring protection, and more amenorrhea than standard administration. Taken with or without a hormone-free interval, this oral contraceptive formulation is highly acceptable with regard to bleeding patterns and side effect profile. The continuous group had fewer light and moderate bleeding days, less bloating and menstrual pain. For patients who are seeking these results, this method may be more desirable.

Original languageEnglish (US)
Pages (from-to)9-13
Number of pages5
JournalContraception
Volume67
Issue number1
DOIs
StatePublished - Jan 1 2003

Keywords

  • Acceptability
  • Bleeding
  • Continuous cycle
  • Levonorgestrel
  • Oral contraceptives
  • Randomized

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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