Randomized comparison of bleeding patterns in women using a combined contraceptive vaginal ring or a low-dose combined oral contraceptive on a menstrually signaled regimen

Contraception. 2015 Feb;91(2):121-6. doi: 10.1016/j.contraception.2014.10.006. Epub 2014 Oct 22.

Abstract

Objectives: To compare bleeding patterns for 12 months continuous use of a contraceptive ring [contraceptive vaginal ring (CVR)] and pill [combined oral contraceptive (COC)] on a menstrually signaled regimen and the effectiveness of 4 days "treatment withdrawal" to stop bleeding.

Study design: Women, 66 to each group, were randomized to continuous use of a CVR (15 mcg ethinyl estradiol/150 mcg etonogestrel) or a low-dose pill (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for 360 days on a menstrually signaled regimen. Bleeding/spotting days, daily use of ring or pill, was recorded. Endpoint was the total number of bleeding/spotting days for each method over four 90-day reference periods (RP) plus the analysis of bleeding patterns using modified World Health Organization criteria.

Results: There was a reduction in the mean (±S.D.) number of bleeding/spotting days from RP1 (CVR 14.2±10; pill 16.6±10.9) to RP4 (CVR 8.8±9.6; pill 8.8±9.1). Fifteen percent of CVR and 4% COC users experienced amenorrhea or infrequent bleeding throughout the study. Amenorrhea increased over time (RP1 vs. RP4: CVR 10% vs. 21% and COC 2% vs. 30%). Compliance with the menstrually signaled regimen was poor. Ceasing hormones for 4 days stopped a bleeding episode within 5 days in the majority of episodes and many stopped spontaneously.

Conclusion: Bleeding patterns with continuous use of the CVR and COC are similar and improve over 1 year of use. The unpredictability, but short duration, of bleeding episodes should be stressed during counseling.

Implication: This information for clinicians and women about breakthrough bleeding patterns with use of a CVR or combined pill over 12 months using a menstrually signaled regimen will give women an indication of what to expect with continuous use.

Keywords: Compliance; Convenience; Duration; Frequent bleeding/spotting.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Amenorrhea / chemically induced
  • Contraceptive Agents, Female / administration & dosage
  • Contraceptive Agents, Female / adverse effects*
  • Contraceptives, Oral, Combined / administration & dosage
  • Contraceptives, Oral, Combined / adverse effects*
  • Desogestrel / administration & dosage
  • Desogestrel / adverse effects
  • Drug Combinations
  • Drug Monitoring
  • Ethinyl Estradiol / administration & dosage
  • Ethinyl Estradiol / adverse effects
  • Female
  • Humans
  • Intrauterine Devices, Medicated / adverse effects*
  • Levonorgestrel / administration & dosage
  • Levonorgestrel / adverse effects
  • Medication Adherence
  • Menorrhagia / chemically induced
  • Menorrhagia / etiology
  • Menorrhagia / prevention & control*
  • Menstrual Cycle / drug effects*
  • Metrorrhagia / chemically induced
  • Metrorrhagia / etiology
  • Metrorrhagia / prevention & control*
  • New South Wales
  • Patient Education as Topic
  • Patient Satisfaction
  • Self Care*
  • Young Adult

Substances

  • Contraceptive Agents, Female
  • Contraceptives, Oral, Combined
  • Drug Combinations
  • ethinyl estradiol, levonorgestrel drug combination
  • etonogestrel
  • Ethinyl Estradiol
  • Levonorgestrel
  • Desogestrel

Associated data

  • ANZCTR/ACTRN12609000391279