Efficacy, cycle control, and side effects of low- and lower-dose oral contraceptives: a randomized trial of 20 micrograms and 35 micrograms estrogen preparations

Contraception. 1999 Dec;60(6):321-9. doi: 10.1016/s0010-7824(99)00109-2.

Abstract

Estrogen content represents a tradeoff between cycle control and side effects, but few direct comparisons of 20 and 30/35 micrograms preparations are available. To address this issue, we conducted a randomized, open-label multicenter clinical trial comparing Alesse (20 micrograms ethinyl estradiol [EE]), Mircette (20 micrograms EE), and Ortho Tri-Cyclen (35 micrograms EE) among 463 OC starters or switchers. Bloating, breast tenderness, and nausea were approximately 50% more common in women using 35 micrograms EE as compared to 20 micrograms EE preparations. Cycle control was similar in all products, although during the first two cycles among starters; users of Mircette and Ortho Tri-Cyclen (Tri-Cyclen) exhibited better cycle control than Alesse users. Discontinuation and pregnancy rates were not significantly higher in 35 micrograms EE users.

PIP: Estrogen content represents a tradeoff between cycle control and side effects, but few direct comparisons of 20 and 30/35 mcg preparations are available. To address this issue, researchers conducted a randomized, open-label multicenter clinical trial comparing Alesse (20 mcg ethinyl estradiol [EE]), Mircette (20 mcg EE), and Ortho Tri-Cyclen (35 mcg EE) among 463 oral contraceptive starters or switchers. Bloating, breast tenderness, and nausea were approximately 50% more common in women using 35 mcg EE as in those using 20 mcg EE preparations. Cycle control was similar in all products, although during the first two cycles among starters, users of Mircette and Ortho Tri-Cyclen (Tri-Cyclen) exhibited better cycle control than Alesse users. Discontinuation and pregnancy rates were not significantly higher in 35 mcg EE users.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Breast / drug effects
  • Contraceptives, Oral, Combined / adverse effects
  • Contraceptives, Oral, Combined / standards*
  • Desogestrel / adverse effects
  • Desogestrel / standards
  • Drug Combinations
  • Estrogens / administration & dosage
  • Estrogens / adverse effects
  • Estrogens / standards*
  • Ethinyl Estradiol / adverse effects
  • Ethinyl Estradiol / standards
  • Female
  • Hormones / administration & dosage
  • Hormones / adverse effects
  • Hormones / standards
  • Humans
  • Menstrual Cycle / drug effects*
  • Menstrual Cycle / physiology
  • Middle Aged
  • Nausea / chemically induced
  • Norgestrel / adverse effects
  • Norgestrel / analogs & derivatives
  • Norgestrel / standards
  • Pregnancy
  • Statistics, Nonparametric
  • Uterine Hemorrhage / chemically induced

Substances

  • Contraceptives, Oral, Combined
  • Drug Combinations
  • Estrogens
  • Hormones
  • norgestimate, ethinyl estradiol drug combination
  • Norgestrel
  • Ethinyl Estradiol
  • Oviol
  • Desogestrel