An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome

作者：Freeman Ellen W^*; Halbreich Uriel; Grubb Gary S; Rapkin Andrea J; Skouby Sven O; Smith Lynne; Mirkin Sebastian; Constantine Ginger D

来源：Contraception, 2012, 85(5): 437-445.

DOI：10.1016/j.contraception.2011.09.010

• Continuous
• Oral contraceptive
• Ethinyl estradiol
• Levonorgestrel
• Menstrual-related symptoms
• Premenstrual dysphoric disorder
• Premenstrual syndrome

Background: This article presents an overview of four studies that evaluated a continuous oral contraceptive (OC) containing levonorgestrel (90 mcg) and ethinyl estradiol (20 mcg; LNG/EE) for managing premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS).
Study Design: Three randomized, double-blind, placebo-controlled trials and one open-label, single-treatment substudy examined mean changes from baseline in the Daily Record of Severity of Problems (DRSP) or Penn Daily Symptom Rating (DSR).
Results: Improvements from baseline in mean DRSP and DSR scores were observed, but results were not consistent among the studies. Mean percent improvement of premenstrual symptoms ranged from 30% to 59% in controlled trials and 56% to 81% in an open-label substudy. A large placebo effect was also observed in the placebo-controlled studies. Continuous LNG/EE yielded a favorable safety profile.
Conclusions: These data, although not consistent, indicate that continuous LNG/EE may reduce the symptoms of PMDD and PMS, providing an option for women who are appropriate candidates for a continuous OC as a contraceptive, the approved indication for this medication.

• 出版日期2012-5