Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder.

Abstract

BACKGROUND:

The study was conducted to investigate continuous daily levonorgestrel 90 mcg/ethinyl estradiol 20 mcg (LNG/EE) on premenstrual dysphoric disorder (PMDD).

STUDY DESIGN:

In this multicenter, randomized, double-blind, placebo-controlled study, women with PMDD received LNG/EE (n=186) or placebo (n=181) daily for 112 days and completed the Daily Record of Severity of Problems (DRSP).

RESULTS:

Mean DRSP change from baseline to late luteal phase was significantly greater with LNG/EE than placebo at the late luteal phase of the first estimated cycle (-30.52±1.73 [SE] vs. -22.47±1.77; p<.001) and the worst 5 days during the last on-therapy estimated cycle (-26.77±1.83 vs. -20.89±1.82; p=.016). Other primary end points were not statistically significant. Significantly more subject taking LNG/EE (52%) than placebo (40%) responded (≥50% improvement in the DRSP 7-day late luteal phase score and Clinical Global Impression of Severity score of ≥1 improvement) at last on-therapy cycle (p=.025).

CONCLUSIONS:

Continuous daily LNG 90 mcg/EE 20 mcg was well tolerated and may be useful for managing the physical, psychological and behavioral symptoms and loss of work productivity related to PMDD.

• Authors: Uriel Halbreich, Ellen W Freeman, Andrea J Rapkin, Lee S Cohen, Gary S Grubb, Richard Bergeron, Lynne Smith, Sebastian Mirkin, Ginger D Constantine
• Journal: Contraception (Contraception) Vol. 85 Issue 1 Pg. 19-27 (Jan 2012) ISSN: 1879-0518 [Electronic] United States
• PMID: 22067793 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Contraceptive Agents, Female
• Estrogens
• Ethinyl Estradiol
• Levonorgestrel

Topics

• Adolescent
• Adult
• Contraceptive Agents, Female (administration & dosage, adverse effects)
• Double-Blind Method
• Estrogens (administration & dosage, adverse effects)
• Ethinyl Estradiol (administration & dosage, adverse effects)
• Female
• Humans
• Levonorgestrel (administration & dosage, adverse effects)
• Middle Aged
• Premenstrual Syndrome (drug therapy)
• Treatment Outcome
• Young Adult