Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest

A randomized controlled trial

Jeffrey Jensen, Susanne Parke, Uwe Mellinger, Andrea MacHlitt, Ian S. Fraser

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Objective: To estimate the efficacy of a fixed estrogen step-down and progestin step-up 28-day estradiol (E2) valerate and dienogest oral contraceptive regimen in women with heavy menstrual bleeding, prolonged menstrual bleeding, or heavy and prolonged menstrual bleeding without organic pathology. Methods: This double-blind, placebo-controlled study randomized women aged 18 years or older with prolonged, frequent, or heavy menstrual bleeding, objectively confirmed during a 90-day run-in phase, to treatment with E2 valerate and dienogest or placebo (2:1) for 196 days. Data from the last 90 days of treatment and the run-in phase were compared. The primary variable was the "complete response" rate (complete resolution of qualifying abnormal menstrual symptoms, including a 50% or greater reduction in pretreatment menstrual blood loss volume in women with heavy menstrual bleeding). Secondary variables included objective changes in menstrual blood loss volume (alkaline hematin methodology) and iron metabolism parameters. Overall, 180 women were needed to provide 90% power. Results: There were no marked differences in the characteristics of E2 valerate and dienogest (n=120) and placebo (n=70) recipients. The proportion of "complete responders" in the evaluable group was significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P

Original languageEnglish (US)
Pages (from-to)777-787
Number of pages11
JournalObstetrics and Gynecology
Volume117
Issue number4
DOIs
StatePublished - Apr 2011

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dienogest
Valerates
Randomized Controlled Trials
Hemorrhage
Placebos
Blood Volume
Therapeutics
Hemin
Progestins
Oral Contraceptives
Double-Blind Method
Estrogens
Iron
estradiol valerate-dienogest
Pathology

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest : A randomized controlled trial. / Jensen, Jeffrey; Parke, Susanne; Mellinger, Uwe; MacHlitt, Andrea; Fraser, Ian S.

In: Obstetrics and Gynecology, Vol. 117, No. 4, 04.2011, p. 777-787.

Research output: Contribution to journalArticle

Jensen, Jeffrey ; Parke, Susanne ; Mellinger, Uwe ; MacHlitt, Andrea ; Fraser, Ian S. / Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest : A randomized controlled trial. In: Obstetrics and Gynecology. 2011 ; Vol. 117, No. 4. pp. 777-787.
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