Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Summary

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Timeline

Start

2005-12

Primary completion

2008-05

Completion

2008-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) vs Placebo; p < 0.0001; inverting 2 one-sided tests NCT00293059 ↗

paper significantly higher in E2 valerate and dienogest (35/80; 43.8%) compared with placebo (2/48, 4.2%, P<.001) PMID 21422847 ↗

Publications

• Results Fraser IS, Jensen J, Schaefers M, Mellinger U, Parke S, Serrani M. Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception. 2012 Aug;86(2):96-101. doi: 10.1016/j.contraception.2011.11.011. Epub 2012 Jan 10.
• Results Jensen JT, Parke S, Mellinger U, Machlitt A, Fraser IS. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):777-787. doi: 10.1097/AOG.0b013e3182118ac3.
• Results Fraser IS, Parke S, Mellinger U, Machlitt A, Serrani M, Jensen J. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest. Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258-69. doi: 10.3109/13625187.2011.591456.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	3 mg	Oral
Subject	estradiol valerate	Unknown	2 mg	Oral

Indications