Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest.

Abstract

BACKGROUND:

The study was conducted to assess the efficacy of estradiol valerate/dienogest (E₂V/DNG) administered using an estrogen step-down and progestogen step-up approach in a 28-day regimen in the treatment of heavy menstrual bleeding (HMB) using clinical end points allowing E₂V/DNG to be compared with other available medical therapies.

STUDY DESIGN:

This was a pooled analysis of data from two identically designed randomized, placebo-controlled, multiple center studies conducted in Europe, Australia and North America that assessed the effectiveness of E₂V/DNG in reducing menstrual blood loss (MBL) in women with HMB. Women aged ≥ 18 years with objectively confirmed HMB were randomized to E₂V/DNG (n=220) or placebo (n=135) for seven treatment cycles. Outcomes analyzed included absolute reduction in MBL from baseline, proportion of women successfully treated (defined as MBL below 80 mL and ≥ 50% reduction in MBL), proportion with MBL below 80 mL and proportion with ≥ 50% reduction in MBL from baseline.

RESULTS:

At study end, 63.6% and 11.9% of patients were successfully treated with E₂V/DNG and placebo, respectively, with 68.2% and 15.6% of women with MBL below 80 mL, and 70.0% and 17.0% with MBL reduction ≥ 50% (all p<.001).

CONCLUSION:

E₂V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.

• Authors: Ian S Fraser, Jeffrey Jensen, Matthias Schaefers, Uwe Mellinger, Susanne Parke, Marco Serrani
• Journal: Contraception (Contraception) Vol. 86 Issue 2 Pg. 96-101 (Aug 2012) ISSN: 1879-0518 [Electronic] United States
• PMID: 22240178 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Inc. All rights reserved.

Chemical References

• Androgens
• Contraceptives, Oral, Combined
• Contraceptives, Oral, Hormonal
• Drug Combinations
• Estrogens
• estradiol valerate-dienogest
• Estradiol
• Nandrolone

Topics

• Adolescent
• Adult
• Androgens (administration & dosage, adverse effects, therapeutic use)
• Contraceptives, Oral, Combined (administration & dosage, adverse effects, therapeutic use)
• Contraceptives, Oral, Hormonal (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Estradiol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Estrogens (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Intention to Treat Analysis
• Menorrhagia (drug therapy)
• Middle Aged
• Nandrolone (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Randomized Controlled Trials as Topic
• Treatment Outcome
• Young Adult