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

Ian S. Fraser *University of Sydney, Sydney, New South Wales, Australia

Susanne ParkeGlobal Clinical Development, Bayer Pharma AG, Berlin, Germany

Uwe MellingerGlobal Clinical Development, Bayer Pharma AG, Berlin, Germany

Andrea MachlittGlobal Medical Affairs Women's Healthcare, Bayer Pharma AG, Berlin, Germany

Marco SerraniGlobal Medical Affairs Women's Healthcare, Bayer Pharma AG, Berlin, GermanyCorrespondence[email protected]

Jeffrey JensenOregon Health & Science University, Portland, OR, USA

Figures & data

Figure 1 Pooled flow of participants through two studies, one conducted in North America and the other in Europe and Australia.

Table 1 Demographic and baseline characteristics of women assigned to oestradiol valerate/dienogest (E₂V/DNG) or placebo

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Figure 2 Median menstrual blood loss (MBL) by treatment cycle in patients treated with oestradiol valerate/dienogest (E₂V/DNG) and placebo in (a) the intent-to-treat (ITT) population and (b) the subgroup of women with excessively heavy menstrual bleeding (defined as MBL greater than 80 ml at baseline; n = 227 for E₂V/DNG and n = 136 for placebo). *For comparative purposes, baseline was calculated as (MBL volume during the 90-day run-in phase/90) × 28. **MBL observed during treatment cycle 1 represents the physiological menstrual bleeding (which triggers the start of treatment) plus any intermenstrual bleeding that may have occurred. ***Total blood loss during 28-day treatment cycles.

Figure 2 Median menstrual blood loss (MBL) by treatment cycle in patients treated with oestradiol valerate/dienogest (E2V/DNG) and placebo in (a) the intent-to-treat (ITT) population and (b) the subgroup of women with excessively heavy menstrual bleeding (defined as MBL greater than 80 ml at baseline; n = 227 for E2V/DNG and n = 136 for placebo). *For comparative purposes, baseline was calculated as (MBL volume during the 90-day run-in phase/90) × 28. **MBL observed during treatment cycle 1 represents the physiological menstrual bleeding (which triggers the start of treatment) plus any intermenstrual bleeding that may have occurred. ***Total blood loss during 28-day treatment cycles.

Figure 3 Percentage change in menstrual blood loss (MBL) volume from baseline (90-day run-in phase) to the efficacy phase (90-day efficacy phase) experienced by the proportion of women (intent-to-treat [ITT]).

Figure 4 Absolute and relative reduction in menstrual blood loss (MBL) according to baseline MBL in the intent-to-treat (ITT) population. Data presented as (a) median reduction in MBL volume from baseline to treatment cycle 7 and (b) median percentage reduction from baseline to treatment cycle 7.

Table 2 Levels of haemoglobin, haematocrit and ferritin at baseline and day 196 of treatment in women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo

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Table 3 Adverse events that occurred in at least 2% of women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo (shown in alphabetical order)

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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

Table 1 Demographic and baseline characteristics of women assigned to oestradiol valerate/dienogest (E₂V/DNG) or placebo

Table 2 Levels of haemoglobin, haematocrit and ferritin at baseline and day 196 of treatment in women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo

Table 3 Adverse events that occurred in at least 2% of women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo (shown in alphabetical order)

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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

Figures & data

Table 1 Demographic and baseline characteristics of women assigned to oestradiol valerate/dienogest (E2V/DNG) or placebo

Table 2 Levels of haemoglobin, haematocrit and ferritin at baseline and day 196 of treatment in women who received oestradiol valerate/dienogest (E2V/DNG) or placebo

Table 3 Adverse events that occurred in at least 2% of women who received oestradiol valerate/dienogest (E2V/DNG) or placebo (shown in alphabetical order)

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Table 1 Demographic and baseline characteristics of women assigned to oestradiol valerate/dienogest (E₂V/DNG) or placebo

Table 2 Levels of haemoglobin, haematocrit and ferritin at baseline and day 196 of treatment in women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo

Table 3 Adverse events that occurred in at least 2% of women who received oestradiol valerate/dienogest (E₂V/DNG) or placebo (shown in alphabetical order)