Low-dose Hormone Therapy for Relief of Vasomotor Symptoms | NCT00446199

ID	Type	Description	Link
310184	Other Identifier	Company internal

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.5mg DRSP / 0.5mg E2 (BAY86-4891)	Experimental	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).	Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
0.25mg DRSP / 0.5mg E2 (BAY86-4891)	Experimental	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).	Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
Estradiol (E2 0.3mg)	Experimental	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).	Drug: Estradiol (E2 0.3mg)
Placebo	Placebo Comparator	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5mg DRSP / 0.5mg E2 (BAY86-4891)	Drug	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).	0.5mg DRSP / 0.5mg E2 (BAY86-4891)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)	Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.	Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)	Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.	Baseline until 4 weeks of treatment
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)	Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.	Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)	Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in Vaginal pH	Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.	Baseline until 12 weeks of treatment
Change From Baseline to Week 12 in Vaginal Maturation Value

Other Outcomes

Measure	Description	Time Frame
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)	Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.	Baseline until 12 weeks of treatment

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

PubMed Identifier	Type	Citation	Retractions
23963309	Result	Sutter G, Schmelter T, Gude K, Schaefers M, Gerlinger C, Archer DF. Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17beta-estradiol in postmenopausal women with moderate to severe vasomotor symptoms. Menopause. 2014 Mar;21(3):236-42. doi: 10.1097/GME.0b013e31829c12e8.
23963307	Result

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
FG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
BG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
BG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
BG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The population included all randomized participants with Baseline VMS data and at least 1 day VMS data postdose. Full Analysis Set (FAS).

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.8± 5.61 BG00153.5± 5.77 BG00253.3± 6.05 BG003

Sex: Female, Male

The population included all randomized participants with Baseline VMS data and at least 1 day VMS data postdose. Full Analysis Set (FAS).

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000178 BG001177

Number of participants with hysterectomy/oophorectomy

The population included all randomized participants with Baseline VMS data and at least 1 day VMS data postdose. Full Analysis Set (FAS).

Number

Participants

Title

Denominators

Categories

hysterectomized

Title	Measurements
	BG00098 BG00191

Body Mass Index (BMI)

The population included all randomized participants with Baseline VMS data and at least 1 day VMS data postdose. Full Analysis Set (FAS).

Mean

Standard Deviation

kg/sqm

Title

Denominators

Categories

Title	Measurements
	BG00029.070± 6.0636 BG00128.190

Years since last menstruation at baseline

The population included all randomized participants with Baseline VMS data and at least 1 day VMS data postdose. Full Analysis Set (FAS).

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.913± 8.6719 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.

Full analysis set (Intention to Treat (ITT)) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Median

Full Range

Hot Flushes per week

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Units	Counts
Participants	OG000177 OG001175 OG002178 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-54.515(-324.6 to 60.82) OG001-54.125(-215.9 to 9.03) OG002-44.389(-145.4 to 91.25) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.	Wilcoxon/van Elteren	stratification by center	<0.0001	significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.						95						No	Superiority or Other

Primary

Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Median

Full Range

Hot Flushes per week

Baseline until 4 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003

Primary

Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Median

Full Range

Scores on a scale

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)

Primary

Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Median

Full Range

Scorese on a scale

Baseline until 4 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)

Secondary

Change From Baseline to Week 12 in Vaginal pH

Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.

Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.

Posted

Mean

Standard Deviation

(pH)

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Change From Baseline to Week 12 in Vaginal Maturation Value

Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.

Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.

Posted

Mean

Standard Deviation

Percentages of cells

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'

Subjects self-assessed symptom severity

Full analysis set. Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'

Subjects self-assessed symptom severity

Full analysis set. Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'

Subjects self-assessed symptom severity

Full analysis set. Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'

Subjects self-assessed symptom severity

Full analysis set. Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'

Subjects self-assessed symptom severity

Full analysis set. Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'

Subjects self-assessed presence or absence of symptom

Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'

Subjects self-assessed presence or absence of symptom

Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Secondary

Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'

Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.

Full analysis set (ITT). Numbers differ from the complete full analysis set due to missing data.

Posted

Number

participants

After 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

Other Pre-specified

Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Mean

Standard Deviation

Hot Flushes per week

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003

Other Pre-specified

Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Mean

Standard Deviation

Hot Flushes per week

Baseline until 4 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
OG003

Other Pre-specified

Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline until 12 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)

Other Pre-specified

Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)

Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.

Full analysis set (ITT) with last observation carried forward approach (LOCF). Numbers differ from the complete full analysis set due to missing Week 1 data.

Posted

Mean

Standard Deviation

scores on a scale

Baseline until 4 weeks of treatment

ID	Title	Description
OG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
OG002	Estradiol (E2 0.3mg)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.5mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).	0	181	80	181
EG001	0.25mg DRSP / 0.5mg E2 (BAY86-4891)	One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).	1	183	75	183
EG002	Estradiol (E2 0.3mg)	One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)	3	182	68	182
EG003	Placebo	Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).	1	180	64	180

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Salpingitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0011 affected183 at risk EG0020 affected182 at risk EG0030 affected180 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0010 affected183 at risk EG0020 affected182 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0010 affected183 at risk EG0021 affected182 at risk EG003
Oropharyngeal cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0010 affected183 at risk EG0021 affected182 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0010 affected183 at risk EG0021 affected182 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0010 affected183 at risk EG0021 affected182 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0005 affected181 at risk EG0016 affected183 at risk EG0026 affected182 at risk EG0032 affected180 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0018 affected183 at risk EG0025 affected182 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0014 affected183 at risk EG0022 affected182 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0010 affected183 at risk EG0023 affected182 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0005 affected181 at risk EG0010 affected183 at risk EG0020 affected182 at risk EG003
Oedema peripheral	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0014 affected183 at risk EG0020 affected182 at risk EG003
Vaginitis bacterial	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0007 affected181 at risk EG0013 affected183 at risk EG0027 affected182 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0016 affected183 at risk EG0024 affected182 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0005 affected181 at risk EG0014 affected183 at risk EG0023 affected182 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0006 affected181 at risk EG0013 affected183 at risk EG0024 affected182 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0015 affected183 at risk EG0024 affected182 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0015 affected183 at risk EG0021 affected182 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0017 affected183 at risk EG0027 affected182 at risk EG003
C-reactive protein increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0016 affected183 at risk EG0023 affected182 at risk EG003
Blood glucose increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0012 affected183 at risk EG0023 affected182 at risk EG003
Blood cholesterol increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0013 affected183 at risk EG0024 affected182 at risk EG003
Blood triglycerides increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0012 affected183 at risk EG0021 affected182 at risk EG003
Weight decreased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0012 affected183 at risk EG0022 affected182 at risk EG003
Weight increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0014 affected183 at risk EG0021 affected182 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected181 at risk EG0012 affected183 at risk EG0020 affected182 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0007 affected181 at risk EG0012 affected183 at risk EG0024 affected182 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0014 affected183 at risk EG0021 affected182 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0006 affected181 at risk EG0015 affected183 at risk EG0023 affected182 at risk EG003
Headache	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0008 affected181 at risk EG00111 affected183 at risk EG00210 affected182 at risk EG003
Mood swings	Psychiatric disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0012 affected183 at risk EG0022 affected182 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected181 at risk EG0018 affected183 at risk EG0025 affected182 at risk EG003
Breast tenderness	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG00012 affected181 at risk EG0016 affected183 at risk EG0021 affected182 at risk EG003
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0013 affected183 at risk EG0025 affected182 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0012 affected183 at risk EG0021 affected182 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0004 affected181 at risk EG0010 affected183 at risk EG0021 affected182 at risk EG003
Hypertension	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected181 at risk EG0011 affected183 at risk EG0024 affected182 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36608	United States

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists