Phase 3 N=735 Randomized Double-blind Treatment

Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

Vasomotor Symptoms · Hot Flashes

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View on ClinicalTrials.gov: NCT00446199 ↗

Enrolled (actual)

735

Serious AEs

0.7%

Results posted

Apr 2012

Primary outcome: Primary: Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value) — -54.515; -54.125; -44.389; -30.020 Hot Flushes per week — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) (Drug); 0.25mg DRSP / 0.5mg E2 (BAY86-4891) (Drug); Estradiol (E2 0.3mg) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)	-54.515; -54.125; -44.389; -30.020	<0.0001 sig
PRIMARY Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)	-46.868; -37.596; -31.621; -15.109	<0.0001 sig
PRIMARY Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)	-1.9294; -1.000; -0.2638; -0.0698	<0.0001 sig
PRIMARY Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)	-0.2905; -0.1821; -0.0651; 0.0000	<0.0001 sig
SECONDARY Change From Baseline to Week 12 in Vaginal pH	-0.63; -0.63; -0.66; -0.06	<0.0001 sig
SECONDARY Change From Baseline to Week 12 in Vaginal Maturation Value	10.07; 11.71; 7.69; -2.41	<0.0001 sig
SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'	83; 70; 71; 70; 59; 52	0.0314 sig
SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'	152; 140; 146; 128; 20; 24	0.0027 sig
SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'	166; 169; 167; 153; 6; 2	0.4397
SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'	128; 132; 127; 118; 21; 22	0.9555
SECONDARY Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'	164; 162; 159; 151; 2; 2	0.8966
SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'	45; 56; 62; 57	0.1067
SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'	70; 53; 53; 48	0.0144 sig
SECONDARY Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'	99; 114; 114; 111	0.2179

Summary

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Eligibility Criteria

Inclusion Criteria

Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria

The usual exclusion criteria for hormone therapy apply
Intake of medications other than hormones affecting hot flushes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00446199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.