Phase 3 N=2,186 Randomized Triple-blind Treatment

Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

Vasomotor Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT00683800 ↗

Enrolled (actual)

2,186

Serious AEs

3.7%

Results posted

Aug 2011

Primary outcome: Primary: Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4 — -6.52; -3.64 Hot Flushes — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: desvenlafaxine succinate (DVS) SR (Drug); Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Pfizer
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 4	-6.52; -3.64	<0.001 sig
PRIMARY Change From Baseline in the Average Daily Number of Moderate to Severe Hot Flushes at Week 12	-7.31; -4.52	<0.001 sig
PRIMARY Change From Baseline in the Average Daily Severity of Hot Flushes at Week 4	-0.47; -0.19	<0.001 sig
PRIMARY Change From Baseline in the Average Daily Severity of Hot Flushes at Week 12	-0.59; -0.28	<0.001 sig
PRIMARY Number of Participants With All Adjudicated Ischemic Cardiovascular (CV) Events	0; 1; 0; 0; 0; 1	—
SECONDARY Number of Participants With a Minimal Clinically Meaningful Decrease in the Average Daily Number of Hot Flushes	117; 75	<0.001 sig
SECONDARY Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes	58.47; 28.89; 67.93; 44.20	<0.001 sig
SECONDARY Percentage of Participants With at Least 75% Reduction From Baseline in the Number of Moderate and Severe Hot Flushes	32.79; 10.00; 41.30; 18.23	<0.001 sig
SECONDARY Median Time to the First Day of 3 Consecutive Days of at Least 50% Reduction in Hot Flushes	13.0; 48.0	<0.001 sig
SECONDARY Change From Baseline in Adjusted Means in the Number of Moderate and Severe Hot Flushes at Month 6 and Month 12	-8.65; -6.61; -7.98; -5.17	<0.001 sig
SECONDARY Change From Baseline in Adjusted Means in the Hot Flush Severity Score at Month 6 and Month 12	-0.87; -0.56; -0.78; -0.45	0.002 sig
SECONDARY Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Week 12	22.48; 22.04; 6.43; 6.36; 4.92; 4.84	<0.001 sig
SECONDARY Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 6	-9.84; -7.97; -3.06; -2.41; -2.35; -1.77	<0.001 sig
SECONDARY Change From Baseline in the Total Greene Climacteric Scale (GCS) Score and GCS Subscores at Month 12	-10.60; -8.89; -3.25; -2.69; -2.66; -2.04	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Week 12	8.8; 5.0; 27.8; 18.5; 28.9; 26.5	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 6	8.5; 5.7; 32.2; 25.5; 27.3; 23.1	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for Main Study Efficacy Population at Month 12	10.1; 7.1; 32.2; 27.8; 25.9; 21.0	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Week 12	8.1; 1.7; 20.3; 10.9; 29.1; 16.6	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 6	12.2; 2.9; 29.7; 18.3; 27.3; 17.7	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Symptom Rating (PGI-R) for MITT Population of Efficacy Substudy at Month 12	9.3; 4.0; 28.5; 17.1; 26.7; 12.6	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Week 12	25.8; 13.1; 32.3; 25.5; 23.3; 25.1	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 6	28.9; 17.1; 32.3; 27.7; 20.5; 20.6	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for Main Study Efficacy Population at Month 12	31.0; 19.9; 29.2; 24.5; 21.1; 21.5	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Week 12	26.7; 7.4; 35.5; 22.3; 17.4; 29.7	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 6	34.9; 14.9; 32.6; 25.7; 15.7; 23.4	<0.001 sig
SECONDARY Percentage of Participants With Categorical Scores Based on Patient Global Impression Change (PGI-C) for MITT Population of Efficacy Substudy at Month 12	37.2; 13.7; 24.4; 18.3; 21.5; 25.1	<0.001 sig

Summary

The purpose of the study is to evaluate the efficacy and safety of Desvenlafaxine Succinate (DVS) Sustained Release (SR), in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) in menopausal women.

Eligibility Criteria

Inclusion Criteria

Generally healthy, postmenopausal women who seek treatment for hot flushes
Body Mass Index (BMI) less than or equal to 34 kg/m^2

Exclusion Criteria

Hypersensitivity to Venlafaxine
Myocardial infarction an/or unstable angina within 6 months of screening
History of seizure disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00683800). 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.