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Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

NCT00195546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2007-06-01

No results posted yet for this study

Summary

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

Conditions

Interventions

DRUG

DVS-233

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Completion
2006-01-31

Countries

  • Belgium
  • Croatia
  • Czechia
  • Finland
  • France
  • Hungary
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • South Africa
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00195546 on ClinicalTrials.gov