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

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Drug: DVS-233

• Study Type: Interventional
• Enrollment (Anticipated): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
• Croatia
  • Zadar, Croatia, 23000
  • Zagreb, Croatia, 10000
• Czech Republic
  • Olomuc, Czech Republic, 77200
  • Ostrava, Czech Republic, 70200
  • Prerov, Czech Republic, 75002
• Finland
  • Kuopio, Finland, 70100
  • Kuopio, Finland, 70110
  • Oulu, Finland, 90100
• France
  • Evry, France, 91024
  • Paris, France, 75012
  • Paris, France, 75005
• Hungary
  • Debrecen, Hungary, 4031
  • Tatabanya, Hungary, 2800
• Mexico
  • Del. Cuauhtemoc, Mexico, CP06727
  • Lomas Virrteyes, Mexico, CP11000
• Netherlands
  • Den Bosch, Netherlands, 5223 GV
  • Hengelo, Netherlands, 7555 PJ
  • Nijmegen, Netherlands, 6533 NV
• Poland
  • Katowice, Poland, 40-125
  • Poznan, Poland, 60-535
  • Warszawa, Poland, 02-341
  • Wroclaw, Poland, 50-088
• Romania
  • Bucuresti, Romania, 021659
  • Bucuresti, Romania, 050098
  • Bucuresti, Romania, 020475
  • Bucuresti, Romania, 060251
• South Africa
  • Bloemfontein, South Africa, 9301
  • Centurion, South Africa, 0157
  • Parow, South Africa, 7500
• Spain
  • Madrid, Spain, 28009
• Sweden
  • Linköping, Sweden, 58185
  • Stockholm, Sweden, 510401
  • Uppsala, Sweden, 75185
• Ukraine
  • Donetsk, Ukraine, 83114
  • Kyiv, Ukraine, 01034
  • Kyiv, Ukraine, 04112
• United Kingdom
  • Fowey, United Kingdom, PL23 1DT
  • Leicester, United Kingdom, LE2 7LX
  • London, United Kingdom, W12 0HS
  • Plymouth, United Kingdom, PL6 7TH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (LNMP) completed at least 12 months prior to screening.
• Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days
• Body Mass Index less than or equal to 34 kg/m2 using the nomograph for BMI.

Exclusion Criteria:

• History, presence, or suspicion of estrogen-dependent neoplasia; Malignancy, or treatment for malignancy, within the previous 2 years.
• Active or recent arterial thromboembolic disease; History of venous thromboembolism
• History of cerebrovascular accident, stroke, or transient ischemic attack -
• Presence of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy
• Persistent elevated blood pressure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Czech Republic, WPPGCLI@wyeth.com; Principal Investigator: Trial Manager, For Mexico, gomezlj@wyeth.com; Principal Investigator: Trial Manager, For Poland, WVWZMED@wyeth.com; Principal Investigator: Trial Manager, For Finland, Sweden, MedInfoNord@wyeth.com; Principal Investigator: Trial Manager, For Ukraine, Romania, WPVIMED@wyeth.com; Principal Investigator: Trial Manager, For Hungary, Croatia, WPBUMED@wyeth.com

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): June 1, 2007
• Last Update Submitted That Met QC Criteria: May 31, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Menopause
• Other Study ID Numbers: 3151A2-321