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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195546
First Posted: September 19, 2005
Last Update Posted: June 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
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.

Condition Intervention Phase
Menopause Drug: DVS-233 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 465
Study Start Date: April 2005
Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195546


  Show 41 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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 Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Hungary, Croatia, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Poland, WVWZMED@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezlj@wyeth.com
  More Information

ClinicalTrials.gov Identifier: NCT00195546     History of Changes
Other Study ID Numbers: 3151A2-321
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: June 1, 2007
Last Verified: May 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause