Trial record 9 of 1190 for:    menopause

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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195546
First received: September 13, 2005
Last updated: May 31, 2007
Last verified: May 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00195546     History of Changes
Other Study ID Numbers: 3151A2-321
Study First Received: September 13, 2005
Last Updated: May 31, 2007
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks

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

ClinicalTrials.gov processed this record on October 22, 2014