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

Wyeth is now a wholly owned subsidiary of Pfizer0 sites465 target enrollmentApril 2005

ConditionsMenopause

DrugsDVS-233

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Menopause
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 465
Primary Endpoint: 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.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

January 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility 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

Outcomes

Primary Outcomes

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.