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

Phase 3

Completed

• Conditions: Menopause

• Registration Number: NCT00195546
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2006-01
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-31
• Last Update Posted: 2007-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 465

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

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