Status:
COMPLETED
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2006
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT00195546
Start Date
April 1 2005
End Date
January 1 2006
Last Update
June 1 2007
Active Locations (41)
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1
Leuven, Belgium, 3000
2
Zadar, Croatia, 23000
3
Zagreb, Croatia, 10000
4
Olomuc, Czechia, 77200