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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195546
• Other study ID #: 3151A2-321
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 31, 2007
• Start date: April 2005
• Est. completion date: January 2006

Study information

• Verified date: May 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyMexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• DVS-233

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Belgium,  Croatia,  Czech Republic,  Finland,  France,  Hungary,  Mexico,  Netherlands,  Poland,  Romania,  South Africa,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.