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

NCT ID: NCT00195546

Last Updated: 2007-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-01-31

Brief Summary

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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

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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DVS-233

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Finland, Sweden, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Ukraine, Romania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belgium, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Czech Republic, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Hungary, Croatia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Mexico, [email protected]

Locations

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Leuven, , Belgium

Site Status

Zadar, , Croatia

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Zagreb, , Croatia

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Olomuc, , Czechia

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Ostrava, , Czechia

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Přerov, , Czechia

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Kuopio, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Évry, , France

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Paris, , France

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Paris, , France

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Debrecen, , Hungary

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Tatabánya, , Hungary

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Del. Cuauhtemoc, , Mexico

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Lomas Virrteyes, , Mexico

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's-Hertogenbosch, , Netherlands

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Hengelo, , Netherlands

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Nijmegen, , Netherlands

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Katowice, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bloemfontein, , South Africa

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Centurion, , South Africa

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Parow, , South Africa

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Madrid, , Spain

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Linköping, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Donetsk, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Fowey, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Plymouth, , United Kingdom

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Countries

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

Other Identifiers

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3151A2-321

Identifier Type: -

Identifier Source: org_study_id