Clinical trial NCT00195546: Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Keywords: Menopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 465
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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 outcomes:
measure: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
Other outcomes:
Locations:
city: Leuven
country: Belgium
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Olomuc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Prerov
country: Czech Republic
city: Kuopio
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Evry
country: France
city: Paris
country: France
city: Paris
country: France
city: Debrecen
country: Hungary
city: Tatabanya
country: Hungary
city: Del. Cuauhtemoc
country: Mexico
city: Lomas Virrteyes
country: Mexico
city: Den Bosch
country: Netherlands
city: Hengelo
country: Netherlands
city: Nijmegen
country: Netherlands
city: Katowice
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bloemfontein
country: South Africa
city: Centurion
country: South Africa
city: Parow
country: South Africa
city: Madrid
country: Spain
city: Linköping
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Donetsk
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Fowey
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Finland, Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Ukraine, Romania, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Czech Republic, WPPGCLI@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, Croatia, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WVWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: