You are here

Our science / Clinical Trials / Find a Trial / NCT00195546

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

Back to Search Print Save as PDF Bookmark Trial

NCT00195546

Last updated on May 12, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Leuven, , 3000 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Menopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00195546
Pfizer
Completed
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Severe Vasomotor Symptom Associated With Menopause
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
NCT02792504
Females
20+
Years
Multiple Sites
Menopause, Vasomotor System
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
NCT00369434
Females
0+
Years
Multiple Sites
Postmenopause
Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.
NCT00195455
Females
45+
Years
Multiple Sites
Postmenopause
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
NCT00367536
Females
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Menopause
Drug: DVS-233
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
465
January 2006
Not Provided

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
Sexes Eligible for Study: Female
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Croatia,   Czech Republic,   Finland,   France,   Hungary,   Mexico,   Netherlands,   Poland,   Romania,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
 
 
NCT00195546
3151A2-321
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Finland, Sweden, [email protected]
Principal Investigator: Trial Manager For Ukraine, Romania, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For Czech Republic, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Principal Investigator: Trial Manager For Hungary, Croatia, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Mexico, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now