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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Leuven, , 3000 Belgium
Contact
1-800-718-1021
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

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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.

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1-800-718-1021

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[email protected]



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