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

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NCT00195546

Last updated on April 4, 2020
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Study Location
Leuven, , 3000 Belgium
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE Drug: DVS-233
Study Arms  ICMJE Not Provided
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005) 		465
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Croatia,   Czech Republic,   Finland,   France,   Hungary,   Mexico,   Netherlands,   Poland,   Romania,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195546
Other Study ID Numbers  ICMJE 3151A2-321
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2007

ICMJE     Data element required by the

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

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