Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
NCT00195546
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Adult Trials: 18+ Years
- 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.
- 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
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| Descriptive Information | ||||||||||||||||||||||||||||
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| 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 | 465 | |||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | January 2006 | |||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||||||||||||||||||||
| Sex/Gender ICMJE |
| |||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||