Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195546
First received: September 13, 2005
Last updated: May 31, 2007
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause |
Drug: DVS-233 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- 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 Outcome Measures:
- To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
| Estimated Enrollment: | 465 |
| Study Start Date: | April 2005 |
| Study Completion Date: | January 2006 |
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195546
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| Belgium | |
| Leuven, Belgium, 3000 | |
| Croatia | |
| Zadar, Croatia, 23000 | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Olomuc, Czech Republic, 77200 | |
| Ostrava, Czech Republic, 70200 | |
| Prerov, Czech Republic, 75002 | |
| Finland | |
| Kuopio, Finland, 70110 | |
| Kuopio, Finland, 70100 | |
| Oulu, Finland, 90100 | |
| France | |
| Evry, France, 91024 | |
| Paris, France, 75012 | |
| Paris, France, 75005 | |
| Hungary | |
| Debrecen, Hungary, 4031 | |
| Tatabanya, Hungary, 2800 | |
| Mexico | |
| Del. Cuauhtemoc, Mexico, CP06727 | |
| Lomas Virrteyes, Mexico, CP11000 | |
| Netherlands | |
| Den Bosch, Netherlands, 5223 GV | |
| Hengelo, Netherlands, 7555 PJ | |
| Nijmegen, Netherlands, 6533 NV | |
| Poland | |
| Katowice, Poland, 40-125 | |
| Poznan, Poland, 60-535 | |
| Warszawa, Poland, 02-341 | |
| Wroclaw, Poland, 50-088 | |
| Romania | |
| Bucuresti, Romania, 021659 | |
| Bucuresti, Romania, 050098 | |
| Bucuresti, Romania, 020475 | |
| Bucuresti, Romania, 060251 | |
| South Africa | |
| Bloemfontein, South Africa, 9301 | |
| Centurion, South Africa, 0157 | |
| Parow, South Africa, 7500 | |
| Spain | |
| Madrid, Spain, 28009 | |
| Sweden | |
| Linköping, Sweden, 58185 | |
| Stockholm, Sweden, 510401 | |
| Uppsala, Sweden, 75185 | |
| Ukraine | |
| Donetsk, Ukraine, 83114 | |
| Kyiv, Ukraine, 01034 | |
| Kyiv, Ukraine, 04112 | |
| United Kingdom | |
| Fowey, United Kingdom, PL23 1DT | |
| Leicester, United Kingdom, LE2 7LX | |
| London, United Kingdom, W12 0HS | |
| Plymouth, United Kingdom, PL6 7TH | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Finland, Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Ukraine, Romania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For Czech Republic, WPPGCLI@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
| Principal Investigator: | Trial Manager | For Hungary, Croatia, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WVWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Mexico, gomezlj@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00195546 History of Changes |
| Other Study ID Numbers: | 3151A2-321 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 31, 2007 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency Mexico: Federal Commission for Protection Against Health Risks |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Menopause |
ClinicalTrials.gov processed this record on May 16, 2013