MenopausePhase 3NCT00195546
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
A Phase 3 study testing DVS-233 in people with Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- DVS-233
- How many people
- 465 participants
- Where
- 41 sitesin 15 countries
- Study dates
- Apr 2005to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
41 sites in 15 countries.
41 sites in 15 countries
Poland4 sites
Study site
Katowice, 40-125
Study site
Poznan, 60-535
Study site
Warsaw, 02-341
Study site
Wroclaw, 50-088
Romania4 sites
Study site
Bucharest, 020475
Study site
Bucharest, 021659
Study site
Bucharest, 050098
Study site
Bucharest, 060251
United Kingdom4 sites
Study site
Fowey, PL23 1DT
Study site
Leicester, LE2 7LX
Study site
London, W12 0HS
Study site
Plymouth, PL6 7TH
Czechia3 sites
Study site
Olomuc, 77200
Study site
Ostrava, 70200
Study site
Přerov, 75002
Finland3 sites
Study site
Kuopio, 70100
Study site
Kuopio, 70110
Study site
Oulu, 90100
France3 sites
Study site
Évry, 91024
Study site
Paris, 75005
Study site
Paris, 75012
Netherlands3 sites
Study site
's-Hertogenbosch, 5223 GV
Study site
Hengelo, 7555 PJ
Study site
Nijmegen, 6533 NV
South Africa3 sites
Study site
Bloemfontein, 9301
Study site
Centurion, 0157
Study site
Parow, 7500
Sweden3 sites
Study site
Linköping, 58185
Study site
Stockholm, 510401
Study site
Uppsala, 75185
Ukraine3 sites
Study site
Donetsk, 83114
Study site
Kyiv, 01034
Study site
Kyiv, 04112
Mexico2 sites
Study site
Del. Cuauhtemoc, CP06727
Study site
Lomas Virrteyes, CP11000
About this study
Official title: 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.
- Conditions
- Menopause
- Being tested
- DVS-233
- Keywords
- Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVS-233Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Finland, Sweden, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Ukraine, Romania, WPVIMED@wyeth.comTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.comTrial Manager, Principal investigator, For Czech Republic, WPPGCLI@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Manager, Principal investigator, For Hungary, Croatia, WPBUMED@wyeth.comTrial Manager, Principal investigator, For Poland, WVWZMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195546
- Sponsor's protocol ID
- 3151A2-321
- Status last verified
- May 2007
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause
- ClinicalTrials.gov ID
- NCT00195546
- Acronym / sponsor ID
- 3151A2-321
- Conditions
- Menopause
- Keywords
- Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jan 2006 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVS-233 | Drug | – |
Primary outcome
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.
1 secondary outcome
To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Finland, Sweden, MedInfoNord@wyeth.com
Trial Manager principal investigator
For Ukraine, Romania, WPVIMED@wyeth.com
41 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DVS-233 in people with Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 41 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Poland, Romania, United Kingdom, Czechia, Finland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2007.