Vasomotor Symptoms Associated With MenopausePhase 3NCT00234819
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
A Phase 3 study testing Bazedoxifene/Conjugated Estrogen in people with Vasomotor Symptoms Associated With Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Vasomotor Symptoms Associated With Menopause
- What is being tested?
- Bazedoxifene/Conjugated Estrogen
- How many people
- 325 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2005to Feb 2007
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
- Intact uterus
- Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week
Who cannot join
- History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
- History of active presence of stroke, TIA, heart attack or ischemic heart disease
- History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Fort Myers, Florida, 33916
Study site
North Port Richey, Florida, 34652
Study site
Phoenix, Arizona, 85105
Study site
Pottstown, Pennsylvania, 19464
Study site
Scarborough, Maine, 04074
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
- Being tested
- Bazedoxifene/Conjugated Estrogen
- Keywords
- Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene/Conjugated EstrogenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
Secondary outcomes (1)
Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasomotor Symptoms Associated With 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
- 325 participants
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 Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234819
- Sponsor's protocol ID
- 3115A1-305
- Status last verified
- Dec 2007
- First submitted
- 5 Oct 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
Publications
Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
PubMed 27676118
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogen Combinations for Treatment of Vasomotor Symptoms Associated With Menopause
- ClinicalTrials.gov ID
- NCT00234819
- Acronym / sponsor ID
- 3115A1-305
- Keywords
- Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 7 Oct 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.
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
- Intact uterus
- Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week
Key exclusion criteria (3 listed)
- History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
- History of active presence of stroke, TIA, heart attack or ischemic heart disease
- History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
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 |
|---|---|---|
| Bazedoxifene/Conjugated Estrogen | Drug | – |
Primary outcome
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.
1 secondary outcome
Breast pain throughout the 12 week study, as reported daily on subject diary cards. Sleep scales and sleep quantity at week 4 and week 12, as indicated on a subject-completed questionnaire.
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 28 Dec 2007.
- Derived from this study: PubMed 27676118Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bazedoxifene/Conjugated Estrogen in people with Vasomotor Symptoms Associated With Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 7 sites in United States.
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 3 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Number and severity of moderate and severe hot flashes at week 4 and at week 12, as reported daily on subject diary cards.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00234819, which also lists 1 linked publication.
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 28 Dec 2007.