Vaginal AtrophyPhase 3NCT00238732
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
A Phase 3 study testing Bazedoxifene/Conjugated Estrogen in people with Vaginal Atrophy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 63 sites in United States.
Trial summary
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- Bazedoxifene/Conjugated Estrogen
- How many people
- 650 participants
- Where
- 63 sitesUnited States
- Study dates
- Oct 2005to Mar 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy, postmenopausal women, aged 40 to 65 years
- Intact uterus
- At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome
Who cannot join
- Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
- Thrombophlebitis, thrombosis or thromboembolic disorders
- Neuro-ocular disease
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia, 30328
Study site
Aventura, Florida, 33180
Study site
Avon, Connecticut
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Booklyn Center, Minnesota
Study site
Burlington, Vermont
Study site
Champaign, Illinois
Study site
Chaska, Minnesota
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Conyers, Georgia
Study site
Creve Cour, Missouri
Study site
Dallas, Texas
Study site
Denton, Texas
Study site
Denver, Colorado, 80202
Study site
Douglasville, Georgia
Study site
Erie, Pennsylvania
Study site
Fargo, North Dakota
Study site
Gainesville, Florida
Study site
Galveston, Texas
Study site
Groton, Connecticut
Study site
Hilton Head Island, South Carolina
Study site
Idaho Falls, Idaho
Study site
Jackson, Mississippi
Study site
Jamestown, North Dakota
Study site
Kansas, Mississippi
Study site
Kansas City, Kansas
Study site
Lebanon, New Hampshire
Study site
Livingston, New Jersey
Study site
Medford, Oregon
Study site
Media, Pennsylvania
Study site
Miami, Florida
Study site
Montgomery, Alabama
Study site
Nashville, Tennessee
Study site
New Brunswick, New Jersey
Study site
Norfolk, Virginia
Study site
Oakland, California
Study site
Oklahoma City, Oklahoma
Study site
Palm Harbor, Florida
Study site
Palm Springs, Florida
Study site
Pinnellas Park, Florida
Study site
Richmond, Virginia
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Savannah, Georgia
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
Shreveport, Louisiana
Study site
Sioux Falls, South Dakota
Study site
St Louis, Missouri
Study site
Stuart, Florida
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Upland, California, 91786
Study site
Waterbury, Connecticut
Study site
West Palm Beach, Florida
Study site
West Reading, Pennsylvania
Study site
Winston-Salem, North Carolina
About this study
Official title: A Double-Blind, Randomized, Placebo-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
- Conditions
- Vaginal Atrophy
- Being tested
- Bazedoxifene/Conjugated Estrogen
- Keywords
- Vaginal Atrophy, Postmenopause
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.
Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Secondary outcomes (2)
Vaginal pH at screening, and weeks 4 and 12.
Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startOct 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginal AtrophyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 650 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
- NCT00238732
- Sponsor's protocol ID
- 3115A1-306
- Status last verified
- Dec 2007
- First submitted
- 12 Oct 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
Publications
Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.
PubMed 37619252Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.
PubMed 28539177
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-and Active-Controlled Efficacy and Safety Study of Bazedoxifene/Conjugated Estrogens Combinations for Treatment of Moderate to Severe Vulvar/Vaginal Atrophy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00238732
- Acronym / sponsor ID
- 3115A1-306
- Conditions
- Vaginal Atrophy
- Keywords
- Vaginal Atrophy, Postmenopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 13 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 Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.
Study design
- Primary purpose
- Diagnosis
- 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)
- Generally healthy, postmenopausal women, aged 40 to 65 years
- Intact uterus
- At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome
Key exclusion criteria (3 listed)
- Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
- Thrombophlebitis, thrombosis or thromboembolic disorders
- Neuro-ocular disease
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
Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.
2 secondary outcomes
Vaginal pH at screening, and weeks 4 and 12.
Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.
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 37619252Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.
- Derived from this study: PubMed 28539177Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.
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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
63 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 Vaginal Atrophy, run by Wyeth is now a wholly owned subsidiary of Pfizer at 63 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 63 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?
Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.. The study lists 2 primary outcomes in all. 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 NCT00238732, which also lists 2 linked publications.
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.