PostmenopauseNCT00847821
Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene
An observational study of Postmenopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 22 sites in United States.
Trial summary
This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- Bazedoxifene 10 mg/CE 0.625 mg, Bazedoxifene 20 mg/CE 0.625 mg and Bazedoxifene 40 mg/CE 0.625 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 22 sitesUnited States
- Study dates
- May 2009to Aug 2010
- Phase
- Observational
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women who participated in and completed the 3115A1-303 study, were at least 80% compliant with test article administration during the study, and have provided a new signed and written informed consent for study 3115A1-1125.
Who may be able to join
- Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
- Has completed 24 months of treatment.
- Was at least 80% compliant with study drug administration.
Who cannot join
- Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
- Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Pfizer Investigational Site
Billings, Montana, 59102
Pfizer Investigational Site
Charlottesville, Virginia, 22903
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45267
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Fort Myers, Florida, 33916
Pfizer Investigational Site
Gainesville, Florida, 32606
Pfizer Investigational Site
Greenville, South Carolina, 29605
Pfizer Investigational Site
Las Vegas, New Mexico, 89416
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Louisville, Kentucky, 40291
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
Wexford, Pennsylvania, 15090
About this study
Official title: RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.
Read the detailed description
The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible in case of a regulatory inspection of the 303 protocol. Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP) approval, and enrollment could not be met without the inclusion of these subjects. The study was not terminated due to safety concerns.
- Conditions
- Postmenopause
- Being tested
- Bazedoxifene 10 mg/CE 0.625 mg, Bazedoxifene 20 mg/CE 0.625 mg, Bazedoxifene 40 mg/CE 0.625 mg, Bazedoxifene 10 mg/CE 0.45 mg, Bazedoxifene 20 mg/CE 0.45 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene 10 mg/CE 0.625 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Bazedoxifene 20 mg/CE 0.625 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Bazedoxifene 40 mg/CE 0.625 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Bazedoxifene 10 mg/CE 0.45 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Bazedoxifene 20 mg/CE 0.45 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Bazedoxifene 40 mg/CE 0.45 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
Raloxifene 60 mgDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as raloxifene tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
PlaceboDrug
No dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as placebo capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study.
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene 10 mg/CE 0.625 mg | Not described Receives: Drug: Bazedoxifene 10 mg/CE 0.625 mg | |
| Bazedoxifene 20 mg/CE 0.625 mg | Not described Receives: Drug: Bazedoxifene 20 mg/CE 0.625 mg | |
| Bazedoxifene 40 mg/CE 0.625 mg | Not described Receives: Drug: Bazedoxifene 40 mg/CE 0.625 mg | |
| Bazedoxifene 10 mg/CE 0.45 mg | Not described Receives: Drug: Bazedoxifene 10 mg/CE 0.45 mg | |
| Bazedoxifene 20 mg/CE 0.45 mg | Not described Receives: Drug: Bazedoxifene 20 mg/CE 0.45 mg | |
| Bazedoxifene 40 mg/CE 0.45 mg | Not described Receives: Drug: Bazedoxifene 40 mg/CE 0.45 mg | |
| Raloxifene 60 mg | Not described Receives: Drug: Raloxifene 60 mg | |
| Placebo | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
Measured: Baseline, 6 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847821
- Sponsor's protocol ID
- 3115A1-1125
- Other IDs
- B2311003
- Status last verified
- Sep 2010
- First submitted
- 18 Feb 2009
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
- ClinicalTrials.gov ID
- NCT00847821
- Acronym / sponsor ID
- 3115A1-1125
- Conditions
- Postmenopause
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 Feb 2009 (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.
This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.
Detailed description
The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible in case of a regulatory inspection of the 303 protocol. Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP) approval, and enrollment could not be met without the inclusion of these subjects. The study was not terminated due to safety concerns.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene 10 mg/CE 0.625 mg | – | Drug: Bazedoxifene 10 mg/CE 0.625 mg |
| Bazedoxifene 20 mg/CE 0.625 mg | – | Drug: Bazedoxifene 20 mg/CE 0.625 mg |
| Bazedoxifene 40 mg/CE 0.625 mg | – | Drug: Bazedoxifene 40 mg/CE 0.625 mg |
| Bazedoxifene 10 mg/CE 0.45 mg | – | Drug: Bazedoxifene 10 mg/CE 0.45 mg |
| Bazedoxifene 20 mg/CE 0.45 mg | – | Drug: Bazedoxifene 20 mg/CE 0.45 mg |
| Bazedoxifene 40 mg/CE 0.45 mg | – | Drug: Bazedoxifene 40 mg/CE 0.45 mg |
| Raloxifene 60 mg | – | Drug: Raloxifene 60 mg |
| Placebo | – | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women who participated in and completed the 3115A1-303 study, were at least 80% compliant with test article administration during the study, and have provided a new signed and written informed consent for study 3115A1-1125.
Key inclusion criteria (3 listed)
- Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
- Has completed 24 months of treatment.
- Was at least 80% compliant with study drug administration.
Key exclusion criteria (2 listed)
- Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
- Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)
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 10 mg/CE 0.625 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 10 mg/CE 0.625 mg |
| Bazedoxifene 20 mg/CE 0.625 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 20 mg/CE 0.625 mg |
| Bazedoxifene 40 mg/CE 0.625 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 40 mg/CE 0.625 mg |
| Bazedoxifene 10 mg/CE 0.45 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 10 mg/CE 0.45 mg |
| Bazedoxifene 20 mg/CE 0.45 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 20 mg/CE 0.45 mg |
| Bazedoxifene 40 mg/CE 0.45 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as bazedoxifene/CE tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Bazedoxifene 40 mg/CE 0.45 mg |
| Raloxifene 60 mgNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as raloxifene tablets in capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Raloxifene 60 mg |
| PlaceboNo dose taken during this study; however, this intervention was taken while study 3115A1-303 was ongoing. In the 3115A1-303 study, test article was supplied as placebo capsules. The dosage was one capsule orally, once daily, at approximately the same time each day on a continuous regiment for 2 years, or until early discontinuation from the study. | Drug | Placebo |
Primary outcome
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
Time frame: Baseline, 6 months and 24 months
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 22 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 2 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: stopped early, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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?
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups (time frame: Baseline, 6 months and 24 months). 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 6 Sep 2010.