PostmenopausePhase 1NCT00706225
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
A Phase 1 study testing Bazedoxifene and conjugated estrogens in people with Postmenopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- Bazedoxifene and conjugated estrogens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2008
- Phase
- Phase 1
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
- Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
- Must not have a history of drug or alcohol abuse within 1 year and do not consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine)
- Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
- Must not donate any other plasma or blood during the total study.
- All test results and study criteria for the study are met.
Who cannot join
- Only healthy postmenopausal women are eligible.
- Health assessed by clinical chemistry laboratory results and physical exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single/Multiple Dose, Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Bazedoxifene On Conjugated Estrogens (CE) In Healthy Postmenopausal Women
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis.
PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.
Read more
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.
Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.
- Conditions
- Postmenopause
- Being tested
- Bazedoxifene and conjugated estrogens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bazedoxifene and conjugated estrogensDrug
Bazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bazedoxifene and Conjugated Estrogens (BZA \& CE) Receives: Drug: Bazedoxifene and conjugated estrogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.
Measured: 3 months
Secondary outcomes (1)
To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00706225
- Sponsor's protocol ID
- 3115A1-1134
- Status last verified
- Sep 2010
- First submitted
- 25 Jun 2008
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single/Multiple Dose, Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Bazedoxifene On Conjugated Estrogens (CE) In Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00706225
- Acronym / sponsor ID
- 3115A1-1134
- Conditions
- Postmenopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jun 2008 (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.
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis.
PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms of menopause (i.e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis.
The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women.
Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bazedoxifene and conjugated estrogensBazedoxifene and Conjugated Estrogens (BZA \& CE) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive
- Have not participated in a clinical drug study for at least 30 days prior to study medication administration,
- Must not have a history of drug or alcohol abuse within 1 year and do not consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine)
- Must either be a non-smoker or smoke less than 10 cigarettes per day, and must be able to abstain from smoking during clinic confinements,
- Must not donate any other plasma or blood during the total study.
Key exclusion criteria (2 listed)
- Only healthy postmenopausal women are eligible.
- Health assessed by clinical chemistry laboratory results and physical exam.
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 and conjugated estrogensBazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart. | Drug | 1 |
Primary outcome
To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.
Time frame: 3 months
1 secondary outcome
To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
Time frame: 3 months
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 23 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bazedoxifene and conjugated estrogens in people with Postmenopause, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site 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 6 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: finished, as of the sponsor's last update on 23 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 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women. (time frame: 3 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 23 Sep 2010.