Primary Ovarian InsufficiencyPhase 1NCT01436513
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
A Phase 1 study testing Premarin reference tablet (fasted), Premarin new tablet (fasted) and Premarin reference tablet (fed) in people with Primary Ovarian Insufficiency and Vaginitis, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia
- What is being tested?
- Premarin reference tablet (fasted), Premarin new tablet (fasted) and Premarin reference tablet (fed)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2011to Mar 2012
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese healthy postmenopausal women
Who cannot join
- History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
- History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
- History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Being tested
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed), Premarin new tablet (fed)
- Keywords
- bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated
- Medical subject headings
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premarin reference tablet (fasted)Drug
Premarin reference tablet, single dose, fasted conditions
Premarin new tablet (fasted)Drug
Premarin new tablet, single dose, fasted conditions
Premarin reference tablet (fed)Drug
Premarin reference tablet, single dose, fed conditions
Premarin new tablet (fed)Drug
Premarin new tablet, single dose, fed conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Premarin reference tablet as a single oral dose under fasted conditions Receives: Drug: Premarin reference tablet (fasted) |
| B | Experimental | Premarin new tablet as a single oral dose under fasted conditions Receives: Drug: Premarin new tablet (fasted) |
| C | Experimental | Premarin reference tablet as a single oral dose under fed conditions Receives: Drug: Premarin reference tablet (fed) |
| D | Experimental | Premarin new tablet as a single oral dose under fed conditions Receives: Drug: Premarin new tablet (fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Measured: Day 1 to Day 4
Secondary outcomes (16)
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Tmax
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUClast
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCinf
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:MRT
Measured: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:half-life
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall
Measured: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436513
- Sponsor's protocol ID
- B2811002
- Other IDs
- 3117X3-1112
- Status last verified
- Mar 2012
- First submitted
- 16 Sep 2011
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01436513
- Acronym / sponsor ID
- B2811002
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Keywords
- bioequivalence, menometrorrhagia, climacteric disturbance, Estrogen Replacement Therapy, Estrogens Conjugated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Sep 2011 (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 assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Premarin reference tablet (fasted)Premarin reference tablet as a single oral dose under fasted conditions |
| B | Experimental | Drug: Premarin new tablet (fasted)Premarin new tablet as a single oral dose under fasted conditions |
| C | Experimental | Drug: Premarin reference tablet (fed)Premarin reference tablet as a single oral dose under fed conditions |
| D | Experimental | Drug: Premarin new tablet (fed)Premarin new tablet as a single oral dose under fed conditions |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Japanese healthy postmenopausal women
Key exclusion criteria (3 listed)
- History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
- History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
- History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.
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 |
|---|---|---|
| Premarin reference tablet (fasted)Premarin reference tablet, single dose, fasted conditions | Drug | A |
| Premarin new tablet (fasted)Premarin new tablet, single dose, fasted conditions | Drug | B |
| Premarin reference tablet (fed)Premarin reference tablet, single dose, fed conditions | Drug | C |
| Premarin new tablet (fed)Premarin new tablet, single dose, fed conditions | Drug | D |
Primary outcome
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Time frame: Day 1 to Day 4
16 secondary outcomes
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Tmax
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUClast
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCinf
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:MRT
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:half-life
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:half-life
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Cmax
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:Tmax
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUClast
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:AUCall
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline unadjusted) pharmacokinetic parameter:MRT
Time frame: Day 1 to Day 4
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 15 Mar 2012.
- 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 Premarin reference tablet (fasted), Premarin new tablet (fasted) and Premarin reference tablet (fed) in people with Primary Ovarian Insufficiency and Vaginitis, run by Pfizer at 1 site in Japan.
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 1 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 15 Mar 2012. 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 Japan. 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?
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax (time frame: Day 1 to Day 4). The study lists 4 primary outcomes in all. 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 15 Mar 2012.