MenopausePhase 1NCT00630435
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
A Phase 1 study testing Premarin®/MPA formulation A, Premarin®/MPA formulation B and Premarin®/MPA formulation C in people with Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. 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
- Menopause
- What is being tested?
- Premarin®/MPA formulation A, Premarin®/MPA formulation B and Premarin®/MPA formulation C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 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 women aged 35 to 70.
- Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes/day.
Who cannot join
- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
- History within 1 year of study day 1 of alcohol or drug abuse.
- Use of any investigational drug within 30 days before study day 1.
About this study
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
- Conditions
- Menopause
- Being tested
- Premarin®/MPA formulation A, Premarin®/MPA formulation B, Premarin®/MPA formulation C, Premarin®/MPA currently marketed product
- Keywords
- Premarin®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premarin®/MPA formulation ADrug
Premarin®/MPA formulation BDrug
Premarin®/MPA formulation CDrug
Premarin®/MPA currently marketed productDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Premarin®/MPA formulation A |
| 2 | Experimental | Not described Receives: Drug: Premarin®/MPA formulation B |
| 3 | Experimental | Not described Receives: Drug: Premarin®/MPA formulation C |
| 4 | Active comparator | Not described Receives: Drug: Premarin®/MPA currently marketed product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
Measured: 14 weeks
Secondary outcomes (1)
No secondary outcome
Measured: No time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
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
- NCT00630435
- Sponsor's protocol ID
- 0713E1-1137
- Status last verified
- Feb 2009
- First submitted
- 28 Feb 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00630435
- Acronym / sponsor ID
- 0713E1-1137
- Conditions
- Menopause
- Keywords
- Premarin®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Mar 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.
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Premarin®/MPA formulation A |
| 2 | Experimental | Drug: Premarin®/MPA formulation B |
| 3 | Experimental | Drug: Premarin®/MPA formulation C |
| 4 | Active comparator | Drug: Premarin®/MPA currently marketed product |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy postmenopausal women aged 35 to 70.
- Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
- Nonsmoker or smoker of fewer than 10 cigarettes/day.
Key exclusion criteria (3 listed)
- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
- History within 1 year of study day 1 of alcohol or drug abuse.
- Use of any investigational drug within 30 days before study day 1.
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®/MPA formulation A | Drug | 1 |
| Premarin®/MPA formulation B | Drug | 2 |
| Premarin®/MPA formulation C | Drug | 3 |
| Premarin®/MPA currently marketed product | Drug | 4 |
Primary outcome
Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
Time frame: 14 weeks
1 secondary outcome
No secondary outcome
Time frame: No time frame
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 4 Feb 2009.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Premarin®/MPA formulation A, Premarin®/MPA formulation B and Premarin®/MPA formulation C in people with Menopause, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations (time frame: 14 weeks). 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 4 Feb 2009.