PostmenopauseNCT00380887
Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
An observational study of Postmenopause, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro. 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?
- Premarin
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to not given
- 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 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 years
- Nonsmoker or smoker of less than 10 cigarettes per day
Who cannot join
- History or presence of clotting disorders
- History or presence of cancer
- Presence of HIV, hepatitis B or hepatitis C
- History of drug or alcohol abuse
About this study
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women
The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
- Conditions
- Postmenopause
- Being tested
- Premarin
- Keywords
- bioavailability, bioequivalence, marketed product, Premarin, Medroxyprogesterone acetate, MPA, Postmenopausal, vasomotor symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PremarinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startJun 2005
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
- Defined population
- Time perspective
- Other
- Enrolment
- 54 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
- NCT00380887
- Sponsor's protocol ID
- 0713E1-133, 0713E1-135
- Status last verified
- Sep 2006
- First submitted
- 26 Sep 2006
- Last updated
- 27 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00380887
- Acronym / sponsor ID
- 0713E1-133, 0713E1-135
- Conditions
- Postmenopause
- Keywords
- bioavailability, bioequivalence, marketed product, Premarin, Medroxyprogesterone acetate, MPA, Postmenopausal, vasomotor symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 27 Sep 2006 (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 bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy postmenopausal women aged 35 to 70 years
- Nonsmoker or smoker of less than 10 cigarettes per day
Key exclusion criteria (4 listed)
- History or presence of clotting disorders
- History or presence of cancer
- Presence of HIV, hepatitis B or hepatitis C
- History of drug or alcohol abuse
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Sep 2006.
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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?
An observational study of Postmenopause, 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 2 inclusion and 4 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 27 Sep 2006. 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.
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.
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 27 Sep 2006.