Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
NCT00380887
Last updated date
ABOUT THIS STUDY
The purpose of this study is to determine bioequivalence and bioavailability of four
different Premarin/MPA test formulations versus the current formulation for Prempro.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
35-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
1. Healthy postmenopausal women aged 35 to 70 years
2. Nonsmoker or smoker of less than 10 cigarettes per day
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
1. History or presence of clotting disorders
2. History or presence of cancer
3. Presence of HIV, hepatitis B or hepatitis C
4. History of drug or alcohol abuse
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women | |||
| 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Not Provided | |||
| Condition | Postmenopause | |||
| Intervention | Drug: Premarin | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Enrollment | 54 | |||
| Original Enrollment | Same as current | |||
| Study Completion Date | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 35 Years to 70 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00380887 | |||
| Other Study ID Numbers | 0713E1-133, 0713E1-135 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | September 2006 | |||