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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

Last updated on October 11, 2019

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Study Location
Contact
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
35-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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

NCT00380887
Pfizer
Completed
Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

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Descriptive Information
Brief TitleStudy Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
Official TitleAn 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 SummaryThe purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionPostmenopause
InterventionDrug: Premarin
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: September 26, 2006)
54
Original EnrollmentSame as current
Study Completion DateNot Provided
Primary Completion DateNot Provided
Eligibility Criteria

Inclusion Criteria:

  1. Healthy postmenopausal women aged 35 to 70 years
  2. Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion Criteria:

  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
Sex/Gender
Sexes Eligible for Study:Female
Ages35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00380887
Other Study ID Numbers0713E1-133, 0713E1-135
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateSeptember 2006

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

BY EMAIL

Contact

[email protected]

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