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Trial record 1 of 1 for:    NCT00380887
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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00380887
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : September 27, 2006
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date September 26, 2006
First Posted Date September 27, 2006
Last Update Posted Date September 27, 2006
Study Start Date June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: September¬†26,¬†2006)
54
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not 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
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2006