Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

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NCT00472927

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Study Location
Miami, Florida, 33126, United States
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Contact
1-800-718-1021
[email protected]
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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.
Show details

- Healthy, postmenopausal women, aged 35 to 70 years

- Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55

- BMI in the range of 18 to 35 kg/m2

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)


- History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor
modulators (SERMs)


- Use of prescription or investigatioanl drugs within 30 days before test article
administration

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Advanced Information
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Official Title  ICMJE An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women
Brief Summary To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro?, Premarin combined with medroxyprogesterone acetate (MPA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postmenopause
Intervention  ICMJE Drug: Premarin/MPA 0.45 mg/1.5 mg
Study Arms  ICMJE 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  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, postmenopausal women, aged 35 to 70 years
  • Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ?38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
  • BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

  • History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
  • History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
  • Use of prescription or investigatioanl drugs within 30 days before test article administration
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00472927
Other Study ID Numbers  ICMJE 0713E1-1142
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP