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

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NCT00472927

Last updated on May 11, 2018
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FOR MORE INFORMATION
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

NCT00472927
Pfizer
Completed
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

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Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
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
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro?, Premarin combined with medroxyprogesterone acetate (MPA).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postmenopause
Drug: Premarin/MPA 0.45 mg/1.5 mg
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2007
Not Provided

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
Sexes Eligible for Study: Female
35 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00472927
0713E1-1142
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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