Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00543634
First received: October 3, 2007
Last updated: June 17, 2010
Last verified: June 2010

October 3, 2007
June 17, 2010
October 2007
December 2007   (final data collection date for primary outcome measure)
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
Complete list of historical versions of study NCT00543634 on ClinicalTrials.gov Archive Site
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Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Postmenopause
  • Drug: Premarin/MPA
    0.625 mg/2.5 mg X4
  • Drug: Premarin/MPA
    0.625 mg/5 mg X 2
  • Drug: Provera 10 mg
    2.5 mg of MPA, 4 tablets dissoved in water
  • Active Comparator: 1
    Interventions:
    • Drug: Premarin/MPA
    • Drug: Premarin/MPA
  • Active Comparator: 2
    Intervention: Drug: Provera 10 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2007
December 2007   (final data collection date for primary outcome measure)
  • Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea
  • BMI in the range of 18 to 35 kg/m2
  • History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
  • History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
  • Use of any prescription or investigational drug within 30 days before test article administration
Female
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00543634
0713E1-1138
No
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
MDS Pharma Services
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2010

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