Official Title: “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).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment

Intervention(s) in this Clinical Trial

• Drug: Premarin/MPA 0.45 mg/1.5 mg

Primary Measures

• Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00472927

Study ID Number: 0713E1-1142

ClinicalTrials.gov Identifier: NCT00472927

Health Authority: United States: Institutional Review Board