Menopause
Conditions
Keywords
Premarin®
Brief summary
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
Interventions
DRUGPremarin®/MPA formulation A
DRUGPremarin®/MPA formulation B
DRUGPremarin®/MPA formulation C
DRUGPremarin®/MPA currently marketed product
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion 1. Healthy postmenopausal women aged 35 to 70. 2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. 3. Nonsmoker or smoker of fewer than 10 cigarettes/day. Exclusion 1. History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control. 2. History within 1 year of study day 1 of alcohol or drug abuse. 3. Use of any investigational drug within 30 days before study day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations | 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome | No time frame |
Outcome results
None listed