Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

Wyeth

Status and phase: Completed; Phase 1

Conditions: Menopause

Treatments: Drug: Premarin®/MPA currently marketed product; Drug: Premarin®/MPA formulation B; Drug: Premarin®/MPA formulation C; Drug: Premarin®/MPA formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630435

0713E1-1137

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

76 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: Premarin®/MPA formulation A

2

Experimental group

Treatment:

Drug: Premarin®/MPA formulation B

3

Experimental group

Treatment:

Drug: Premarin®/MPA formulation C

4

Active Comparator group

Treatment:

Drug: Premarin®/MPA currently marketed product