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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Premarin®/MPA formulation A

Intervention Type DRUG

2

Group Type EXPERIMENTAL

Premarin®/MPA formulation B

Intervention Type DRUG

3

Group Type EXPERIMENTAL

Premarin®/MPA formulation C

Intervention Type DRUG

4

Group Type ACTIVE_COMPARATOR

Premarin®/MPA currently marketed product

Intervention Type DRUG

Interventions

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Premarin®/MPA formulation A

Intervention Type DRUG

Premarin®/MPA formulation B

Intervention Type DRUG

Premarin®/MPA formulation C

Intervention Type DRUG

Premarin®/MPA currently marketed product

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes