Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

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

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Detailed Description

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Conditions

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Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Premarin/MPA 0.45 mg/1.5 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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0713E1-1142

Identifier Type: -

Identifier Source: org_study_id