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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00380887
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : September 27, 2006
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Condition or disease Intervention/treatment
Postmenopause Drug: Premarin

Study Design
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Study Type : Observational
Enrollment : 54 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women
Study Start Date : June 2005

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy postmenopausal women aged 35 to 70 years
  2. Nonsmoker or smoker of less than 10 cigarettes per day

Exclusion Criteria:

  1. History or presence of clotting disorders
  2. History or presence of cancer
  3. Presence of HIV, hepatitis B or hepatitis C
  4. History of drug or alcohol abuse
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380887


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00380887     History of Changes
Other Study ID Numbers: 0713E1-133, 0713E1-135
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: September 27, 2006
Last Verified: September 2006

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
bioavailability
bioequivalence
marketed product
Premarin
 Medroxyprogesterone acetate
MPA
Postmenopausal
vasomotor symptoms

Additional relevant MeSH terms:
Medroxyprogesterone
Medroxyprogesterone Acetate
Estrogens, Conjugated (USP)
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists