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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00380887
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : September 27, 2006
Sponsor:
Information provided by:

Study Description
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 Phase
Postmenopause Drug: Premarin Phase 1

Study Design

Study Type : Observational
Estimated 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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