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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00380887
First received: September 26, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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 Intervention Phase
Postmenopause
 Drug: Premarin
 Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 54
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00380887     History of Changes
Other Study ID Numbers: 0713E1-133, 0713E1-135
Study First Received: September 26, 2006
Last Updated: September 26, 2006
Health Authority: United States: Institutional Review Board

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:
Estrogens, Conjugated (USP)
Medroxyprogesterone
Medroxyprogesterone Acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013