Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

This study has been completed.

First Received on September 26, 2006. No Changes Posted

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00380887

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 I

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:

Drug Information available for: Estrogens, conjugated Medroxyprogesterone 17-acetate Medroxyprogesterone

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:

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

Exclusion Criteria:

History or presence of clotting disorders
History or presence of cancer
Presence of HIV, hepatitis B or hepatitis C
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 Acetate
Medroxyprogesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Male

Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 09, 2012