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:

Drug Information available for: Medroxyprogesterone acetate Estrogens, conjugated

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 28, 2016

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