Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

This study has been completed.

First Received: May 10, 2007 Last Updated: December 4, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00472927

Purpose

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Condition	Intervention	Phase
Postmenopause	Drug: Premarin/MPA 0.45 mg/1.5 mg	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

Study Start Date:	May 2007
Study Completion Date:	August 2007

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
Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
Use of prescription or investigatioanl drugs within 30 days before test article administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472927

Locations

United States, Florida

Miami, Florida, United States, 33126

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	0713E1-1142
Study First Received:	May 10, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00472927 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Pharmacologic Actions
Estrogens, Conjugated (USP)
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010