Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation - Full Text View

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:	NCT00630435

Purpose

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Condition	Intervention	Phase
Menopause	Drug: Premarin®/MPA formulation A Drug: Premarin®/MPA formulation B Drug: Premarin®/MPA formulation C Drug: Premarin®/MPA currently marketed product	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

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

Primary Outcome Measures:

Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

No secondary outcome [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	February 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Premarin®/MPA formulation A
Experimental: 2	Drug: Premarin®/MPA formulation B
Experimental: 3	Drug: Premarin®/MPA formulation C
Active Comparator: 4	Drug: Premarin®/MPA currently marketed product

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion

Healthy postmenopausal women aged 35 to 70.
Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
Nonsmoker or smoker of fewer than 10 cigarettes/day.

Exclusion

History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
History within 1 year of study day 1 of alcohol or drug abuse.
Use of any investigational drug within 30 days before study day 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630435

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

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00630435 History of Changes
Other Study ID Numbers:	0713E1-1137
Study First Received:	February 28, 2008
Last Updated:	February 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Premarin®

Additional relevant MeSH terms:

Estrogens, Conjugated (USP)
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012