Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

This study is currently recruiting participants.

Verified by Wyeth, January 2008

First Received: October 3, 2007 Last Updated: January 11, 2008 History of Changes

Sponsors and Collaborators:	Wyeth MDS Pharma Services
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00543634

Purpose

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Condition	Intervention	Phase
Postmenopause	Drug: Premarin/MPA Drug: Provera 10 mg	Phase I

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Premarin/MPA 0.625 mg/2.5 mg X4 Drug: Premarin/MPA 0.625 mg/5 mg X 2
2: Active Comparator	Drug: Provera 10 mg 2.5 mg of MPA, 4 tablets dissoved in water

Eligibility

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

Criteria

Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea
BMI in the range of 18 to 35 kg/m2
History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
Use of any prescription or investigational drug within 30 days before test article administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543634

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Nebraska
	Recruiting
Omaha, Nebraska, United States, 68154

Sponsors and Collaborators

Wyeth

MDS Pharma Services

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0713E1-1138
Study First Received:	October 3, 2007
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00543634 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens
Estrogens, Conjugated (USP)
Medroxyprogesterone 17-Acetate
Antineoplastic Agents, Hormonal
Contraceptive Agents
Hormone Antagonists

Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Medroxyprogesterone
Healthy
Contraceptive Agents, Male
Hormones

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 July 02, 2009