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

This study has been completed.

First Received on October 3, 2007. Last Updated on June 17, 2010 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:	MDS Pharma Services
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Health Services Research
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 is now a wholly owned subsidiary of Pfizer:

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
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Premarin/MPA 0.625 mg/2.5 mg X4 Drug: Premarin/MPA 0.625 mg/5 mg X 2
Active Comparator: 2	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

Locations

United States, Nebraska

Omaha, Nebraska, United States, 68154

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

MDS Pharma Services

Investigators

Study Director:

Pfizer CT.gov Call Center

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier:	NCT00543634 History of Changes
Other Study ID Numbers:	0713E1-1138
Study First Received:	October 3, 2007
Last Updated:	June 17, 2010
Health Authority:	United States: Food and Drug Administration

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 12, 2012