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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00630435
First received: February 28, 2008
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  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 1

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
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

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

Exclusion

  1. 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.
  2. History within 1 year of study day 1 of alcohol or drug abuse.
  3. 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 May 22, 2013