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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014