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

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ClinicalTrials.gov Identifier: NCT00630435
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : February 4, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. No secondary outcome [ Time Frame: No time frame ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00630435     History of Changes
Other Study ID Numbers: 0713E1-1137
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

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