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Completed

NCT Number: NCT00630435

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

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.

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Key information

Conditions

Menopause

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion

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

Exclusion

  • 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.
  • History within 1 year of study day 1 of alcohol or drug abuse.
  • Use of any investigational drug within 30 days before study day 1.

Treatment and study plan

Premarin®/MPA formulation A

Drug

Premarin®/MPA formulation B

Drug

Premarin®/MPA formulation C

Drug

Premarin®/MPA currently marketed product

Drug

Primary outcomes

  1. Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations

    Time frame: 14 weeks

Secondary outcomes

  1. No secondary outcome

    Time frame: No time frame

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2008
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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