Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioavailability Study Among 3 New Formulations of Premarin 0.625 mg/Medroxyprogesterone Acetate (Mpa) 2.5 mg Compared With a Reference Formulation of Premarin/Mpa (Prempro) 0.625 mg/2.5 mg in Healthy Postmenopausal Women

This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.

Study Overview

• Status: Completed
• Conditions: Estrogen Replacement Therapy
• Intervention / Treatment: Drug: conjugated estrogens/progestin (MPA)

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy, postmenopausal women ages 35 to 70 years, inclusive.
• Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): December 6, 2007
• Last Update Submitted That Met QC Criteria: December 4, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: 0713E1-136