Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Estrogen Replacement Therapy
Intervention: conjugated estrogens/progestin (MPA) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Primary outcome: 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-¥.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: November 2006
Ending date: February 2007
Last updated: December 4, 2007
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