Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis; Postmenopause
Intervention: Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg (Drug)
Phase: Phase 1
Sponsored by: Wyeth
Official(s) and/or principal investigator(s):
Trial Manager, Study Director, Affiliation: Wyeth
This study will compare the bioequivalence of two new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and medroxyprogesterone, 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 and MPA provide
the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
Official title: An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.
Study design: Prevention, Non-Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence 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, tÂ½, AUC0-T, AUC0-Â¥.
Minimum age: 35 Years.
Maximum age: 70 Years.
- 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 5 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
Starting date: September 2006
Ending date: January 2007
Last updated: June 8, 2007