drugset / Trial / NCT00401219
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2006-11
- Primary completion
- —
- Completion
- 2007-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | conjugated estrogens | Other / unclassified | 0.625 mg | — |
| Subject | medroxyprogesterone acetate | Other / unclassified | 2.5 mg | — |
Indications
No indication recorded.