Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381251
Status:
COMPLETED
Last Update Posted:
2007-06-11
First Post:
2006-09-26
Brief Title:
Study Comparing Bioequivalence of Two New Formulations of PremarinMPA With PremarinMPA Reference Formulation
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
An Open-Label Single-Dose Randomized 3-Period Crossover Bioequivalence Study Between Two New Formulations of 045 mg15 mg Premarin Medroxyprogesterone Acetate MPA Compared With a Reference Formulation of 045mg15mg Premarin MPA Prempro in Healthy Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None