|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 26, 2006 | ||||
| Last Updated Date | June 8, 2007 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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-¥. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00381251 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. | ||||
| Official Title ICMJE | 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. | ||||
| 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. |
||||
| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Drug: Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | January 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 35 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00381251 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0713E1-134 | ||||
| Study Sponsor ICMJE | Wyeth | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Wyeth | ||||
| Verification Date | June 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||