NCT00380887

Brief Summary

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

September 27, 2006

Status Verified

September 1, 2006

First QC Date

September 26, 2006

Last Update Submit

September 26, 2006

Conditions

Postmenopause

Keywords

bioavailabilitybioequivalencemarketed productPremarinMedroxyprogesterone acetateMPAPostmenopausalvasomotor symptoms

Interventions

PremarinDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy postmenopausal women aged 35 to 70 years
  • Nonsmoker or smoker of less than 10 cigarettes per day

You may not qualify if:

  • History or presence of clotting disorders
  • History or presence of cancer
  • Presence of HIV, hepatitis B or hepatitis C
  • History of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Estrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Study Start

June 1, 2005

Last Updated

September 27, 2006

Record last verified: 2006-09