NCT00484107

Brief Summary

This post-marketing study will provide local safety and tolerance data on the use of Premarin® vaginal cream.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

June 7, 2007

Last Update Submit

December 20, 2007

Conditions

Postmenopause

Interventions

Conjugated Estrogen Cream (Premarin®)DRUG

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in whom Premarin vaginal cream is indicated.
  • In the opinion of the investigator, sufficient intelligence and motivation for the patient to continue throughout the study.
  • Provide signed informed consent.

You may not qualify if:

  • Patients not willing to give informed consent.

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
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

September 1, 2005

Study Completion

October 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12