NCT00167921

Brief Summary

The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
Last Updated

May 28, 2007

Status Verified

May 1, 2007

First QC Date

September 9, 2005

Last Update Submit

May 25, 2007

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (1)

  • To characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis.

Secondary Outcomes (1)

  • To estimate the systemic exposure in postmenopausal women taking a typical regimen.

Interventions

Premarin® Vaginal CreamDRUG
Premarin® oral tabletsDRUG

Eligibility Criteria

Age45 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy postmenopausal women.
  • Intact uterus.
  • Clinical diagnosis of moderate to severe atrophic vaginitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

VaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

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
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2005

Last Updated

May 28, 2007

Record last verified: 2007-05

Locations

US(2)