Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis

A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00167921

Enrollment

Registered

2005-09-14

Start date

2005-10-31

Completion date

Unknown

Last updated

2007-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophic Vaginitis

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.

Interventions

DRUGPremarin® Vaginal Cream

DRUGPremarin® oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To estimate the systemic exposure in postmenopausal women taking a typical regimen.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026