Study Comparing Premarin® Vaginal Cream Versus Premarin®... | NCT00167921

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

NCT00167921

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

May 28, 2007Estimated

Enrollment

Phase

Phase 1

Conditions

Atrophic Vaginitis

Interventions

Premarin® Vaginal Cream
Premarin® oral tablets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2007

Last Update Posted Date

May 28, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
To estimate the systemic exposure in postmenopausal women taking a typical regimen.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D059268	Atrophic Vaginitis

Ancestor Terms

ID	Term
D014627	Vaginitis
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004966	Estrogens, Conjugated (USP)

Ancestor Terms

ID	Term
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided