Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen... | NCT00396799

Studies
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

NCT00396799

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Mar 13, 2007Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Menopause

Interventions

bazedoxifene/conjugated estrogens

Countries

Not provided

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

Official Title

An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women

Status Module

Record Verification Date

Mar 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

Nov 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Nov 7, 2006

First Submission Date that Met QC Criteria

Nov 7, 2006

First Posted Date

Nov 8, 2006Estimated

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

Mar 12, 2007

Last Update Posted Date

Mar 13, 2007Estimated

Description Module

Brief Summary

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
bazedoxifene/conjugated estrogens	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.

Secondary Outcomes

Measure	Description	Time Frame
Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

Women with amenorrhea starting after 54 years of age.
A history or active presence of clinically important medical diseases.
Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 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	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C447119	bazedoxifene
D004966	Estrogens, Conjugated (USP)

Ancestor Terms

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

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Browse Branches

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