Study Comparing Premarin®/MPA, PREMPRO® and Provera® in H... | NCT00543634

Studies
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

NCT00543634

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Jun 22, 2010Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Postmenopause

Interventions

Premarin/MPA
Premarin/MPA
Provera 10 mg

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

Official Title

Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Oct 3, 2007

First Submission Date that Met QC Criteria

Oct 11, 2007

First Posted Date

Oct 15, 2007Estimated

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

Jun 17, 2010

Last Update Posted Date

Jun 22, 2010Estimated

Name	Class
MDS Pharma Services	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Premarin/MPA
2	Active Comparator		Drug: Provera 10 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Premarin/MPA	Drug	0.625 mg/2.5 mg X4	1
Premarin/MPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).		4 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea
BMI in the range of 18 to 35 kg/m2
History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
Use of any prescription or investigational drug within 30 days before test article administration

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
Pfizer CT.gov Call Center	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Omaha	Nebraska	68154	United States

Intervention Browse Module

MeSH Terms

ID	Term
D017258	Medroxyprogesterone Acetate

Ancestor Terms

ID	Term
D008525	Medroxyprogesterone
D006908	Hydroxyprogesterones
D011374	Progesterone
D011282	Pregnenediones

Browse Leaves

Not provided

Browse Branches

Not provided