The Effect of Mifepristone on the Expression of Cervical... | NCT01224509

Studies
The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors

NCT01224509

Sponsor

University of Southern California

Status

Terminated

Last Update Posted

Oct 20, 2010Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Cervical Prostaglandin EP3 Receptors
Pregnancy

Interventions

Mifepristone
Non-treatment

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

Oct 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Longer than expected recruitment period.

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Mar 2005Actual

First Submitted Date

Oct 18, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

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

Oct 19, 2010

Last Update Posted Date

Oct 20, 2010Estimated

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 this study is to determine the effect of mifepristone on the expression of three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days gestational age.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mifepristone	Experimental		Drug: Mifepristone
Non-treatment	Active Comparator		Other: Non-treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mifepristone	Drug	Administration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity	Mifepristone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The amount of expression of EP3 receptor mRNA levels in cervical tissue after the administration of mifepristone		48 hours after the administration of mifepristone

Secondary Outcomes

Measure	Description	Time Frame
The degree of cervical dilation after the administration of mifepristone		48 hours after the administration of mifepristone

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good general health
≥18 years old
seeking termination of a viable intrauterine pregnancy of ≤63 days, without any evidence of a threatened or spontaneous abortion

Exclusion Criteria:

medical problems
confirmed or suspected ectopic pregnancy
having taken medications in the seven days prior to enrollment that would affect PG synthesis or metabolism of mifepristone

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Soleil Wagner, MD	University of Southern California	Principal Investigator
John K Jain, MD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's and Children's Hospital, Reproductive Research Center		Los Angeles	California	90033	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015735	Mifepristone

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided