NCT01224509

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
Last Updated

October 20, 2010

Status Verified

October 1, 2010

First QC Date

October 18, 2010

Last Update Submit

October 19, 2010

Conditions

Cervical Prostaglandin EP3 ReceptorsPregnancy

Keywords

CervixEP3 receptorsMifepristoneProstaglandinReceptorsSteroids

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • The degree of cervical dilation after the administration of mifepristone

    48 hours after the administration of mifepristone

Study Arms (2)

Mifepristone

EXPERIMENTAL
Drug: Mifepristone

Non-treatment

ACTIVE COMPARATOR
Other: Non-treatment

Interventions

MifepristoneDRUG

Administration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity

Also known as: mifeprex
Mifepristone
Non-treatmentOTHER

Non-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity

Non-treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Children's Hospital, Reproductive Research Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Marie-Soleil Wagner, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • John K Jain, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

September 1, 2004

Study Completion

March 1, 2005

Last Updated

October 20, 2010

Record last verified: 2010-10

Locations

US(1)