The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors (EP3)

October 19, 2010 updated by: University of Southern California

Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Women's and Children's Hospital, Reproductive Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone
Drug: Mifepristone
Administration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity
Other Names:
  • mifeprex
Active Comparator: Non-treatment
Other: Non-treatment
Non-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Marie-Soleil Wagner, MD, University of Southern California
  • Principal Investigator: John K Jain, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 20, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP3 receptors

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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