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

This study has been terminated.
(Longer than expected recruitment period.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224509
First Posted: October 20, 2010
Last Update Posted: October 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Southern California
  Purpose
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.

Condition Intervention
Cervical Prostaglandin EP3 Receptors Pregnancy Drug: Mifepristone Other: Non-treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • The degree of cervical dilation after the administration of mifepristone [ Time Frame: 48 hours after the administration of mifepristone ]

Enrollment: 18
Study Start Date: September 2004
Study Completion Date: March 2005
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224509


Locations
United States, California
Women's and Children's Hospital, Reproductive Research Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
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
  More Information

Responsible Party: Marie-Soleil Wagner, MD, University of Montreal
ClinicalTrials.gov Identifier: NCT01224509     History of Changes
Other Study ID Numbers: EP3 receptors
First Submitted: October 18, 2010
First Posted: October 20, 2010
Last Update Posted: October 20, 2010
Last Verified: October 2010

Keywords provided by University of Southern California:
Cervix
EP3 receptors
Mifepristone
Prostaglandin
Receptors
Steroids

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents