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

This study has been terminated.
(Longer than expected recruitment period.)
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01224509
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: October 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The degree of cervical dilation after the administration of mifepristone [ Time Frame: 48 hours after the administration of mifepristone ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marie-Soleil Wagner, MD, University of Montreal
ClinicalTrials.gov Identifier: NCT01224509     History of Changes
Other Study ID Numbers: EP3 receptors
Study First Received: October 18, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014