The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors
This study has been terminated.
(Longer than expected recruitment period.)
Sponsor:
University of Southern California
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
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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
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 Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 16, 2013