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

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

Sponsors

Lead Sponsor: University of Southern California

Source University of Southern California
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.

Overall Status Terminated
Start Date 2004-09-01
Completion Date 2005-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
The degree of cervical dilation after the administration of mifepristone 48 hours after the administration of mifepristone
Enrollment 18
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mifepristone

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

Arm Group Label: Mifepristone

Other Name: mifeprex

Intervention Type: Other

Intervention Name: Non-treatment

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

Arm Group Label: Non-treatment

Eligibility

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Women's and Children's Hospital, Reproductive Research Center
Location Countries

United States

Verification Date

2010-10-01

Responsible Party

Name Title: Marie-Soleil Wagner, MD

Organization: University of Montreal

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Mifepristone

Type: Experimental

Label: Non-treatment

Type: Active Comparator

Acronym EP3
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov

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