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

Pregnancy Clinical Trial

— EP3  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01224509
• Other study ID #: EP3 receptors
• Status: Terminated
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 19, 2010
• Start date: September 2004
• Est. completion date: March 2005

Study information

• Verified date: October 2010
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cervical Prostaglandin EP3 Receptors
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Women's and Children's Hospital, Reproductive Research Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of expression of EP3 receptor mRNA levels in cervical tissue after the administration of mifepristone		48 hours after the administration of mifepristone	No
Secondary	The degree of cervical dilation after the administration of mifepristone		48 hours after the administration of mifepristone	No