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NCT01224509 Clinical Trial

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
Secondary ID
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
Est. primary completion date
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
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