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

NCT ID: NCT01224509

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Prostaglandin EP3 Receptors Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

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

Non-treatment

Group Type ACTIVE_COMPARATOR

Non-treatment

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Non-treatment

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

Intervention Type OTHER

Other Intervention Names

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mifeprex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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University of Montreal

Principal Investigators

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Marie-Soleil Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

John K Jain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Women's and Children's Hospital, Reproductive Research Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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EP3 receptors

Identifier Type: -

Identifier Source: org_study_id