Cervical Prostaglandin EP3 ReceptorsEP3NCT01224509
The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors
A study testing Mifepristone and Non-treatment in people with Cervical Prostaglandin EP3 Receptors and Pregnancy, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Prostaglandin EP3 Receptors, Pregnancy
- What is being tested?
- Mifepristone and Non-treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's and Children's Hospital, Reproductive Research Center
Los Angeles, California, 90033
About this study
Official title: Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone
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.
- Conditions
- Cervical Prostaglandin EP3 Receptors, Pregnancy
- Being tested
- Mifepristone, Non-treatment
- Keywords
- Cervix, EP3 receptors, Mifepristone, Prostaglandin, Receptors, Steroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called mifeprex
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-treatmentOther
Non-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Not described Receives: Drug: Mifepristone |
| Non-treatment | Active comparator | Not described Receives: Other: Non-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of expression of EP3 receptor mRNA levels in cervical tissue after the administration of mifepristone
Measured: 48 hours after the administration of mifepristone
Secondary outcomes (1)
The degree of cervical dilation after the administration of mifepristone
Measured: 48 hours after the administration of mifepristone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2004
- Study completionMar 2005
Why it stopped: Longer than expected recruitment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Prostaglandin EP3 ReceptorsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Investigators
- Marie-Soleil Wagner, MD, Principal investigator, University of Southern CaliforniaJohn K Jain, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224509
- Sponsor's protocol ID
- EP3 receptors
- Acronym
- EP3
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone
- ClinicalTrials.gov ID
- NCT01224509
- Acronym / sponsor ID
- EP3 / EP3 receptors
- Conditions
- Cervical Prostaglandin EP3 Receptors, Pregnancy
- Keywords
- Cervix, EP3 receptors, Mifepristone, Prostaglandin, Receptors, Steroids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Longer than expected recruitment period.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: Mifepristone |
| Non-treatment | Active comparator | Other: Non-treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAlso: mifeprexAdministration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity | Drug | Mifepristone |
| Non-treatmentNon-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity | Other | Non-treatment |
Primary outcome
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
1 secondary outcome
The degree of cervical dilation after the administration of mifepristone
Time frame: 48 hours after the administration of mifepristone
Results and safety
The study was stopped early (reason given: Longer than expected recruitment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Soleil Wagner, MD principal investigator
University of Southern California
John K Jain, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone and Non-treatment in people with Cervical Prostaglandin EP3 Receptors and Pregnancy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Longer than expected recruitment period.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.