- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386867
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
June 1, 2007 updated by: Gynuity Health Projects
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States
- Family Planning Associates Medical Group
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Massachusetts
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Boston, Massachusetts, United States
- Planned Parenthood League of Massachusetts (Boston clinic)
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New York
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New York, New York, United States
- Columbia University Medical Center, Division of Obstetrics & Gynecology
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New York, New York, United States
- Institute for Urban Family Health
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New York, New York, United States
- Parkmed
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
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Texas
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Austin, Texas, United States
- Whole Women's Health
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Waco, Texas, United States
- Planned Parenthood
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- be willing and able to sign consent forms;
- be eligible for medical abortion according to clinician's assessment;
- be willing to undergo a surgical completion if necessary;
- have ready and easy access to a telephone and emergency transportation;
- speak English, Spanish, or have a translator available to translate for all study procedures; and,
- agree to comply with the study procedures and visit schedule.
Exclusion Criteria:
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- IUD in place;
- Chronic renal failure;
- Concurrent long-term corticosteroid therapy;
- History of allergy to mifepristone, misoprostol or other prostaglandin;
- Hemorrhagic disorders or concurrent anticoagulant therapy;
- Inherited porphyrias; or
- Other serious physical or mental health conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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efficacy
|
Secondary Outcome Measures
Outcome Measure |
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acceptability
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Completion
March 1, 2007
Study Registration Dates
First Submitted
October 10, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (ESTIMATE)
October 12, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
June 5, 2007
Last Update Submitted That Met QC Criteria
June 1, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.1.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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