Status:
COMPLETED
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
Lead Sponsor:
Gynuity Health Projects
Conditions:
Abortion, Induced
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00386867
Start Date
October 1 2006
End Date
March 1 2007
Last Update
June 5 2007
Active Locations (8)
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1
Family Planning Associates Medical Group
Chicago, Illinois, United States
2
Planned Parenthood League of Massachusetts (Boston clinic)
Boston, Massachusetts, United States
3
Columbia University Medical Center, Division of Obstetrics & Gynecology
New York, New York, United States
4
Institute for Urban Family Health
New York, New York, United States