Status:
COMPLETED
Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)
Lead Sponsor:
Gynuity Health Projects
Conditions:
Abortion, Induced
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is...
Eligibility Criteria
Inclusion
- Gestational age less than or equal to 63 days
- General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
- Willing to provide an address and/or telephone number for purposes of follow-up.
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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00870272
Start Date
July 1 2007
End Date
March 1 2009
Last Update
March 27 2009
Active Locations (1)
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1
State University of Medicine and Pharmacy
Chisinau, Moldova