Mifepristone at Same Time Multicenter Study
Completed · Phase 4
Conditions studied: Abortion Seekers
In brief
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%
Key facts
- Study ID
- NCT00269568
- Run by
- University of Pittsburgh
- People needed
- 1128
- Starts
- 2004-06-01
- Expected to finish
- 2006-04-01
- Last updated by the study team
- 2016-01-29
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.
Where it is running
- University of Southern California — Los Angeles, California, United States
- Northwestern University — Chicago, Illinois, United States
- Oregon Health Sciences University — Portland, Oregon, United States
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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