Mifepristone at Same Time Multicenter Study

Phase 4

Completed

• Conditions: Abortion Seekers

• Registration Number: NCT00269568
• Lead Sponsor: University of Pittsburgh

Brief Summary

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%

Detailed Description

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%.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-23
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1128

Inclusion Criteria

pregnancy equal to or less than 63 days at enrollment -

Exclusion Criteria

abnormal pregnancy diagnosed by ultrasound

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
complete abortion rate	5 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
to compare complete abortion rates by gestational age	5 weeks after treatment
compare bleeding and side effect profiles	up to 5 weeks after treatment
compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control	up to 24 hours after treatment
compare acceptability of the two regimens	2 weeks after treatment
describe the prevalence of domestic violence in a medical abortion research population	at time of enrollment
measure time to first ovulation	up to 10 weeks after treatment
compare elapsed time to ovulation between treatment regimens	up to 10 weeks after treatment
evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start	up to 12 weeks after treatment

Trial Locations

Locations (4)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States