Mifepristone at Same Time Multicenter Study (MAST)

This study has been completed.

Sponsor:

Collaborator:

Anonymous

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00269568

First received: September 12, 2005

Last updated: October 20, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 20, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

complete abortion rate [ Time Frame: 5 weeks after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

complete abortion rate

Change History

Complete list of historical versions of study NCT00269568 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

to compare complete abortion rates by gestational age [ Time Frame: 5 weeks after treatment ] [ Designated as safety issue: No ]
compare bleeding and side effect profiles [ Time Frame: up to 5 weeks after treatment ] [ Designated as safety issue: Yes ]
compare acceptability of the two regimens [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control [ Time Frame: up to 24 hours after treatment ] [ Designated as safety issue: No ]
measure time to first ovulation [ Time Frame: up to 10 weeks after treatment ] [ Designated as safety issue: No ]
compare elapsed time to ovulation between treatment regimens [ Time Frame: up to 10 weeks after treatment ] [ Designated as safety issue: No ]
evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start [ Time Frame: up to 12 weeks after treatment ] [ Designated as safety issue: No ]
describe the prevalence of domestic violence in a medical abortion research population [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Mifepristone at Same Time Multicenter Study

Official Title ^ICMJE

A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Medical Abortion

Intervention ^ICMJE

Drug: mifepristone and misoprostol

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1128

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -

Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00269568

Other Study ID Numbers ^ICMJE

pittirb0404133

Has Data Monitoring Committee

Responsible Party

Mitchell Creinin, MD, University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Anonymous

Investigators ^ICMJE

Principal Investigator:

Mitchell D Creinin, MD

Universtity of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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