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OpenTrials
Completed

NCT Number: NCT00269568

Mifepristone at Same Time Multicenter Study

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%

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Key information

Conditions

Abortion Seekers

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pregnancy equal to or less than 63 days at enrollment -

Exclusion criteria

abnormal pregnancy diagnosed by ultrasound

-

Treatment and study plan

mifepristone and misoprostol

Drug

Primary outcomes

  1. complete abortion rate

    Time frame: 5 weeks after treatment

Secondary outcomes

  1. to compare complete abortion rates by gestational age

    Time frame: 5 weeks after treatment

  2. compare bleeding and side effect profiles

    Time frame: up to 5 weeks after treatment

  3. compare acceptability of the two regimens

    Time frame: 2 weeks after treatment

  4. 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

  5. measure time to first ovulation

    Time frame: up to 10 weeks after treatment

  6. compare elapsed time to ovulation between treatment regimens

    Time frame: up to 10 weeks after treatment

  7. evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start

    Time frame: up to 12 weeks after treatment

  8. describe the prevalence of domestic violence in a medical abortion research population

    Time frame: at time of enrollment

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: MAST

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 23, 2005
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.