Mifepristone at Same Time Multicenter Study (MAST)
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Purpose
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%
| Condition | Intervention | Phase |
|---|---|---|
|
Medical Abortion |
Drug: mifepristone and misoprostol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days |
- complete abortion rate [ Time Frame: 5 weeks after treatment ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 1128 |
| Study Start Date: | June 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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%.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -
Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound
-
Contacts and Locations| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Mitchell D Creinin, MD | Universtity of Pittsburgh |
More Information
Publications:
| Responsible Party: | Mitchell Creinin, MD, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00269568 History of Changes |
| Other Study ID Numbers: | pittirb0404133 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
medical abortion mifepristone misoprostol |
Additional relevant MeSH terms:
|
Mifepristone Misoprostol Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic |
Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on May 23, 2013