Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks

Phase 4

Waitlist Available

Led By Beverly Winikoff, MD, MPH

Research Sponsored by Gynuity Health Projects

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-14 days after initial visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests a medical abortion method using two medications for women in the early stages of pregnancy. The first pill stops the pregnancy, and the second helps expel it. These medications are approved by the United States Food and Drug Administration for this purpose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-14 days after initial visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-14 days after initial visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days after initial visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason

Secondary study objectives

Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization

Proportion of participants who determine method acceptable

Proportion of participants who report each individual side effect

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 78-84 days of gestational ageExperimental Treatment1 Intervention

Pregnant people whose pregnancies are estimated to have a gestational age of 78-84 days.

Group II: 71-77 days of gestational ageActive Control1 Intervention

Pregnant people whose pregnancies are estimated to have a gestational age of 71-77 days. (Participants in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).

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