Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• intrauterine pregnancy between 64 days and 77 days' LMP

• eligible for medical abortion according to study doctor assessment

• willing and able to sign consent form

• speak english or spanish (in US sites); speak the local language(s) (in international sites)

• agree to comply with the study procedures and visit schedule

Exclusion Criteria:

• Have known allergies or present other contraindications to mifepristone or misoprostol