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

Gynuity Health Projects

Status and phase: Completed; Phase 4

Conditions: Medical Abortion

Treatments: Drug: Mifepristone followed by misoprostol 24-48 hours later

Study type: Interventional

Funder types: Other

Identifiers

NCT02314754

1016

Details and patient eligibility

About

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.

Enrollment: 719 patients

Sex: Female

Ages: 11 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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719 participants in 2 patient groups

71-77 days gestational age

Experimental group

Description:

Women whose pregnancies are estimated to have a gestational age of 71-77 days.

Treatment:

Drug: Mifepristone followed by misoprostol 24-48 hours later

64-70 days gestational age

No Intervention group

Description:

Women whose pregnancies are estimated to have a gestational age of 64-70 days.( Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range).