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

Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation: A Non-inferiority Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02314754

Acronym

XXGA

Enrollment

719

Registered

2014-12-11

Start date

2014-12-31

Completion date

2016-04-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Abortion

Brief 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.

Interventions

DRUGMifepristone followed by misoprostol 24-48 hours later

200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

11 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason	7-36 days	Efficacy of medical abortion in the later first trimester as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason

Secondary

Measure	Time frame	Description
Proportion of Individual Side Effects Experienced by Participants	7-14 days	Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants
Proportion of Women Who Determine Method Acceptable	7-14 days	overall acceptability, time to complete abortion, bleeding, side effects, pain
Proportion of Providers Who Determine Method Acceptable	7-36 days	As assessed by service provider semi-structured interviews

Countries

Azerbaijan, Georgia, Mexico, United States, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026