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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

719 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Extended Gestational Age Medical Abortion Study

NCT00997347

Medical Abortion

COMPLETED PHASE4

A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks

NCT02720991

Abortion, 3 Months

COMPLETED PHASE4

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

NCT05119439

Medical Abortion

TERMINATED PHASE4

Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

NCT01856985

Medical Abortion

COMPLETED PHASE4

Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

NCT01966874

Medical; Abortion, Fetus

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medical Abortion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

71-77 days gestational age

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

Group Type EXPERIMENTAL

Mifepristone followed by misoprostol 24-48 hours later

Intervention Type DRUG

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

64-70 days gestational age

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mifepristone followed by misoprostol 24-48 hours later

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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