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

Medical Abortion Clinical Trial

— XXGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314754
• Other study ID #: 1016
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2014
• Last updated: July 13, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• Mifepristone followed by misoprostol 24-48 hours later
200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone

Locations

Country	Name	City	State
Azerbaijan	Scientific Research Institute of Obstetrics and Gynecology	Baku
Georgia	David Gagua Clinic	Tbilisi
Mexico	Clínica Comunitaria Santa Catarina	Mexico City
United States	Atlanta Women's Center	Atlanta	Georgia
United States	Family Planning Associates Medical Group	Chicago	Illinois
United States	John H. Stroger, Jr. Hospital of Cook CountY	Chicago	Illinois
United States	Hartford GYN Center	Hartford	Connecticut
Vietnam	Hung Vuong Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

United States,  Vietnam,  Azerbaijan,  Georgia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as determined by the proportion of successful terminations without surgical intervention (suction curettage or D&C) for any reason	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	7-36 days	Yes
Secondary	Proportion of Individual Side Effects Experienced by Participants	Side effects include diarrhea, nausea, vomiting, fever, chills, headaches, dizziness and/or weakness experienced by participants	7-14 days	Yes
Secondary	Proportion of Women Who Determine Method Acceptable	overall acceptability, time to complete abortion, bleeding, side effects, pain	7-14 days	No
Secondary	Proportion of Providers Who Determine Method Acceptable	As assessed by service provider semi-structured interviews	7-36 days	No