A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

Abortion, Induced Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386867
• Other study ID #: 1.1.3
• Status: Completed
• Phase: N/A
• First received: October 10, 2006
• Last updated: June 1, 2007
• Start date: October 2006
• Est. completion date: March 2007

Study information

• Verified date: June 2007
• 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

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be willing and able to sign consent forms;

• be eligible for medical abortion according to clinician’s assessment;

• be willing to undergo a surgical completion if necessary;

• have ready and easy access to a telephone and emergency transportation;

• speak English, Spanish, or have a translator available to translate for all study procedures; and,

• agree to comply with the study procedures and visit schedule.

Exclusion Criteria:

• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;

• IUD in place;

• Chronic renal failure;

• Concurrent long-term corticosteroid therapy;

• History of allergy to mifepristone, misoprostol or other prostaglandin;

• Hemorrhagic disorders or concurrent anticoagulant therapy;

• Inherited porphyrias; or

• Other serious physical or mental health conditions.

Study Design

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

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• 800 mcg misoprostol via oral or buccal administration

Locations

Country	Name	City	State
United States	Whole Women’s Health	Austin	Texas
United States	Planned Parenthood League of Massachusetts (Boston clinic)	Boston	Massachusetts
United States	Family Planning Associates Medical Group	Chicago	Illinois
United States	Columbia University Medical Center, Division of Obstetrics & Gynecology	New York	New York
United States	Institute for Urban Family Health	New York	New York
United States	Parkmed	New York	New York
United States	University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences	Pittsburgh	Pennsylvania
United States	Planned Parenthood	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy
Secondary	acceptability

External Links

•   Link