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

Sponsor

Gynuity Health Projects (Other)

Overall Status

Completed

CT.gov ID

NCT00386867

Collaborator

(none)

1,200

Enrollment

Locations

Duration (Months)

150

Patients Per Site

30.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Abortion, Induced	Drug: 800 mcg misoprostol via oral or buccal administration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2006

Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

efficacy []

Secondary Outcome Measures

acceptability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Family Planning Associates Medical Group	Chicago	Illinois	United States
2	Planned Parenthood League of Massachusetts (Boston clinic)	Boston	Massachusetts	United States
3	Columbia University Medical Center, Division of Obstetrics & Gynecology	New York	New York	United States
4	Institute for Urban Family Health	New York	New York	United States
5	Parkmed	New York	New York	United States
6	University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences	Pittsburgh	Pennsylvania	United States
7	Whole Women's Health	Austin	Texas	United States
8	Planned Parenthood	Waco	Texas	United States