This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?

2. Are the side effects with buccal use tolerable for women?

3. Is buccal administration of misoprostol acceptable to women?

4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Intervention(s) in this Clinical Trial

• Drug: Mifepristone, misoprostol
  • 200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
• Drug: mifepristone, misoprostol
  • 200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 200mg mifepristone followed by 400mcg misoprostol
• Active Comparator: 2
  • 200mg mifepristone followed by 800mcg misoprostol

Primary Measures

• Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).
  • Time Frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit
    Safety Issue?: No

Secondary Measures

• Side-effects, acceptability for women
  • Time Frame: side effects and acceptability recorded at exit interview
    Safety Issue?: No

Inclusion Criteria:

• Women 18 years or over presenting for abortion services who consent to participate
• good general health
• assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on
• Study Day 1 and to be eligible for medical abortion
• Have ready access to a telephone and emergency transportation;
• Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion Criteria:

• Conditions which contraindicate the use of mifepristone or misoprostol
• Women presenting for medical abortion who do not consent to participate

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Beverly Winikoff, MD, MPH Principal Investigator Gynuity Health Projects  

Overall Contact: Tamuna Tsereteli, MD, MSc, PhD  ttsereteli@gynuity.org

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00482209

Study ID Number: 1.1.6

ClinicalTrials.gov Identifier: NCT00482209

Health Authority: United States: Institutional Review Board