Official Title: “Acceptability and Feasibility of Medical Abortion in Puerto Rico: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation”

This study will examine the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico. The study will also observe the efficacy and acceptability of buccal administration of 800 mcg of misoprostol following 200 mg of mifepristone.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: 200 mg mifepristone followed by 800 mcg buccal misoprostol

Primary Measures

• efficacy

Secondary Measures

• acceptability

Inclusion Criteria:

• Gestation up to 63 days
• General good health
• Willingness to provide contact information for follow-up
• Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion Criteria:

• Ectopic pregnancy
• Intrauterine device (IUD) in place

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

Hector Diaz Martinez, MD Principal Investigator Clinica de Planificacion Familiar  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386282

Study ID Number: 1.1.4

ClinicalTrials.gov Identifier: NCT00386282

Health Authority: United States: Food and Drug Administration