A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Gynuity Health Projects1 site in 1 country550 target enrollmentJuly 2007

ConditionsAbortion, Induced

InterventionsMisoprostol

DrugsMisoprostol

Overview

Phase: Not Applicable
Intervention: Misoprostol
Conditions: Abortion, Induced
Sponsor: Gynuity Health Projects
Enrollment: 550
Locations: 1
Primary Endpoint: Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

March 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Gynuity Health Projects

Eligibility Criteria

Inclusion Criteria

•Gestational age less than or equal to 63 days
•General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
•Willing to provide an address and/or telephone number for purposes of follow-up.