Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally. The goal of this study is to provide answers to the following four questions: 1. Is a regimen of...

Date First Received: February 1, 2006

Last Updated: May 5, 2008

Verified by: Gynuity Health Projects, May 2008

Clinical Trial Phase: N/A | Start Date: August 2005

Overall Status: Completed

Estimated Enrollment: 980

Brief Summary

Official Title: “A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation”

Condition Keyword(s):

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

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

1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?

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

3. Is sublingual administration of misoprostol acceptable to women?

4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Mifepristone, misoprostol

Outcome Measures for this Clinical Trial

Primary Measures

  • Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.

Secondary Measures

  • Side effects
  • Acceptability for women

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Women presenting for medical abortion who consent to participate
  • Possibility of final gestational age of less than or equal to 63 days
  • General good health
  • Willing to provide contact information 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: N/A

Maximum Age for this Clinical Trial: N/A

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

Clinical Trial Sponsor Information

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Sheila Raghavan, M.Sc. Study Director Gynuity Health Projects  

Additional Information

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00286208

Study ID Number: 1.1.5

ClinicalTrials.gov Identifier: NCT00286208

Health Authority: Moldova: Hospital Ethical Review Committee

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