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Clinical Trials/NCT00286208
NCT00286208
Completed
Not Applicable

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

Gynuity Health Projects9 sites in 3 countries1,443 target enrollmentAugust 2005
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ConditionsInduced Abortion
InterventionsMifepristone, misoprostol
DrugsMifepristone, misoprostol

Overview

Phase
Not Applicable
Intervention
Mifepristone, misoprostol
Conditions
Induced Abortion
Sponsor
Gynuity Health Projects
Enrollment
1443
Locations
9
Primary Endpoint
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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?
Registry
clinicaltrials.gov
Start Date
August 2005
End Date
January 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gynuity Health Projects
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Sublingual Misoprostol

400 mcg of sublingual misoprostol

Intervention: Mifepristone, misoprostol

Oral Misoprostol

Misoprostol administered orally

Intervention: Mifepristone, misoprostol

Outcomes

Primary Outcomes

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

Time Frame: 2 weeks after mifepristone administration

Secondary Outcomes

  • Side effects(48 hours)
  • Acceptability for women(2 weeks)

Study Sites (9)

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