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Clinical Trials/NCT01173003
NCT01173003
Completed
Not Applicable

An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

Gynuity Health Projects1 site in 1 country688 target enrollmentJune 2009
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ConditionsInduced Abortion
DrugsMifepristone, misoprostol

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Induced Abortion
Sponsor
Gynuity Health Projects
Enrollment
688
Locations
1
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 CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

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

  1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual 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. Are women satisfied with counseling and services received in new centers offering medical abortion?
Registry
clinicaltrials.gov
Start Date
June 2009
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
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

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 (1)

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