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

NCT00286208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1443

Last updated 2014-02-19

No results posted yet for this study

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?

Conditions

  • Induced Abortion

Interventions

DRUG

Mifepristone, misoprostol

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Sheila Raghavan, M.Sc. · Gynuity Health Projects

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Rasha Dabash, MPH · Gynuity Health Projects

  • Selma Hajri, MD · Reproductive Health Consultant

  • Ayse Akin, MD, MPH · Baskent University

  • Ilana Dzuba, MHS · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Moldova
  • Tunisia
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286208 on ClinicalTrials.gov