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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00286208
First received: February 1, 2006
Last updated: February 18, 2014
Last verified: February 2014

February 1, 2006
February 18, 2014
August 2005
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
Complete list of historical versions of study NCT00286208 on ClinicalTrials.gov Archive Site
  • Side effects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Acceptability for women [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Side effects
  • Acceptability for women
Not Provided
Not Provided
 
Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
A Randomized 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 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?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Induced Abortion
Drug: Mifepristone, misoprostol
  • Active Comparator: Sublingual Misoprostol
    400 mcg of sublingual misoprostol
    Intervention: Drug: Mifepristone, misoprostol
  • Active Comparator: Oral Misoprostol
    Misoprostol administered orally
    Intervention: Drug: Mifepristone, misoprostol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1443
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Moldova, Republic of,   Tunisia,   Turkey
 
NCT00286208
1.1.5
Not Provided
Gynuity Health Projects
Gynuity Health Projects
Not Provided
Study Director: Sheila Raghavan, M.Sc. Gynuity Health Projects
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Principal Investigator: Selma Hajri, MD Reproductive Health Consultant
Principal Investigator: Ayse Akin, MD, MPH Baskent University
Study Director: Ilana Dzuba, MHS Gynuity Health Projects
Gynuity Health Projects
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP